Claims:WE CLAIM:

1. Neem seed oil based vaginal capsule for treatment of Abnormal Vaginal Discharge WHEREIN the same consists of cold pressed Neem seed oil as active ingredient in a quantity of 500 mg, said capsule being dissolvable in natural vaginal secretions at natural vaginal pH immediately.

2. The Neem seed oil based vaginal capsule as claimed in claim 1 WHEREIN the same is hard gelatin capsule.

3. The Neem seed oil based vaginal capsule as claimed in claim 1 WHEREIN the same is administered via vaginal route.

4. The method of preparation of the Neem seed oil based vaginal capsule as claimed in claim 1 WHEREIN the same consists of following steps:

- Cold pressed Neem seed oil and empty hard gelatin capsule shells are loaded in Liquid filling machine, where the capsules are automatically filled;
- Banding agent gelatin, Titanium dioxide, water and color are fed in the bath of the band sealing machine;
- Neem seed oil filled hard gelatin capsules are fed in the hopper of the band sealing machine so that the capsules get band sealed in the Band sealing machine;
- The prepared capsules are dried in the drying chamber for drying the band at a temperature of 45 deg C for 15 minutes;
- Final capsules are ejected out from the chute of the band sealing machine.
5. The Neem seed oil based vaginal capsule as claimed in claim 1 WHEREIN the same is 95% to 100 % effective against each of the pathogens T. vaginalis, Candida albicans and Bacterial vaginosis.

6. The Neem seed oil based vaginal capsule as claimed in claim 1 WHEREIN the same exhibits overall cure rate against multiple pathogens Candida albicans and T. vaginalis in a range of 60 to 70%

7. The Neem seed oil based vaginal capsule as claimed in claim 1 WHEREIN the same exhibits overall cure rate against multiple pathogens Candida albicans and Bacterial vaginosis in a range of 70 to 80%

8. The Neem seed oil based vaginal capsule as claimed in claim 1 WHEREIN the same exhibits overall cure rate against multiple pathogens Bacterial vaginosis and T. vaginalis in a range of 95% to 100%
, Description:
FORM 2
THE PATENTS ACT, 1970
(39 OF 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(SEE SECTION 10 AND RULE 13)

NEEM SEED OIL BASED VAGINAL CAPSULE FOR TREATMENT OF ABNORMAL VAGINAL DISCHARGE

NUTRA GRACE

B 11/7 & 11/8, IDA UPPAL
HYDERABAD, TELANGANA 500039, INDIA
Email id: sunil@nutragrace.com
Contact No. 9908181811

The following specification particularly describes the invention and the manner in which it is to be performed.
FIELD OF INVENTION

The invention generally relates to the field of Herbal Medicinal Formulations. More specifically, it pertains to Neem seed oil based vaginal capsules for treatment of Abnormal Vaginal Discharge.

BACKGROUND OF THE INVENTION

Abnormal Vaginal Discharge is one of the most common problem faced by most of the women. It is characterized by change in color, consistency, odor and volume. Vaginal itching, burning, soreness, dryness, dysuria, pelvic pain, intermenstrual bleeding, postictal bleeding, swelling around vulva etc. are some of the major symptoms associated with Abnormal Vaginal Discharge.

Abnormal Vaginal Discharge is most commonly caused by infections. Vaginal infections exist in form of Bacterial vaginosis, Vulvovaginal candidiasis or Trichomoniasis (Caused by Trichomonas vaginalis). Bacterial vaginosis is caused when normal lactobacilli flora decreased and is replaced by overgrowth of other anaerobic bacteria including Gardnerella vaginalis, Mobiluncus etc. Candidiasis is usually caused by yeast Candida albicans. (https://www.ouh.nhs.uk/microbiology/diagnostictests/atoz/documents/discharge.pdf). Other endo-cervical infections caused by Chlamydia trachomatic and Neisseria gonorrhea etc. can also lead to vaginal discharge, dysuria, pelvic pain, intermenstrual bleeding etc.
Noninfectious causes may include inflammation or allergies caused by use of deodorants, lubricants, disinfectants etc., foreign body vaginitis caused by retention of tampon, vaginal sponge, condom etc., Genital tumors including tumors of vulva, vagina, cervix etc. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7905126/pdf/SMJ-61-297.pdf)

Current medications used for treatment of Bacterial vaginosis involve the use of broad spectrum antibiotics such as metronidazole tablet or vaginal cream, Clindamycin vaginal cream, tinidazole etc. Fungal infection i.e., vaginal candidiasis is treated with the help of antifungal medications such as Fluconazole, Miconazole, terconazole, Clotrimazole tablet, cream or suppository.
Herbal formulations are also available for the treatment of abnormal vaginal discharge usually comprising blend of multiple ingredients such as coconut oil, Shea butter, tea tree oil etc. Herbal formulations are available in the form of tablets, gels, creams, vaginal suppositories etc.

Drawbacks of Existing treatments:
The use of Antibiotics is undesirable, as antibiotics and antifungal agents such as metronidazole, fluconazole etc. possesses various side effects including hives, itching, chills, skin rashes, Dizziness, stomach cramps etc. Further, Antibiotics also damages the natural normal flora of the vagina including lactobacilli, which results in recurrence of infections and further patients require re-treatment within few months. Moreover, Excess use of antibiotics may cause systemic toxicity through absorption from the vagina. (https://patents.google.com/patent/US20130108599A1/en)
Other formulations such as tablets, creams, gels and dissolving vaginal suppositories also possesses certain disadvantages, as tablets has lesser bioavailability, It is quite difficult and unhygienic to apply creams and gels inside the vagina, Further vaginal suppositories comprising natural or chemical ingredients usually dissolves immediately upon insertion within the vagina, possess minimal bio adherence to vaginal walls because these are not stable at normal body temperature and as a result, they have minimal effectiveness.

Innovative approach used by the inventors
In order to overcome the drawbacks of already existing treatments, inventors of the present invention came up with an approach of utilizing cold pressed oil extracted from seed of single natural herb i.e., Azadirachta indica for the treatment of Abnormal Vaginal Discharge. The Neem seed oil is formulated in the form of liquid filled hard gelatin capsule which can be inserted within the vagina.
Neem (Azadirachta indica) also known as Indian lilac, is a member of Meliaceae family. Neem Possesses a lot of therapeutic properties due to of presence of antioxidants and other active ingredients such as Azadirachtin, nimbolinin, nimbin, nimibidol, quercitin etc. Neem plant possesses, antimicrobial and antifungal properties, free radical scavenging properties, anti-inflammatory properties, helps in management of cancer etc.
As present invention discloses the utilization of single herb extract hence present invention possesses almost no side effects and hence is superior over the already existing chemical based antibiotics. Moreover, the liquid filled hard gelation capsule disclosed in present invention does not dissolve immediately upon administration, it will dissolve in naturally generated vaginal secretions, hence are more stable than other vaginal suppositories, further more capsules have higher bioavailability as compared to tablets or creams hence are more effectiveness.

Prior art studies discloses the utilization of cold pressed neem seed oil for the treatment of abnormal vaginal discharge. But Most of the prior art patents discloses utilization of other base ingredients such as Shea butter, coconut oil, tea tree oil, lavender oil, apple cider vinegar along with neem seed oil and none of the prior art discloses the preparation of hard gelatin capsule comprising only the oil extracted from single herb i.e., Azadirachta indica.
Moreover, the synergistic compositions disclosed in prior art patents are usually in the form of tablets, creams, gels or immediately dissolving suppositories which are not that stable and effective whereas in present invention the drug is administered inside the vagina in the form of capsules hence are more effective and have higher bioavailability. Furthermore, the formulation disclosed in present invention is easy to use, cheap, possesses no side effects and does not damage the normal vaginal flora as it comprises natural ingredient.

Before going into the details of the invention, the related prior arts are stated below:
Prior art Patents
Patent Application No: US20130108599A1 Discloses “Herbal Vaginal Compositions”
The above cite invention discloses an herbal vaginal composition, which comprises of various herbal ingredients including coconut oil, Shea butter, Neem oil, lavender oil, vitamin E, lactobacillus, green tea, tea tree, ylang-ylang oil, sweet orange, myrrh oil, frankincense, nirvanas base and clove oil. To prepare suppositories for vaginal or anal use the blended ingredients are refrigerated so that they are hardened, the suppositories are kept in refrigerator until they are used. When these suppositories will be inserted in vagina, they will slowly melt at body temperature, further these will be absorbed by the vagina.

The present invention differs from the above cited invention as in above invention, an herbal synergistic composition comprising various natural ingredients is disclosed, whereas present invention discloses neem seed oil filled hard gelatin vaginal capsules to overcome the problem of abnormal vaginal discharge and infections. In above cited invention, one of the ingredient is Neem oil whereas in present invention, only one raw material is used i.e., cold pressed Neem seed oil. Also in present invention, a proper capsule formulation comprising Neem seed oil is disclosed, which basically dissolves in natural vaginal secretions whereas in above cited invention, the blend of all raw material is first refrigerated and then inserted inside the vagina which is not hygienic.

Patent Application No.US20190275099A1 discloses “Natural treatment regimen for Vaginal Yeast Infections”
The above cited invention discloses an application device to insert in vagina, which comprises of medication formulation. The medication formulation is a liquid formulation comprising coconut oil, tea tree oil or neem oil and apple cider vinegar. The application device may be suppositories made up of base compound formed into dissolving capsule comprised of cocoa butter or similar substitutes such as polyethylene glycol, glycerinated gelatin, hydrogels etc. plastic syringes filled with liquid composition, cylindrical tampons and menstrual sea sponges absorbing liquid formulation can also be used for delivery of desired liquid formulation within the vagina according to present invention.

Present invention discloses neem seed oil filled hard gelatin vaginal capsules, which can be inserted within the vagina and overcome the problem of Abnormal Vaginal Discharge (AVD), whereas above cited invention discloses a synergistic composition comprising coconut oil, tea tree oil or Neem oil and apple cider vinegar, where the major ingredient is Coconut oil.

Patent Application No.WO2006082596A2 discloses “Neem oil contraceptive formulations”
The above cited invention discloses a stable non-synthetic herbal anti-fertility compositions having high spermicidal activity for intra vaginal administration comprising Neem oil and pharmaceutically acceptable excipients in suitably formulated dosage form for vaginal administration. The composition in above cited invention is formulated in the form of water washable mucoadhesive nano emulgel and dispersible fast disintegrating vaginal tablets. The tablets comprises of binders (Starch, sodium alginate, gelatin etc.), lubricants (stearic acid, talc, aerosol, PEG etc.), disintegrants (sodium starch glycolate, microcrystalline cellulose, starch) and diluents.

The present invention discloses a liquid filled hard gelatin vaginal capsule comprising neem oil to overcome the problem of abnormal vaginal discharge, whereas the above cited invention discloses vaginal nanogels or vaginal tablets with certain excipients, which act as a contraceptive. As capsules have higher bioavailability, hence capsules are slightly more effective than tablets.

Patent Application No.WO1984004675A1 discloses “Vaginal Capsule”

The above cited invention discloses a soluble soft gelatin capsule for controlling vulvo-vaginal infections. The gelatin capsule comprises of stable, dried and viable concentration of lactic acid bacteria. Vaginal capsules disclosed in above cited patent are administered through vagina.

The present invention discloses vaginal capsules comprising Neem seed oil to overcome the problem of abnormal vaginal discharge, whereas the above cited invention discloses vaginal capsules comprising lactic acid bacteria. Hence present invention differs from the above cited invention.

Indian Patent Application No. 202111024378 discloses “A Synergistic Herbal Formulation for treating Vaginal Infections and Method thereof”

The above cited invention discloses a synergistic herbal formulation for treating vaginal infections. The herbal formulation comprises of plant extract selected from group consisting of Azadirachta indica, Ficus benghalensis, Ficus glomerata, Ficus religiosa, Thespesia populnea, Ficus infectoria and Melaleuca alternifolia. The synergistic herbal formulation further comprises of lactic acids from AHA complex, natural fatty acids of coconut oil, soapnut extracts, glycerine, benzalkonium chloride, soya protein, wheat protein, sodium chloride, potassium sorbate, and fragrance. The synergistic formulation disclosed in above cited invention can be formulated as water soluble gels, foaming solution, soft gel, solutions, aerosols, creams, ointments, capsules, microcapsules, suppositories or tablets, preferably water soluble gels, capsules or tablets.

The present invention differs from the above cited invention, as present invention discloses a vaginal capsule comprising Neem oil only, which can be administered through vagina, whereas the above cited invention discloses a synergistic composition comprising various different ingredients along with that the formulation also comprises of soya protein lactic acid, wheat protein etc, which is not disclosed in the present invention.
Journals and Publications
G.P. Talwar, S. Garg, V. Dhar, R. Chabra, A. Ganju and S.N. Upadhyay “Praneem polyherbal cream and pessaries with dual property of contraception and alleviation of genital infections; Reproductive Biology.
The above cited journal discloses polyherbal preparations comprising purified extract of Neem seed (Praneem), quinine hydrochloride and saponins from reetha dispensed in water washable cream base. The formulation disclosed in above cited journal can be formulated in the form of cream or pressary.
The present invention differs from the above cited paper as present invention discloses vaginal capsules (Hard gelatin) made up of Neem seed oil, whereas the above cited vaginal formulation is available in the form of water washable cream or pressary, also the above cited journal involve utilization of 3 ingredients i.e., neem seed extract, quinine hydrochloride and saponins, whereas the present invention comprises the use of single herb oil i.e., neem oil only.

Olusola I.Aremu, Kokonne E. Ekere, Yetunde C. Isimi, Victoria C. Nwaogu, Olawale G. Agbaje , Olubunmi J. Olayemi, Musiliu O. Adedokun, Martins O. Emeje ; Formulation and Evaluation of Neem (Azadirachta indica A. Juss) Seed Oil Suppositories; Journal of Reports in Pharmaceutical Sciences.
The above cited research basically discloses a study to provide a scientific rationale for the preparation and use of neem seed oil suppositories prepared using dika fat (DF) and Macrogol (MG) as bases. The above cited paper, discloses pour moulding method for the manufacture of the suppositories in pre calibrated moulds. Further, Dika fat (DF) or Macrogol (MG) base and Neem seed oil are vigorously stirred together and melted at 50oC using magnetic stirrer. The prepared mixture was then poured into the mold until it overflowed, the mold content was allowed to solidify and further the suppositories are removed and packed.
The present invention discloses a vaginal capsule comprising neem seed oil, whereas the above cited paper discloses suppositories comprising neem seed oil with base such as dika fat or Macrogol.
R.S. Sharma, A.K. Mathur, N. Chandhiok, S. Datey, N.C. Saxena, S. Gopalan, S. Sharma, S. Mittal, R. Sehgal, B.K. Sumandal, A. Chanda, V. Salvi, N. Mutalik, K.J. Coyaji, A. Gibsson, K. Hazari, S. Kalgutkar, G.P. Talwar; Phase II clinical trial with Praneem polyherbal tablets for assessment of their efficacy in symptomatic women with abnormal vaginal discharge: Transactions of The Royal Society of Tropical Medicine and Hygiene, Volume 103, Issue 2, February 2009, Pages 167–172

The above cited study was conducted to determine the efficacy of Praneem polyherbal tablets for the treatment of symptomatic women with abnormal vaginal discharge syndrome. From the above study, it was observed that the cure rate was 77% for C. Albicans and 68% for Bacterial vaginosis. The active ingredient of the Praneem polyherbal tablet was purified extract of neem (Azadirachta indica).

The present invention discloses a vaginal capsule comprising of neem seed oil which helps in treatment of abnormal vaginal discharge, whereas the above cited journal discloses Praneem polyherbal tablets comprising neem extract as active ingredient which are effective against abnormal vaginal discharge syndrome. Capsules have higher bioavailability; hence capsules are slightly more effective than tablets. The present invention shows that cure rate for single pathogen T. vaginalis, Candida albicans and Bacterial vaginosis were 100, 100 and 100% respectively in comparison with cure rate of 77% for C. Albicans and 68% for Bacterial vaginosis in Praneem.

M. SaiRam, G. Ilavazhagan, S.K. Sharma, S.A. Dhanraj, B. Suresh, M.M. Parida, A.M. Jana, Kumar Devendra, W. Selvamurthy; Anti-microbial activity of a new vaginal contraceptive NIM-76 from neem oil (Azadirachta indica): Journal of Ethnopharmacology 71 (2000) 377–382

In the above cited study, Efficacy of NIM-76, a spermicidal fraction from neem oil, was investigated for its antimicrobial action against certain bacteria and fungi compared to whole neem oil. The NIM-76 preparation showed stronger anti-microbial activity than the whole neem oil. NIM-76 exhibited antifungal activity against Candida albicans. This shows that NIM-76 has a potent broad spectrum anti-microbial activity. The ability of NIM-76 to prevent the growth of C. albicans during systemic candidiasis and vaginal candidiasis indicated that NIM-76 is very useful even as a therapeutic agent against candidial and possibly other infections.

The above cited patent just discloses the antimicrobial property of NIM 76, which is a spermicidal fraction of neem oil, whereas present invention discloses a vaginal capsule, which comprises of neem seed oil, which is administered through vagina and helps in the treatment of abnormal vaginal discharge.

Mittal, Aruna ; Kapur, Sujala ; Garg, Sanjay ; Upadhyay, Shakti N. ; Suri, Sushma ; Das, Subodh K. ; Gupta, Sunanda ; Talwar, Gurusharan P. (1995) Clinical trial with Praneem polyherbal cream in patients with abnormal vaginal discharge due to microbial infections: Australian and New Zealand Journal of Obstetrics and Gynaecology, 35 (2). pp. 190-191. ISSN 0004-8666

The above cited journal discloses a study to determine the effectiveness of Praneem polyherbal cream, which comprises of neem seed extract against Chlamydial infections, which are the major cause of abnormal vaginal discharge.

The above cited paper discloses the effectiveness of Praneem herbal cream against abnormal vaginal discharge whereas on the other hand, the present invention discloses a neem seed oil vaginal capsule to overcome the problem of abnormal vaginal discharge.

Neem Oil Suppositories:
Ref: http://www.altcancer.com/neemsup.htm
The above cited neem oil suppositories comprise of cocoa butter, lecithin and neem tree oil.
The present invention discloses vaginal capsules comprising only of cold pressed neem seed oil.

Miconazole-3 200 mg-2% (9g) Vaginal Kit:
Ref: https://www.webmd.com/drugs/2/drug-11237/miconazole-3-vaginal/details
This medication is used to treat vaginal yeast infections. Miconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection. The vaginal product comes in 2 forms (a vaginal cream or tablet).
The present invention discloses a vaginal capsule comprising of herbal neem seed oil, whereas the above cited product is available in the form of Vaginal cream or tablet also the raw materials used are chemicals instead of natural ingredients

Thus a need was felt to develop a composition consisting of only neem seed oil in a vaginal capsule form which is easy to use, cost effective and possesses almost no side effects.

OBJECT OF THE PRESENT INVENTION
The main object of the present invention is to disclose Herbal Neem seed oil vaginal capsule for the treatment of abnormal vaginal discharge which can dissolve in the natural vaginal secretions.
Another object of the present invention is to disclose neem seed oil based liquid filled hard gelatin capsule which can provide about 90% effectiveness against pathogens and symptoms associated with abnormal vaginal discharge.
Further object of the present invention is to disclose neem seed oil based liquid filled hard gelatin capsule which is effective in treating infections relating to T. vaginalis, Candida albicans and Bacterial vaginosis to 100%.
Yet another object of the present invention is to disclose neem seed oil based vaginal capsule which is easy to use, cost effective and possesses almost no side effects.

SUMMARY OF THE INVENTION
Present invention discloses Herbal neem seed oil based vaginal capsules used for the treatment of Abnormal Vaginal discharge. The capsules disclosed in present invention are cold pressed neem seed oil filled hard gelatin capsules, which can be administered via vaginal route. The capsules dissolve in the natural vaginal secretions and provide about 90% to 100% effectiveness against pathogens and symptoms associated with abnormal vaginal discharge. The method of production comprises steps such as procurement of raw material, filling of capsules in liquid filling machine, preparation of banding solution, band sealing, drying and ejection of capsules from band sealing machine, efficacy and safety analysis of the prepared capsules. As present invention discloses the utilization of single herb hence present invention possesses almost no side effects and hence is superior over the already existing chemical based antibiotics used for the purpose. Moreover, the liquid filled hard gelation capsule disclosed in present invention does not dissolve immediately upon administration, it will dissolve in naturally generated vaginal secretions, hence are more stable than other vaginal suppositories, further more capsules have higher bioavailability as compared to tablets or creams hence have more effectiveness.

BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1: Graphical representation of Microbial cure rate with BC Caps treatment.
Figure 2: Graphical representation of Whiff test results after and before treatment.
Figure 3: Graphical representation of Ph before and after treatment with BC caps.
Figure 4: Graphical representation of %age improvement in lower abdominal pain before and after treatment
Figure 5: Graphical representation of %age improvement in Abnormal vaginal bleeding before and after treatment
Figure 6: Graphical representation of %age improvement in dysuria before and after treatment
Figure 7: Graphical representation of %age improvement in vaginal soreness before and after treatment
Figure 8: Graphical representation of %age improvement in vaginal dryness before and after treatment
Figure 9: Graphical representation of %age improvement in vulval edema before and after treatment

DETAILED DESCRIPTION OF THE INVENTION
The following description is of best-contemplated mode of carrying out the invention. The description is made for the purpose of illustrating the general principles of the invention and should not be taken in a limiting sense.
The present invention discloses herbal neem seed oil based vaginal capsule for treatment of abnormal vaginal discharge. The formulation disclosed in present invention is present in the form of liquid filled hard gelatin capsule which usually dissolves in natural vaginal secretions, hence possesses higher bioavailability.
Moreover the capsules disclosed in present invention are cost effective and possesses almost no side effects further the capsules are easy to administer and does not damage the normal flora of the vagina as natural ingredient is being used.
Preparation Methodology:
Procurement of Raw Material:
The active ingredient used for preparation of capsules is cold pressed Neem seed oil. Cold pressed Neem seed oil was procured from M/s. Immuno Natural Oils Pvt. Ltd., Mandsaur, Madhya Pradesh. Other inactive material such as Binding agent Gelatin, Antioxidant Vitamin E, Artificial colorants titanium dioxide and Apple green color and emulsifier Tween 80 were procured from vendors.
Table 1: Amount of ingredients per capsule:
S. No Ingredient Amount per capsule Function
1. Neem seed oil 500 mg Active ingredient
2. Gelatin 1 mg Binding agent
3. Vitamin E 500 mcg Antioxidant
4. Titanium dioxide 0.02 mcg Artificial colorant
5. Tween 80 0.025 mcg Emulsifier
6. Apple Green color 0.03 mcg Artificial colorant

Filling of Capsules:
Cold pressed neem seed oil and empty hard gelatin capsule shells are loaded in Liquid filling machine, where the capsules are automatically filled.

Preparation of banding solution:
For preparation of banding solution, banding agent gelatin, Titanium dioxide water and Apple green color are dispensed and are fed in the bath of the band sealing machine. Further the Neem seed oil filled hard gelatin capsules are fed in the hopper of the band sealing machine. The capsules get band sealed in the Band sealing machine.

Drying and ejection:
The prepared capsules are dried in the drying chamber for drying the band at a temperature of 45 deg C_for 15 minutes. And further ejected out from the chute of the band sealing machine.
The prepared caps are further INSPECTED and packed.

METHOD OF USE:
2 capsules are directly inserted fingerdeep into the vagina by the patient herself before bed daily for 15 days or more as suggested by the doctor without any side effect. The capsule dissolves completely very quickly within minutes of insertion, almost immediately in the vaginal secretion and need to have fresh capsules the next day.

Human Clinical trials and Data:
The product (named as BC Caps) is clinically tested on a sample size of 15 patients for efficacy.

1. Efficacy evaluation:
Administration: 15 patients were given neem seed oil capsules having confirmed abnormal vaginal discharge report and route of administration was vaginal. 2 capsules were administered to vagina before going to bed for 15 days.

Demographics and Measurement at baseline: Demographic data such as mean age, mean height, weight, marital status, qualification etc., were recorded. Further, basic health parameters such as body temperature, blood pressure, pulse rate etc. were recorded.
Table 2: Characteristics and mean variable of study subjects
S.No. Characteristics Variable %
1. Age 33.7 -
2. Height 162.7 -
3. Weight 71.78 -
4. Marital Status
• Married
• Unmarried
13
2
86.66%
13.33%
5. Indian 15 100%
6. Non Smoker 15 100%
7. Income
• 30,000-40,000
• 40,000-50,000
• 50,000-60,000
2
4
9
13.3%
26.6%
60.00%
8. Education
• Intermediate
• High school
• Degree
• Professional degree
5
5
4
1
33.33%
33.33%
26.6%
6.6%

Table 3: Basic Health Parameters screening
S. No Vital signs Variable
1. Body Temperature 98.3±0.08
2. Systolic blood pressure 118.80±7.43
3. Diastolic blood pressure 80.53±4.86
4. Pulse rate 78.4±6.33
5. Respiration rate 17.47±0.83

Determination of Vaginal discharge: On speculum examination, Abnormal vaginal discharge was observed in all 15 patients (100%) and cervical abnormalities were observed in 8 patients (56.33%)

Laboratory examination: Further laboratory examination of vaginal smear was conducted, which indicated the presence of pathogens in all the subjects.
Table 4: Details of pathogens:
S.No Pathogen Total subjects (N=15) Percentage %
1. Bacterial vaginosis 3 20.00
2. Candida albicans 1 6.67
3. T vaginalis 2 13.33
4. Bacterial vaginosis and Candida albicans 4 26.67
5. Bacterial vaginosis and T vaginalis 2 13.33
6. Candida albicans and T vaginalis 3 20.00

Efficacy of Capsules of the present invention against vaginal discharge:
Status of vaginal discharge on speculum examination before and after treatment with BC caps were determined, after 7 days and 14 days. It was observed that before treatment, 100% study subjects had abnormal vaginal discharge and after treatment with Neem seed oil capsules, after 7 days, 12/15 (80%) and after 14 days 14/15 (98.33%) study subjects had normal vaginal discharge. (Table 5)
Table 5: Status of Vaginal discharge on speculum examination before and after treatment with BC Caps for 7 days and 14 days.
Before Treatment n (%) After Treatment (Day 7)

Normal Discharge Abnormal
Discharge After Treatment (Day 14)
Normal Abnormal Discharge Discharge
Type of discharge at enrollment 15 12 3 14 1

% normal discharge
- 80 20 93.3 6.67

Efficacy of BC Caps against Cervical abnormalities:
Cervical abnormalities were observed in 8/15 (53.3%) of subjects before treatment and after 7 days of treatment with BC caps, 13/15 (86.6%) subject and after 15 days of treatment, 14/15 (93.33%) of subjects had normal cervical examination. (Table 6)
Table 6: Cervical abnormalities observed on speculum examination before and after treatment with BC Caps for 7 days and 14 days.
Type of discharge at enrollment Before treatment (N) After treatment
(Day 7) After treatment
(Day 14)
Abnormal
(N) 8(53.3%) 2 1
Normal (N) 7(46.6%) 13 14
% improvement - 86.6 93.3

Associated Symptoms before and after treatment:
Significant decline was observed in almost all of the symptoms after treatment for 7 and 14 days. It was observed that after 7and 14 days of treatment, 60% to 80% participants respectively ad no complaints of lower abdominal pain, 80% to 100% participants after 7 and 14 days respectively had no complaint of Abnormal vaginal bleeding. 66.7% after 7 days and 93.33% after 14 days had no complaints of vaginal soreness and vaginal dryness. Further there is 46.67% and 93.33% reduction in dysuria and 93.33% and 100% reduction in vulval edema after 7 and 14 days of treatment respectively. (Table: 7)
Table 7: Percentage (%) of subjects having associated symptoms at base line and after 7 and 14 days of treatment
Associated symptoms Category Baseline Day 7 Day 14
No. % No. % No. %

Lower Abdominal Pain None 2 13.333 9 60.000 12 80.000
Mild 11 73.333 6 40.000 3 20.000
Moderate 2 13.333 0 0.00 0 0.00
Severe 0 0.000 0 0.000 0 0.00

Abnormal Vaginal Bleeding None 10 66.667 12 80.000 15 100.00
Mild 5 33.333 3 20.000 0 0.0
Moderate 0 0.000 0 0.00 0 0.00
Severe 0 0.000 0 0.00 0 0.00

Dysuria None 0 0.000 7 46.667 14 93.333
Mild 13 86.667 8 53.333 1 6.667
Moderate 2 13.333 0 0.00 0 0.00
Severe 0 0.000 0 0.00 0 0.00

Vaginal Soreness None 0 0.000 10 66.667 14 93.333
Mild 7 46.667 5 33.333 1 6.667
Moderate 8 53.333 0 0.00 0 0.00
Severe 0 0.000 0 0.00 0 0.00

Vaginal Dryness None 0 0.000 10 66.667 14 93.333
Mild 2 13.333 5 33.333 1 6.67
Moderate 13 86.667 0 0.00 0 0.00
Severe 0 0.000 0 0.00 0 0.00

Vulval edema None 4 26.667 14 93.333 15 100.00
Mild 11 73.333 1 6.667 0 0.00
Moderate 0 0.000 0 0.00 0 0.00
Severe 0 0.000 0 0.00 0 0.00

Table 8: Other Assessment parameters before and after 14 days treatment with BC caps
S. No Assessment Parameter Baseline % Day 7 % Day 14 %
1 What is the color of the vaginal discharge Clear 0 0 3 20 15 100
White 14 93.3 11 73.3 0 0
Yellow 1 6.66 1 6.66 0 0
Brown 0 0 0 0 0 0
Green 0 0 0 0 0 0
2

Consistency of the vaginal discharge Thick white 4 26.6 4 26.66 5 33.3
Thin 0 0 11 73.3 10 66.6
Mucoid 10 66.6 0 0 0 0
Frothy 1 6.66 0 0 0 0
3 Odour of vaginal discharge Non offensive 0 0 7 46.6 12 80
Offensive 0 0 6 40 2 13.33
Fishy 2 13.3 2 13.33 1 6.66
others 13 86.6 0 0 0 0
4 Symptoms experienced by partner Recurrent dysuria 0 0 4 26.66 - -
Soreness 2 13.33 3 20 - -
Soreness Recurrent dysuria 13 86.6 3 20 - -
nil 0 0 5 33.3 - -

Microbiology and Cure rate:
Table 9: Effect of BC Caps on number of subjects carrying pathogens
Characteristics Before After
Pathogens detected Pathogens not detected Pathogens detected Pathogens not detected
Number of subjects carrying pathogen 15 0 1 14

Pathogens such as T. vaginalis, Candida albicans and Bacterial vaginosis were detected and it was observed and it was observed that cure rate for single pathogen T. vaginalis, Candida albicans and Bacterial vaginosis were 100, 100 and 100% respectively. Overall cure rate multiple pathogen i.e., Candida albicans + T. vaginalis, Candida albicans + Bacterial vaginosis and Bacterial vaginosis + T. vaginalis were 66.67, 75.00 and 100% respectively.
Table 10: Number and percentage of pathogens before and after treatment
S. No Type of Pathogen Pathogen before treatment Pathogen after treatment
No. % No. %
Improvement
1. Bacterial vaginosis 3 20.00 0 100%
2. Candida albicans 1 6.67 0 100%
3. Trichomonas vaginalis 2 13.33 0 100%
4. Bacterial vaginosis + Candida albicans 4 26.67 0 100%
5. Bacterial vaginosis and T vaginalis 2 13.33 0 100%
6. Candida albicans and T vaginalis 3 20.00 1 66.67

Whiff Test: Whiff test as basically conducted for odor analysis. Significant difference was observed in odor before and after treatment. Before treatment 100% women were having fishy odor and after treatment no fishy odor was observed in any of the women. (Table 10)
Table 11: Whiff test results before and after treatment
S. No Whiff test Before (N=15) After (N=15) Chi-square statistic P-value*
N % N %
1. Fishy Odour +ve
9 100.0 0 0 - P=0.0001
2. Fishy Odour -ve 6 0 15 100.0

The pH of the vagina: Vaginal pH was detected before and after treatment and it a significant difference was observed in vaginal pH before and after treatment. Earlier 20% women were with normal pH and after treatment, 93.33% women were with normal pH. (Table 11)
Table 12: Vaginal pH before and after treatment.
S. No Test Before (N=15) After (N=15) Chi-square statistic P-value*
N % N %
13. Normal pH of below or equal to 4.5
3 20.00 14 93.33
16.4253
.000051
14. Abnormal pH more than 4.5 12 80.00 1 6.66

*Significant at p < .05

Safety evaluation:
Safety evaluation studies discloses that only one subject out of 15 (6.66%) reported transient burning sensation during first 2 days of the insertion of capsules after which the patient was 100% comfortable during the entire course of treatment for next 13 days.
Table 13: Tabular representation of side effects due to BC caps
No of the subject in the enrollment (N) No. of subject had no side effect with B C CAPS (N) No. of subject had side effect with B C CAPS (N) Percentage of side effects in subjects enrolled.
15 14 1 6.66%

Hence it was observed that before treatment 100% subjects were having abnormal vaginal discharge and about 53.3% women were having cervical abnormalities. After treatment for 7 and 14 days, 80% and 93.33%subjects respectively had normal vaginal discharge. Further 86.6% and 93.36% reduction in cervical abnormalities was observed after7 and 14 days of treatment. Moreover the capsules are safer when administered. Hence present invention discloses the neem seed oil based capsules with 93.33% effectiveness and safety.
NOVELTY lies in disclosure of liquid filled hard gelatin vaginal capsules comprising neem seed oil, which can be administered via vaginal route. The capsules comprises of cold pressed neem seed oil and dissolves within the normal vaginal secretions.
INVENTIVE STEP of technological advancement lies in delivery of Neem seed oil to the vagina in form of hard gelatin capsules dissolvable at vaginal pH, possess higher bioavailability and moreover the capsules are hygienic and easiest way of administering the drug within the vagina. Moreover the neem seed filled hard gelatin vaginal capsules disclosed in present invention do not possess any side effects, are cost effective and provide almost 93.33% effectiveness against pathogens and other associated symptoms.

INDUSTRIAL APPLICATION is duly clear as above invention will boost up the medical sector as the disclosed vaginal capsules are quite effective against the abnormal vaginal discharge, also the capsules are quite cheap and easy to manufacture, moreover the capsules are made up of natural material hence possesses almost no side effects.