DESC:Form 2
THE PATENT ACT, 1970
(39 OF 1970)
&
THE PATENT RULES, 2003
COMPLETE SPECIFICATION
(SEE SECTION 10 AND RULE 13)

HERBAL ORAL COMPOSITION IN HPMC CAPSULE FORM FOR MANAGEMENT OF PRIMARY DYSMENORRHEA

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 an herbal oral composition in HPMC capsule form consisting of Asafetida (hing) oil for management of primary dysmenorrhea and the method of preparation including band sealing of capsules.

BACKGROUND OF THE INVENTION
Menstruation is one of major sign in women’s healthy reproductive and endocrine system. It is a natural phenomenon as a part of the natural progress of reproductive life in women. However, the same menstruation is associated with unbearable pain causing primary dysmenorrhea (PD).
Primary dysmenorrhea (PD) is a chronic health condition affecting large population of young women with about 90% Prevalence rates. Primary dysmenorrhea typically occurs in adolescence and is a common cause of absenteeism and reduced quality of life in women. It is associated with recurrent, cramping pain, occurring during menses, and lacks any identifiable reproductive system pathology. While cramping pain may be the only complaint, one or more of the following symptoms may accompany the pain: nausea, breast tenderness, diarrhea, fatigue, headache, dizziness, and more rarely, syncope and fever. PD is usually treated by synthetic pharmacological agents and over the counter drugs including variety of painkillers and hormonal contraceptives etc that are often accompanied by adverse side effects.
Existing treatments and their drawbacks-
- Natural remedies: Natural remedies include yoga, intake of supplements including vitamin D, Magnesium etc, acupuncture, acupressure, breathing and relaxing exercises, however these remedies provide relief from pain for just a limited time period and there is recurrence of pain.
- Drug based treatment/Pharmacological methods- Drug based treatments include use of hormonal contraceptives, Non-steroidal anti-inflammatory drugs including analgesics and anti-inflammatory agents, Acetaminophen (Paracetamol). However, synthetic drugs are associated with number of side effects and there is potential risk in using hormonal contraceptives, hence these are not considered the effective methods for pain reductions.
- Non-Pharmacological Interventions- Non-pharmacological interventions involve use of heating pads for topical heat applications, battery operated devices including Transcutaneous electrical nerve stimulation (TENS) based devices that deliver low intensity vibrations to relieve the pain. However, these provide pain relief until when they are use or applied topically to the skin, hence are not suitable to provide effective and long term pain relief.
- Herbal treatment- Herbs have been indicated for usefulness in treatment of Primary dysmenorrhea. Various herbs including ginger, fennel, peppermint, cinnamon, etc, when consumed in whole has proven their effectiveness in management of primary dysmenorrhea. Asafetida also has effectiveness in pain reduction, however, when it is used in the form of powder, resin or in other form, the efficacy is lesser. However, due to an unpleasant taste of raw herbs, their consumption is limited, hence their use if restricted.
Hence there is an unmet need for the development of formulation comprising herbal ingredient for the management of primary dysmenorrhea, which if taken orally provides great effectiveness with higher efficacy.
Problem addressed and Technologically Advancement achieved-
In view of drawbacks associated with drug based pharmacological methods, non-pharmacological and natural remedies, the inventors of present invention came up with an innovative approach to address the problem in holistic and therapeutically effective manner, which is not done by anyone till date. Present invention offers and oral composition in the form of HPMC capsule, which when taken at the dose of just two capsules per day for period of 2 cycles, initiates the primary dysmenorrheal pain reduction immediately, without any considerable side effects. There are many herbs comprising thousands of phytochemicals available having effectiveness in pain management, however out of all these, the inventors of present invention selected Asafetida oil after considerable research and efforts.
Ferula asafoetida i.e., Hing is the oleo-resin gum extracted from the stem and rhizome of the Ferula asafetida plant. It is commonly called Hing or Devil's dung. It is a native species of Iran, Afghanistan and Pakistan. In Ayurveda, it is described as an analgesic agent. It carries a strong, tenacious and sulfurous odor. It is also used as a spice or as a condiment in various cookeries as a flavor like in curries, fresh vegetables, meat, pickles and pulses. Asafetida is distinguished as asafetida hing (hing) and asafetida (hingra). Traditionally, the plant is used to treat diseases like whooping cough, asthma, bronchitis, epilepsy, ulcer, stomach ache, flatulence, bronchitis, antispasmodic, intestinal parasites, influenza and weak digestion. The main active constituents present in the Ferula asafetida plant possesses various therapeutic and pharmacological properties like antioxidant, antimicrobial, antifungal, antiviral, antitumor, antimicrobial, ant diabetic, antispasmodic, hypertensive, hepatoprotective, neuroprotective and antiviral properties. Hing/asafetida is rich in free radical scavengers and give multiple benefits including relieving menstrual pain.
Asafetida, when consumed orally directly in form of powder or resin itself would not be effective in management of primary dysmenorrhea as being achieved in present invention. As anything which is consumed orally, usually enters the stomach, and gets mixed with the stomach fluids, which initiate changes in the composition during digestion process. Also, when these formulations are used in the form tablets or ointments etc., their bioavailability and stability is very less and tablets and other formulations takes a longer time to release the drug within the blood stream, hence provide desired effects very slowly and has a slow disintegration rate. Thus, in order to solve this problem of lesser bioavailability and slower drug release, the inventors of present invention loaded the oil formulation of asafetida (Hing) in “HPMC based capsules”, which has higher bioavailability, higher stability and faster disintegration rate, results in enhancing the efficacy of the formulation, as the formulation does not directly come in the contact with digestive fluids disturbing the characteristics of the composition and releases higher amount of the drug to the blood stream, thus provide efficacious and quick effect, in comparison tablet, oil or ointment based drug delivery system.
The related prior art is provided as below-
PRIOR ART
Prakanya K, Paheerathan V and Piratheepkumar R; Evaluate the efficacy of Ferula asafoetida resin on pain of karppa Vayu (primary dysmenorrhea); International Journal of Advanced Research and Review; 7(5), 2022; 24-39
In above cited research articles, Ferula asafoetida is provided to the patients in the form of resin powder, orally, thrice a day 650mg and 500mg respectively with the onset of pain, for 3 continuous menstrual cycles. The preparation process comprises steps of collecting five hundred gram of Ferula asafetida resin, frying the same with cow’s ghee and powdering using mortar pestle. Then the prepared powder is weighed and either 500mg or 650 mg filled into empty capsules.
The HPMC capsules comprising hing oil specifically is not disclosed in above cited research article, however, the above cited article is disclosing use of resin powder, which has lesser bioavailability in comparison to oil.
Shubha M; effect of Shoditha hingu (Ferula asafoetida linn) prayoga in the management of Kastarthava (primary dysmenorrhoea) - a case report; AYUSHDHARA An International Journal of Research in AYUSH and Allied Systems; 17.12.2021
The above cited article, 500mg hing is fried in two spoons of cow’s ghee and administered to the patient three times a day on the first and second day of menstruation before the food.
Present invention discloses a HPMC capsule consisting of hing oil whereas the above cited article discloses hing resin fried in ghee, hence both inventions differs from each other.
Asma K, Arshiya Sultana, Khaleequr Rahman; A single-blind randomized comparative study of Asafoetida vs Mefenamic acid in dysmenorrhea, associated symptoms and health-related quality of life; Journal of Herbal Medicine 9 (2017) 21–31
The above cited article discloses an oral capsules formulation prepared using whole oleo-gum resin of Ferula asafoetida. The asafoetida resins are cleaned, sieved through mesh size of 100, mixed well to form fine powder. Then the combination of 250mg powder and 250 mg mefenamic acid is filled in the capsules using capsules filling machine. The patients are administered with two capsules per day for 5 consecutive cycles. Further, the efficacy studies are examined using VAS score, VMSS score and SF-36 questionnaire.
Present invention is devoid of any synthetic drugs, which are being used in above cited article. Further, in present invention, HPMC capsules comprising asafoetida oil are disclosed, whereas the capsules disclosed in above cited article comprises of whole oleoresin capsule along with synthetic drug.

OBJECT OF THE PRESENT INVENTION
The main object of the present invention is to disclose a herbal composition in the form of HPMC capsules comprising 15 mg Asafeotida (hing) oil, which is efficacious and quick in the management of primary dysmenorrhea.

Another object of the present invention is to disclose herbal formulation, managing primary dysmenorrhea without side effects.

SUMMARY OF THE INVENTION
The present invention discloses oral composition in the form of HPMC based for the management of primary dysmenorrhea. The disclosed composition consists of asafetida (hing) oil as an active ingredient and Frankincense oil and coconut oil as inactive ingredients/ excipients. The process of preparation of HPMC (Hydroxy Propyl Methyl Cellulose) based capsules consists of steps of blending asafetida (hing) oil with Frankincense oil and coconut oil followed by dispensing the blended oils into empty HPMC capsule shell, which are automatically filled in liquid filling machine. Further a banding solution containing binding agent IPA, HPMC and chocolate brown colour is added to the band sealing machine, where the hing oil containing capsules are band sealed. The disclosed oral formulation in the form of HPMC capsule is natural, low cost, highly efficacious and quick in management primary dysmenorrhea.

DESCRIPTION OF FIGURES-
Fig 1 Graphical representation of mean VAS Score
Fig 2 Graphical representation of mean VMSS score
Fig 3 to 11 Graphical representation of physical functioning, physical health, emotional problems, energy fatigue, emotional well-being, social functioning, pain, general health and health change respectively
Figure 12 to 14 Graphical representation for pictorial representation of blood loss assessment on pads, tampons and clots
Figure 15 to 24 Graphical representation for systemic symptoms such as Fatigue, Nausea, Anorexia, Fever, Headache, Vertigo, Diarrhoea, Vomiting, and Nervousness
Figure 25 Graphical representation for analgesic usage

DETAILED DESCRIPTION OF THE INVENTION
The present invention discloses an herbal oral composition in HPMC capsule form comprising Ferula asafeotida oil i.e., hing oil for management of primary dysmenorrhea. Earlier none of the researchers disclosed the use of hing oil based HPMC capsule for effective and efficient management of primary dysmenorrhea, hence the main idea behind the present invention is to provide the effectiveness of hing oil against primary dysmenorrhea using HPMC capsule based efficient and effective drug delivery system.
Specific use of HPMC capsules-
HPMC capsules are vegetarian capsules, completely manufactured using 100% plant based material i.e., hydroxypropyl methylcellulose, as HPMC capsules so not contain animal driven material, hence are considered as efficient and cost effective alternative over hard gelatin capsules also, HPMC capsules tolerate greater heat and humidity, thus preferred over gelatin capsules. Further HPMC capsules are easy to manufacture without using specific glues, binders, coatings etc as required in manufacturing tablets and other drug delivery agents. Moreover, the effectiveness of tablets in drug delivery is lower in comparison to capsules as capsules dissolve easily and early in stomach fluids and have greater bioavailability as capsules releases more amount of drug to the blood stream as compared to tablets. Gelatin or other animal based capsules such as bovine capsules etc takes about 20 minutes to get dissolved in stomach fluids and release drug, whereas HPMC capsules takes lesser time i.e., about 10 minutes to release the drug. HPMC capsules are free from plasticizers, preservatives, glycerol, propylene glycol, starch, gluten, residual solvents, etc, further the same are highly stable, possesses fast disintegration rate and has lower moisture content. Hence HPMC capsules are being used in present invention owning to their better efficacy, bioavailability as well as cost effectiveness.
Problem in filling Ferula asafoetida oil i.e., hing Oil in Hard Gelatin Capsules:
The thickness of a hard two-piece capsule shell is about 0.1 mm. The capsule shell acts as a container and/or a protective wall. The important matter for the capsule with oily fill is a permeability of vapor water and oxygen through the capsule shell, and moisture content in capsule shell. Because hard gelatin capsules contains 13% to 15% of water, water-sensitive drugs are not considered to be suitable to them. HPMC contains only from 4% to 6% of water in the shell and is able to be filled with water-sensitive drugs. The moisture content in the capsule shell also influences the brittleness of hard capsules. Capsules can be broken easily when the moisture content decreases to below of 10% in the gelatin capsule shell.
Sealing of hard gelatin capsules
One of the ways utilized to seal such capsule components in which oil or liquid is filled, is by "banding". This process employs the use of a warm gelatin band which is rolled onto the capsule at the juncture between the body and cap lip. The band is dried and cooled to form a ring on the cap edge and the body.
Band-sealing for hard capsules with oily fills is ordinarily effected with gelatin for hard capsules made of gelatin or with HPMC for hard capsules of HPMC. Same material in band-sealing as the material of construction for hard capsules can allow mutual dissolution of the material at the portion of sealing, thus yielding the potent bonding. On the other hand, pullulan and polyvinyl alcohol copolymers are soluble in water and when aqueous solutions of such materials are used in the sealing, leave the resultant hard capsule partly vulnerable to dissolution even after cooling the sealing portion.
For example, in Japanese Laid-Open Patent Publication Hei. 9-507217, a hard gelatin capsule, in which a polymer layer of PVA is laminated to a hard gelatin shell having a low water transport amount has been proposed.
Ref: https://www.k2pharm.cz/images/kestazeni/K2_Document_4.pdf
Thus it is obvious that banding solution and process of banding thereof is an important part of the hard Gel Oil Filled capsule which should not be brittle and must have a longer shelf life.
Encapsulating this hydrophobic oil is a challenge which the applicant has duly overcome.
METHOD OF PREPARATION
The method used for the preparation of HPMC capsules comprising Ferula asafetida (Hing) oil comprises of following steps:
Step 1- Procurement of ingredients:
The active pharmaceutical ingredient used in present invention is asafetida (Hing) oil and the same was procured from Synthite Industries Pvt. Ltd, Kolenchery Kerala and other inactive ingredients including Frankincense oil and Coconut oil were procured from M/s. Immuno Natural Oils Pvt. Ltd., Mandsaur, Madhya Pradesh, Aadrics Agro Products, Kochi, Kerala and other ingredients including HPMC capsules, HPMC, IPA, chocolate brown colour was procured from vendors
List of ingredients used and the ratios in which such ingredients are used are provided in table 1 below-
S.No. Ingredients Amount Function
1 Asafetida (Hing oil) 15mg Active ingredient
2 Frankincense oil 85 mg In Active Ingredient
3 Coconut oil 400 mg In Active Ingredient
4 HPMC – Flo Fit Size ‘0’ Capsules - Encapsulation
5 HPMC 0.025 ml Surfactant
6 IPA (Isopropyl Alcohol ) 2.8 mg Binding agent
7 Chocolate Brown Colour 0.03 mg Colorant
Table 1- Amount of ingredients used per capsule
Step 2- Filling of capsules:
Asafetida (Hing) oil, Frankincense Oil and Coconut Oil and empty HPMC capsule shells are loaded in Liquid filling machine, where the capsules are automatically filled.
Step 3- Preparation of banding solution:
For preparation of banding solution, binding agent IPA, HPMC and Chocolate Brown color are dispensed and are fed in the bath of the band sealing machine.

Step 4- Band sealing of the capsules:
Further the Hing oil filled HPMC 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 25oC for 15 minutes and further ejecting out the same from chute of the band sealing machine.

CLINICAL TRIALS AND EFFICACY-
The prepared Hing oil capsules are further analyzed for the efficacy and safety against Primary Dysmenorrhea. The efficacy and safety analysis was conducted on 15 female patients ageing 15-35 years with dysmenorrheal pain as examined on the basis of medical history, ultrasound and physical examination. The patients were administered with two capsules per day for period of two cycles.
The efficacy was determined by pain intensity reduction measured by visual analog scale (VAS).
Efficacy assessment of pain intensity (VAS Score)
Mean data of VAS Score
The Average score of pain intensity in before usage of Hing oil HPMC Capsules is 6.87±1.46
The Average score of pain intensity in cycle 1 after usage of Hing oil HPMC Capsules is 2.73±2.66, cycle 2 is 1.40±1.59, cycle 3 is 1.47±1.55
The Pain intensity demonstrated that the pain reduction started immediately after starting the treatment and continued to decline in the subsequent three consecutive (post cycle 1, post cycle 2, post cycle 3) menstrual cycles.
Parameter Variables
Baseline Assessment 6.87±1.46
Post cycle 1 2.73±2.66
Post cycle 2 1.40±1.59
Post cycle 3 1.47±1.55
Table 2- Mean data of VAS score
Efficacy assessment on verbal Multidimensional scoring system (VMSS)
The Verbal Multidimensional Scoring System (VMSS) is assessed to evaluate the working ability, the systemic symptoms and whether analgesia is required or not.
Workability:
The Average score of workability before usage of Hing oil HPMC Capsules is 2.27±0.88
The Average score of workability in cycle 1 after usage of Hing oil HPMC Capsules is 0.53±0.52, cycle 2 is 0.40±0.5, cycle 3 is 0.33±0.49
The Verbal Multidimensional Scoring System (VMSS) on workability have been improved immediately after starting the treatment in subsequent three consecutive (post cycle 1, post cycle 2, post cycle 3) menstrual cycles.
Systemic symptoms:
The Average score of Systemic symptoms such as nausea, vomiting, diarrhea, dizziness, fatigue, back pain, mild fever and headache before the treatment of Hing oil HPMC Capsules is 1.87±0.83.
The Average score of Systemic symptoms in after the treatment of Hing oil HPMC Capsules in cycle 1 is 0.60±0.51, cycle 2 is 0.47±0.52 and cycle 3 is 0.40±0.51
The Verbal Multidimensional Scoring System (VMSS) on systemic symptoms have been reduced after starting the treatment in subsequent three consecutive (post cycle 1, post cycle 2, post cycle 3) menstrual cycles.
Analgesic requirement:
The Average score of Analgesics requirement in before the treatment of Hing oil HPMC Capsules is 2.07±0.80.
The Average score of Analgesics requirement in after the treatment of Hing oil HPMC Capsules in cycle 1 is 0.27±0.46, cycle 2 is 0.13±0.35 and cycle 3 is 0.20±0.4.
The Verbal Multidimensional Scoring System (VMSS) on Analgesics requirement have been reduced after starting the treatment in subsequent three consecutive (post cycle 1, post cycle 2, post cycle 3) menstrual cycles.
Parameter Working ability Systemic symptoms Analgesics requirement
Baseline assessment 2.27±0.88 1.87±0.83 2.07±0.80
Post cycle 1 0.53±0.52 0.60±0.51 0.27±0.46
Post cycle 2 0.40±0.51 0.47±0.52 0.13±0.35
Post cycle 3 0.33±0.49 0.40±0.51 0.20±0.41
Table 3- Mean data of verbal multidimensional scoring system.
Efficacy assessment on health-related quality of life by sf-36 patient questionnaire-
The SF-36 questionnaire was used for Health-related Quality of life (HRQoL) assessment.
Physical Functioning-
Before treatment with hing oil HPMC Capsules - 30.67±7.04
After treatment with hing oil HPMC Capsules in cycle 1 is 94.00±4.7, cycle 2 is 94.33±4.95 and cycle 3 is 95.00±5.00. Graphical representation shown in figure 3.

Table 4- Mean data of physical functioning
Role limitations due to physical health
Before treatment with hing oil HPMC Capsules - 41.67±27.82.
After treatment with hing oil HPMC Capsules in cycle 1 is 91.67±12.20, cycle 2 is 93.33±11.44 and cycle 3 is 95.00±10.35. Graphical representation shown in figure 4.

Table 5- Mean data for role limitation due to physical health
Role limitations due to emotional problems
Before treatment with hing oil HPMC Capsules 31.13±29.47
After treatment with hing oil HPMC Capsules in cycle 1 is 86.68±16.89, cycle 2 is 88.90±16.25 and cycle 3 is 91.12±15.24. Graphical representation shown in figure 5.

Table 6- Mean data due to emotional problems
Energy/Fatigue
Before treatment with hing oil HPMC Capsules 35.00±9.64
After treatment with hing oil HPMC Capsules in cycle 1 is 84.00±4.31, cycle 2 is 85.00±5.00 and cycle 3 is 87.33±4.58. Graphical representation shown in figure 6.

Table 7- Mean data of energy/fatigue
Emotional well-being
Before treatment with hing oil HPMC Capsules 34.40±6.90
After treatment with hing oil HPMC Capsules in cycle 1 is 88.53±5.83, cycle 2 is 90.40±5.62 and cycle 3 is 91.73±3.53. Graphical representation shown in figure 7

Table 8- Mean data of emotional well being
Social Functioning
Before treatment with hing oil HPMC Capsules 20.00±6.34
After treatment with hing oil HPMC Capsules in cycle 1 is 91.67±6.10, cycle 2 is 93.33±6.45 and cycle 3 is 94.17±6.45. Graphical representation shown in figure 8

Table 9- Mean data of social functioning
Pain
Before treatment with hing oil HPMC Capsules 20.50±8.57
After treatment with hing oil HPMC Capsules in cycle 1 is 86.50±9.53, cycle 2 is 87.50±9.26 and cycle 3 is 91.00±7.66. Graphical representation shown in figure 9

Table 10- Mean data of pain
General health
Before treatment with hing oil HPMC Capsules 21.00±4.31
After treatment with hing oil HPMC Capsules in cycle 1 is 86.50±9.53, cycle 2 is 89.17±7.42 and cycle 3 is 94.00±7.25. Graphical representation shown in figure 10

Table 11- Mean data of general health
Health change
Before treatment with hing oil HPMC Capsules 25.00±16.37
After treatment with hing oil HPMC Capsules in cycle 1 is 88.33±12.91, cycle 2 is 90.00±12.68 and cycle 3 is 93.33±11.44. Graphical representation shown in figure 11

Table 12- Mean data of health change
From table 4 – 12, it is concluded that present invention significantly improved Physical functioning, Social functioning, Energy/fatigue, regarding pain, regarding General Health, limitations due to physical health and limitations due to Emotional problems on health-related quality of life immediately after starting the treatment in subsequent three consecutive (post cycle 1, post cycle 2, post cycle 3) menstrual cycles.
Efficacy assessment of menstrual blood loss by pictorial blood loss assessment score-
Pictorial blood loss assessment on pads, clots and tampons:
The mean score of Pictorial Blood Loss Assessment before the treatment with hing oil HPMC capsules on
Pads is 4.87±6.42, on clots is 3.93±1.83 and on tampons is 5.00±6.11.
The Average score of Pictorial Blood Loss Assessment on after the treatment with Hing oil HPMC Capsules-
In cycle 1 on pads is 5.67±6.11, on clots is 3.67±1.95 and on tampons is 5.87±3.40
In cycle 2 on pads is 6.00±6.21, on clots is 3.40±2.03 and on tampons is 5.93±3.79
In cycle 3 on pads is 6.40±7.28, on clots is 3.13±2.07 and on tampons is 6.20±3.55
Parameter Variables for blood loss on pads Variables for blood loss on Tampons Variables for blood loss on Tampons
Baseline Assessment 4.87±6.42 5.00±6.11 3.93±1.83
Post cycle 1 5.67±6.11 5.87±3.40 3.67±1.95
Post cycle 2 6.00±6.21 5.93±3.79 3.40±2.03
Post cycle 3 6.40±7.28 6.20±3.55 3.13±2.07
Table 13- Pictorial blood loss assessment on pads, Tampons and clots
Graphical representation shown in figure 12, 13 and 14
In present invention, interventions provides with increase in the amount of menstrual blood loss at each cycle after starting the treatment, however the amount of blood loss was within the normal limits and this effect was attributed to the emmenagogue property of the test product.
Efficacy assessment of hing oil by associated systemic symptoms-
The oral composition as disclosed in present invention exhibited a decrease in the severity of systemic symptoms such as Fatigue, Nausea, Anorexia, Fever, Headache, Vertigo, Diarrhoea, Vomiting, and Nervousness. Graphical representation shown in figure 15 to 24
S.NO Symptoms Baseline assessment Post cycle 1 Post cycle 2 Post cycle 3
1 Fatigue 2.20±0.68 0.73±0.70 0.60±0.63 0.53±0.64
2 Nausea 1.47±0.52 1.20±0.86 0.93±0.70 0.87±0.74
3 Anorexia 1.80±0.86 0.93±0.88 0.67±0.72 0.60±0.63
4 Fever 2.47±0.52 0.53±0.52 0.33±0.49 0.27±0.46
5 Headache 1.73±0.46 0.60±0.51 0.47±0.52 0.40±0.51
6 Vertigo 2.07±0.70 0.67±0.49 0.27±0.46 0.20±0.41
7 Diarrhea 1.67±0.72 0.40±0.51 0.20±0.41 0.13±0.35
8 Vomiting 1.53±0.52 0.33±0.49 0.27±0.59 0.20±0.41
9 Nervousness 2.20±0.77 0.47±0.52 0.31±0.35 0.27±0.46
Table 14- Mean data of associated systemic symptoms
From table 14 above, it is concluded that there is decrease in the severity of symptom-Fatigue, Nausea, Anorexia, Fever, Headache, Vertigo, Diarrhea, vomiting and nervousness immediately after starting the treatment in subsequent three consecutive (post cycle 1, post cycle 2, post cycle 3) menstrual cycles and further, it is also concluded that analgesics usage gradually reduced after starting the treatment with disclosed Hing oil capsules.
Analgesics usage-
The average score of analgesics usage before treatment with hing capsule of present invention is 2.20 ± 0.77
The average score of analgesics usage after treatment with hing capsule of present invention in cycle 1 is 0.73 ± 0.59, cycle 2 is 0.47 ± 0.52 and cycle 3 is 0.20 ± 0.41
The assessment on analgesics usage is reduced after starting treatment in subsequent 3 consecutive menstrual cycles. Graphical representation is shown in figure 25.
SAFETY EVALUATION:
Adverse (AE) and Serious Adverse Event (SAE)
Total number of AE reported: 0
Total number of SAE reported: 0
Hence, it is concluded that the hing oil capsules as disclosed in present invention represents a safe, effective treatment for menstrual pain, its associated systemic symptoms and to improve health-related quality of life, without any significant side effects.
The oral herbal composition in the form of HPMC capsules as disclosed in present invention is significant in effective and quick management of primary dysmenorrhea and associated symptoms without any severe or significant side effects.
Present invention is Novel as the same is not anticipated by any of the prior art patents of non-patents literature.
Inventive step by way of technological advancement lies in disclosure of HPMC based capsules loaded with herbal composition of Asafetida (Hing) oil, which is efficacious and quick in management of primary dysmenorrhea pain. Further, the HPMC capsules are 100% plant based and vegetarian and are cost effective and highly stable along with fast disintegration rate, thus present invention also offers significant economic advancement.
Industrial application is duly clear as present invention is of great medicinal importance, present invention is considerably managing the primary dysmenorrhea and its associated symptoms in effective and quick manner, without any significant side effects.
,CLAIMS:1. A herbal oral composition, free from side effects for management of Primary dysmenorrhea wherein the same consists of 15 mg Ferula asafetida (Hing) oil as an active ingredient, 85 mg Frankincense oil and 400 mg coconut oil as in-active ingredients in an enteric coated HPMC capsule form.

2. The process of preparation of the herbal oral composition as claimed in claim 1 wherein the same consists of following steps:
- load Asafoetida (Hing) oil, Frankincense oil, coconut oil, & empty HPMC capsules into liquid filling machine for automatic capsule filling;
- feed banding solution that contains 0.025 ml HPMC (surfactant), 2.8 mg IPA (Binding Agent) and 0.03 mg Chocolate brown color ( Colorant) into the bath of band sealing machine at room temperature.
- Feed oil filled HPMC capsules into the hopper of the band sealing machine to band seal the capsules;
- Drying the band at a temperature of 25 degree C for 15 minutes and ejected sealed capsules through the chute.

3. The herbal oral composition as claimed in claim 1 wherein the dosage is of two capsules per day for period of two menstrual cycles