FIELD OF INVENTION
The present invention relates to herbal compositions and natural products. More specifically
it relates to a novel vaginal douche composition based on herbal extracts and can not only be
used as a female hygiene product but also as a therapeutic product for the control and
management of vaginal infections.
BACKGROUND OF THE INVENTION
A "douche" is a feminine hygiene product that women use to clean the vagina and check body
odors, especially during menstruation. The word "douche" is French for "wash". It is a method
to wash out the vagina, usually with a mixture of water and vinegar. Some douches, though,
also contain antiseptics and fragrances. Most women who douche buy a commercial
preparation sold in drugstores and supermarkets. A small percentage of women use a
homemade mixture of water and vinegar or water alone. Douche comes in a bottle or bag and
is sprayed upward into the vagina through a tube. Whether douching is beneficial or not is
debatable. It has both advantages and disadvantages as discussed below.
Advantages: Some women say douching makes them feel cleaner. Apart from the hygiene and
cleanliness factor, douching performs a very important function- checking vaginal infections.
The incidence of vaginal infections has more than doubled in the last 20 years. One reason that
they are becoming more prevalent is the increased use of antibiotics, which kill off beneficial
natural flora found in the vagina and allow more harmful bacteria and yeast to multiply.
However, using any 'douching agent' and performing douching in 'any manner' will not work.
To be effective, douching has to be carried out in a specific manner, using a suitable
composition. This is because over-douching or under-douching can alter effectiveness of the
process and lead to disadvantages rather than any benefits. Also, composition of the 'doucheJ
makes a lot of difference in checking vaginal infections. Douches based on herbal extracts and
natural ingredients offer a safe and effective solution to vaginal hygiene and control of vaginal
2
infections than the 'mass produced' chemical and synthetic douches, which can destroy the
natural pH of the vagina and upset the delicate balance of microflora in the vagina.
Herbal remedies are quite effective in combating vaginal infections, especially those caused by
Trichomoniasis, Yeast infections and Chlamydia. These together cause about 90 percent of all
vaginal infections. In fact a herbal douche is one of the best ways to treat minor vaginal
infections, if done properly. The spray should not be too forceful which can be taken care by
suspending the bag no higher than shoulder level. Also, douching should be used only to treat
an occasional infection, not as a daily freshener. A weekly douching can be quite safe and
effective, instead of a daily one which can end up doing more harm than good.
Common vaginal infections in which herbal douches are effective
Candida infection: A fungus that is a natural resident of the intestines and vagina, Candida
creates a problem only when it overpopulates, causing an irritating discharge that leads to
swelling, itching and general discomfort. Natural plant extracts and herbs if used properly can
be quite effective in the treatment of such infections. Antibiotics are especially notorious in
promoting vaginal yeast infections, which are caused by Candida as they kill other microflora
allowing Candida to overpopulate.
Trichomoniasis: This is another common vaginal infection which is caused by the
microorganism Trichomoniasis vaginalis. It produces a thick, yellowish discharge, often resulting
in swollen, inflamed genitals. Trichomoniasis is rarely serious, but can be harder to get rid of
than a yeast infection. It also tends to be much more unpleasant, with more intense burning
and itching.
Chlamydia injection: One infection that a person can have without experiencing any symptoms
is chlamydia (men can get this too, but it is more common among women). If untreated, it can
lead to sterility. Though rare about a decade ago, it now heads the list of sexually transmitted
diseases with an estimated four million new infections occurring every year worldwide.
Chlamydia can be passed on to a baby during childbirth and is one of the leading causes of
blindness in the world. Most cases of Pelvic Inflammatory Diesease (PID) are the result of
chlamydia, with the sexually transmitted disease gonorrhea a close second. Gonorrhea was on
the wane in the 1970s, thanks to antibiotics, but has come back during the last decade because
it has developed new, drug-resistant strains that the old antibiotics cannot kill. As new, stronger
drugs are created, tougher strains of gonorrhea are appearing.
Herbs useful in douching
Some of the herbs found to be useful in douching are lavender, tea tree, garlic and berberine
(found in goldenseal, barberry and Oregon grape root) as these kill harmful microorganisms,
including yeast and trichomonads. One study showed that tea tree was especially good at
ridding women of a variety of different vaginal infections. Slippery elm is soothing, and Uva ursi
is a disinfectant and astringent that dries the discharge caused by an infection
( h t t p : / / l i b r a r y . m o t h e r n a t u r e . c o m / l / h e r b s - f o r - h e a / t h - a n ~ a l -
infections 1094.html).
A commercially available herbal douche comprises extracts of six herbs in apple cider, which
help restore normal pH of the vagina, have a soothing effect and kill off a variety of undesirable
organisms including the ones present during vaginal infections. Composition of the same along
with function of each ingredient is given below:
1. Marshmallow (Althea organic)- soothes and protects irritated mucous membranes
2. Yarrow- local immune support, antiviral, squamous cell repair
3. Oregon grape- contains berberine which has antibacterial, anti-yeast, and immune
enhancing effects on epithelial mucus membranes found in vagina. Antimicrobial
activity against Candida albicans, coli, Staphylococcus aureus, and others.
4. Oregano (organic)- antibacterial and anti-candida with minimal effect on good flora.
Healing to damaged skin cells.
5. Old man's beard (Usnea)- local immune support
6. Calendula (organic)- reduces inflammation, wound healing, and antiseptic.^
Thymus essential oil
7. Apple Cider Vinegar (organic)- normalizes vaginal pH and soothes irritations from yeast
or other imbalances.
During use, the composition is shaken well and 1 Tablespoon of the concentrate is added to 6
oz of warm water. The indicated dose of Herbal Douche (or Arden's Powder) is inserted into a
small douche bag, filled with 60z. warm water and gently squeezed to expel air. Holding
squeezed bag, the pipe is inserted into the vagina and squeezed until contents are empty. Bag
is to be squeezed gently, without too much pressure. Dosage is not to be exceeded and it is not
be used more than 2 times per day or for more than 10 days.
Two other herbal based vaginal douche compositions which are disclosed in prior art are as
below: (http://voices.yahoo.com/article/120952/natural-herbal-douches-safe-effe~ive-not-
165193.html)
Douche for Vaginitis Relief:
10 drops essential oil of tea tree or X cup apple cider vinegar are added to 2 quarts of luke
warm water. The ingredients are combined in a 2 quart douche bag and used as per standard
douching procedure. The douche is good for external itching and burning and cleans excess
vaginal discharge. It is not to be used for more than 1-2 times per week.
Freshening Douche:
2 tablespoons peppermint, rosemary or yarrow are taken and added to 2 quarts water which
has been boiled and removed from heat. After adding the herbs, container is covered and
steeped for 2 hours. It is then strained and poured into a douche bag and used for douching.
The freshening douche is a good general cleanser and is not to be used more than once per
week.
Some other herbal remedies for the treatment of vaginal infections have also been disclosed
in the prior art (http://www.always-health.com/herbalremedies~vaginal~yeast.html) and same
are described below:
Use of herbs for treating vaginal yeast infection in women is an easy and painless way to get rid
of this bacterial disease before it causes further problems. Yeast infection in women mostly
takes place in vagina by a fungus called Candida albicans. Yeast is tiny organisms that normally
live in small numbers on the skin and inside the vagina. The acidic environment of the vagina
helps keep yeast from growing. However, the acidic balance of the vagina can be changed by
periods, pregnancy, diabetes, some antibiotics, birth control pills and steroids as well as
moisture and irritation. However, with use of proper herbal remedies, it is possible to control
this infection without taking any high potency tablets. There are many herbs which help in
treatment of vaginal yeast infection. These herbal remedies work best when taken daily over a
period of time.
Aloe Vera: Its juice and gel help the body in killing the yeast infection cells. The gel is applied
topically while the juice is taken internally. This herb is an anti-inflammatory, laxative and
immune stimulant. It contains amino acids, calcium, folate, iron, magnesium, phosphorous,
potassium and zinc; as well as vitamin A, C, and E.
Garlic: Garlic has antibacterial and antimicrobial properties which make it useful in treating
bladder and kidney infections, yeast infections, strep throats and ear infections. It is an
effective remedy against bacterial, fungal, viral and parasitic infections and Candida albicans,
the bacteria that cause yeast infection in women.
Garlic suppository: It is a quick to make, easy to apply and very effective remedy for treating
vaginal yeast infection. Due to its healing properties, garlic suppositories are a favorite remedy
of many women. Carefully peel a clove of garlic. Wrap a piece of thin gauze around the garlic,
fold the gauze in half and twist into a tail. It will look vaguely like a homemade tampon with a
tail, Insert the garlic suppository well inside the vaginal cavity. For easier insertion, a small
amount of oil can be rubbed on the end of the suppository. A fresh suppository should be
6
inserted every three to five hours removing the old one. Repeat for three to five days until the
infection completely is gone.
Cinnamon: Cinnamon is a powerful digestive aid. It is very beneficial for stopping uterine
bleeding and preventing heart attack. It is effectively used for fibroids, indigestion, liver cancer,
peptic ulcer and yeast infections in women. The bark is used medicinally as an oil or tea.
Echinacea augustifolia, Echinacea purpurea: This plant is native to Northern America used
extensively by Great Plains Indian tribes. One of the most common uses of this herb is immune
system stimulation and the prevention of infections. It appears to have antiviral properties due
to the stimulation of interferon-like effects.
Anti-yeast tea: Take 2 parts Sage, 2 parts mullein, 2 parts raspberry leaf and 1/4 part
goldenseal. Use four to six tablespoons of herb mixture as per quart of water. Add herbs to cold
water and bring to a simmer over low heat keeping pot covered. Remove from heat
immediately and let seep twenty minutes and then strain. This tea will be quite bitter, so you
may wish to mix it with cranberry juice. To cure vaginal yeast infection, drink three cups of the
tea between meals or half hour before eating each day.
Herbal remedies are a very good way of treating ailments. Herbs are not only inexpensive and
effective, they are also easily available and easy to prepare. Using a variety of herbs combined
with healthy food, exercise, fresh air and sound sleep make together a perfectly healthy life
plan.
Disadvantages of Douching :
Vaginal infections (bacterial vaginosis): Douching upsets the natural balance of bacteria in the
vagina (called vaginal flora), making the environment more favorable for the growth of bacteria
that cause infection. Studies have found that women who stopped douching were less likely to
have bacterial vaginosis. Having bacterial vaginosis can increase the risk of preterm labor and
endometriosis.
Pelvic inflammatory disease (PID): PID is an infection of the uterus, fallopian tubes, and/or
ovaries. Research has found that women who douche have a 73% higher risk of getting PID.
Pregnancy complications: Women who douche more than once a week have more difficulty
getting pregnant than those who don't douche. Douching also increases the risk of ectopic
pregnancy by as much as 76%. With an ectopic pregnancy, the embryo implants outside the
uterus. The more a woman douches, the more her risk of ectopic pregnancy rises. Douching
during pregnancy has been linked to increased risk of preterm birth.
Cervical cancer: Douching at least once a week has been linked to an increased chance of
developing cervical cancer,
According to health experts, including those at the American College of Obstetricians and
Gynecologists (ACOG), douching should be avoided. Having some vaginal odor is normal.
however, in case of a very strong odor, one should contact the doctor because it could be a sign
of infection. The acidity of the vagina controls bacteria in a natural and effective manner.
Simply washing the vagina with warm water and mild soap is enough to keep clean.
Thus, douching as a practice remains a debatable subject. However, based on practical
observations of the inventor and review of prior art subject matter, two clear factors emerge:
Firstly, composition of the douche makes a significant difference upon its efficacy in
management of vaginal infections. Secondly, the manner in which the douche is used affects
efficacy of the process and also reduces unwanted side-effects. The frequency of douching i.e.
whether daily or weekly etc. and also the correct manner of not using too much force when
flushing the vagina with the 'douche liquid' affects the results.
Prior art patents related to herbal compositions for use as a vaginal douche
Patents exist in the prior art which describe the use of various herbal ingredients for use as
vaginal douches.
US Patent number 7,687,078 issued March 2010 describes a composition for use as a vaginal
douche, comprising salts of sodium, potassium and magnesium. It does not relate to a herbal
composition as in present invention.
US Patent Application no. US 2005/0233011 A1 describes methods for making herbal materials
into medicinally and pharmaceutically acceptable forms including those for use a vaginal
douche. The invention relates to Hydrstatis canandensis (Goldenseal) and relates to a process
which allows the precise standardization of at least two marker compounds viz. berberine and
hydrastine in both the hydro-alcoholic tincture and solid extracts in the processing of
goldenseal materials, to produce extracts which qualify as pharmaceutical grade compositions.
US Patent Application no. US 2008j0038196 A1 is a continuation of the above patent
application in which standardization of botanical products utilizing biological activity as a
marker is described.
US Patent number 5,292,532 issued March, 1994 describes a vaginal douche composition
based on chemically synthesized, pharmaceutically active compounds. It does not relate to a
herbal composition as in present invention.
US Patent numbers 3,219,525 and 3,584,119 (issued November, 1965 and June, 1971
respectively) disclose vaginal douche compositions comprising chemically synthesized,
pharmaceutically active compounds in combination with foaming agents to enhance the
'contact time' of the active ingredients with the inner vaginal surface, resulting in better
efficacy. They do not relate to herbal composition for use as vaginal douche, as in present
invention.
US Patent Application no. US 2009/0105668 A1 filed Oct 20, 2008 discloses a feminine vaginal
douche for tightening a vaginal orifice. It comprises chemical ingredients and does not have any
herbal ingredients as in present composition.
Search of other international databases did not reveal any such composition as disclosed in the
present invention. Search of patents filed and granted in India, including published patent
applications did not reveal any such composition as disclosed in the present invention.
OBJECT OF THE INVENTION
It is an object of the invention to disclose a composition based on herbal extracts for use as a
vaginal douche.
A further object of the invention is to disclose a herbal vaginal douche composition which is
safe and does not suffer from the limitations of prior art compositions based on synthetic
compounds, which upset the natural micro flora of the vaginal region.
One more object of the invention is to disclose a herbal vaginal douche composition which is
effective in maintaining vaginal hygiene.
A still further object of the invention is to disclose a herbal vaginal douche composition which is
effective in the cure and management of vaginal infections.
DETAILED DESCRIPTION OF THE INVENTION
After considerable degree of research and evaluation, the inventor of the present invention
developed a novel composition based on herbal extracts, for use as a safe and effective vaginal
douche. The composition apart from being effective against the microbes causing vaginal
infections, was also found to be particularly effective against E.coli strain causing uterine tract
infection or UTI. Uropathogenic E. coli (UPEC) is responsible for approximately 90% of urinary
tract infections (UTI) seen in individuals with ordinary anatomy. In ascending infections, fecal
bacteria colonize the urethra and spread up the urinary tract to the bladder as well as to the
kidneys (causing pyelonephritis) or the prostate in males. Because women have a shorter
urethra than men, they are 14 times more likely to suffer from an ascending UTI.
10
A number of treatments for the same are proposed in traditional medicine as well as modern
medicine. While traditional treatments suffer from the limitation of results from patient to
patient, modern treatments based on antibiotics are prohibitively expensive. Antibiotics which
may be used to treat E. coli infection include amoxicillin, as well as other semisynthetic
penicillins, many cephalosporins, carbapenems, aztreonam, trimethoprim-sulfamethoxazole,
ciprofloxacin, nitrofurantoin and the aminoglycosides.
Also, after a period of time, antibiotics may become ineffective owing to development of
resistant strains, due to which further physiological complications may occur. In fact antibiotic
resistance is a growing problem. Some of this is due to overuse of antibiotics in humans, but
some of it is probably due to the use of antibiotics as growth promoters in animal feeds. A
study published in the journal Science in August 2007 found the rate of adaptative mutations in
E. coli is "on the order of 10-5 per genome per generation, which is 1,000 times as high as
previous estimates," a finding which may have significance for the study and management of
bacterial antibiotic resistance.
Antibiotic-resistant E. coli may also pass on the genes responsible for antibiotic resistance to
other species of bacteria, such as Staphylococcus aureus, through a process called horizontal
gene transfer. E. coli bacteria often carry multiple drug-resistance plasmids, and under stress,
readily transfer those plasmids to other species. Indeed, E. coli is a frequent member of
biofilms, where many species of bacteria exist in close proximity to each other. This mixing of
species allows E. coli strains that are piliated to accept and transfer plasmids from and to other
bacteria. Thus, E. coli and the other enterobacteria are important reservoirs of transferable
antibiotic resistance.
The herbal composition of the present invention owing to its polyherbal nature does not allow
the bacteria to develop resistance and unlike antibiotics does not suffer from any side-effects. It
thus offers the dual benefits of safety and efficacy for users. The composition is made up of
water extracts of only five herbs viz. Ficus religiosa bark (2%); Ficus bengalensis bark (2%);
Hamamelis virginiana bark (2%) and Aloe Vera leaf pulp (5%) and Melaleuca alternifolia leaf oil
(0.2%). The composition is given below in Table 1:
Table 1: Composition of the Vaginal Douche
Quantity
(%I
13%)
optimally
2.0%
1-5%,
optimally
2.0%
1-5%,
optimally
2.0%
2-10%)
optimally
5.0%
0.1-1%
optimally
0.2%
Part used
Bark
Bark
Bark
Leaf Pulp
Leaves
Botanical
name
Ficus
religiosa
Ficus
bengalensis
Hamamelis
virginiana
Aloe vera
Melaleuca
alternifolia
No.
1.
2.
3.
4.
5.
ingredients
Water extract of Peepal bark
Water extract of Bargad bark
Water extract of Witch Hazel
bark
Water extract of leaf pulp of
Ghrit kumari
Tea Tree Oil extracted from
leaves
Table 2: Physiological roles of ingredients of the Vaginal Douche
I I (antihaemorrhagic properties), Vranghna
No.
1.
Ingredient Part Physiological role
Ficus religiosa
2.
3.
I I Pulp I inflammatory, moisturizes & nourishes I
used
Bark
Ficus bengalensis
(Bargad)
4.
Yoni shodhak (uterus toner), Stambhak
Hamamelis
virginiana (Witch
Hazel)
alternifolia
Bark
Aloe vera
5.
I I I I
Astringent medicines cause shrinkage of mucous membranes or exposed tissues and are
Yoni rog nasak (destroys infections of
uterus), pradar har (Leuchorrea curative
properties), Astringent *
Bark
often used internally to check discharge of blood serum or mucous secretions. This can
Astringent *
Leaf
Melaleuca
happen with a sore throat, hemorrhages, diarrhea, or with peptic ulcers.
Helps to stimulate cell renewal, anti-
Example 1: Method of Preparation of composition of present invention
Leaves
1. Clean and sanitize all the working area and equipment as per standard operating
the skin.
Antiseptic, Antibacterial and Antifungal
procedure.
2. Fit the manufacturing tank with homogenizer and add 250 liters of water in the tank.
3. Dissolve KATHONE CG (1 Ltr) in about 10 Liters water and add to the manufacturing tank
and mix. KATHONTM CG is a safe, effective and globally approved preservative for Rinse-
Off products.
4. Dissolve the Peepal extract (20kg) in water and pour into the tank during continuous
stirring.
5. Dissolve the Bargad extract (20kg) in water and pour into the tank during continuous
stirring.
6. Dissolve the Witch Hazel extract (20kg) in water and pour into the tank during continuous
stirring.
7. Dissolve the Aloe Vera Extract (50kg) in water and pour into the tank during continuous
stirring.
8. Dissolve BHA(O.lkg), BHT(O.lkg) and Tea Tree Oil (2kg) in Tween 20 (70 Ltrs) and mix and
add Propylene Glycol (20kg) after mixing with glycerin (20kg) and transfer the solution in
the manufacturing tank with continuous stirring for homogeneous mixing.
9. Adjust the pH (5.5) of the solution by using Lactic Acid as desired.
10. Dissolve Triclosan (2kg) in water and pour into the tank during continuous stirring.
11. Complete the volume of the tank 1000 Ltrs and mix well for proper mixing. Filter through
filter press using 20 micron filter pad and transfer the solution in storage tank.
12. This is the final formulation which can be packed into suitable 'packaging containers' for
use as a vaginal douche.
TEST SPECIFICATIONS OF THE FINAL PRODUCT
Anti-microbial activity of the composition:
The composition which is a polyherbal extract shows excellent anti-microbial activity. In fact, it
showed extremely good activity against antibiotic resistant strains obtained from patients
suffering from UTI (urinary tract infection). Culture and Sensitivity test of urine from patient
suffering from urinary tract infection revealed growth of antibiotic resistant bacteria of
Klebsiella sp. (ESBL) and complete lack of sensitivity of the bacteria to a wide range of
antibiotics. However, the polyherbal composition of the present invention was found to be quite
effective against the antibiotic resistant bacterial, as shown in Table 1 below:
Resistant -
Partially sensitive -+
Sensitive +
Clear Liquid
Light Yellowish
Characteristic
5.5
0.90 -1.20
1.
2.
3.
4.
5.
Appearance
Colour
Odour
pH
Weight per ml
Table 1
ANTIBIOTIC TESTED
3. GEMIFLOXACM
4. MEROPENEM
7. CEFOPARA+SULBACT
8. CEETAZIDIME
9. CEFOTAXIME
10, CEFUROXIME
1 1 .CWI+OKAMPHENICOL
12. CEFJPME
13. CLINDANYCM
14. COLJSTlN
i 5. GATIFLOXACIN
16. GGWAMYCIN
4 17. [MIPENEM
18. LEVOFLOXACIN
I 9. LLNEZO LID
20. PIPERAcTAZO,
2 i .NETLIMYCn(lr
SENSITIVITY
22.Pr"BKFLOXACIN -
4 23. Nf'I"KOFURANT0IN
24 TiGECYCLINE 0 -
25.0FtOXACW -
26.POLYMIXJN-D - -
27. Polyherbal extract of present invention

Claim:
1. A composition of herbal extracts for use as a vaginal douche wherein the same
comprises an aqueous mixture of :
i. Water extract of Bark of Peepal (Ficus religiosa) : 1-5%, optimally 2.0 %
ii. Water extract of bark of Bargad (Ficus bengalensis) : 1-5%, optimally 2.0 %
iii. Water extract of bark of Witch Hazel (Hamamelis virginiana): 1-5%, optimally
2.0 %
iv. Water extract of leaf pulp of Ghrit kumari (Aloe Vera) : 2-10% , optimally
5.0 %
v. Tea Tree Oil (Melaleuca alternifolia) from leaves : 0.1-I%, optimally 0.2%
to which adequate amount of stabilizers and excipients are added to stabilize the
solution.
2. The composition of claim 1 wherein the stabilizers are 5-chloro-2-methyl-4-isothiazolin-
3-one; 2-methyl-4-isothiazolin-3-one, BHA, BHT or any other known pharmaceutical
stabilizer.
3. The composition of claim 1 wherein the excipients are propylene glycol and glycerin and
lactic acid.
4. The composition of claim 1 wherein the same shows biological activity against antibiotic
resistant bacteria.