FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
[See section 10, Rule 13]
HERBAL PREPARATION FOR
CONTROLLING AND REDUCING HAIR FALL;
MARICO LTD., A COMPANY
INCORPORATED UNDER THE
COMPANIES ACT, 1956, HAVING ITS REGISTERED OFFICE AT MARKS, 23-C MAHAL INDUSTRIAL ESTATE, OPP. ANDHRA BANK, MIDC, MAHAKALI CAVES ROAD, ANDHERI (EAST), MUMBAI - 400 093, MAHARASHTRA, INDIA
THE FOLLOWING SPECIFICATION
PARTICULARLY DESCRIBES THE
INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED.

FIELD OF THE INVENTION
The present invention relates to a formulation for reducing hair fall, more particularly the invention relates to a herbal formulation for reducing hair fall and a method of preparing the same.
DESCRIPTION OF THE BACKGROUND ART
It is normal to loose few strands of hair daily as part of the hair renewal process but at some point of time most of the people suffer from excessive hair loss. Hair loss of this type can affect men, women and children. The medical term for hair loss is "alopecia". The alternative names are hair fall, baldness, loss of hair, etc. There are different types of hair loss based on the type and cause. The most common type is androgenic alopecia also know as male pattern baldness (when it occurs in men) or female pattern baldness {when it occurs in women). Other types are usually temporary and may be a symptom of serious illness, skin infection, stress, use of certain drugs, thyroid diseases, hormonal, childbirth, birth control pills, trichotillomania or hair pulling, hair styling treatments, hair braids/weaves etc. the hair loss halts once the underlying cause has been identified and treated.
There are various types of treatment available for hair loss including medicinal or ayurvedic treatment. In ayurvedic hair loss treatment different things like herbs,

yoga, meditation, yoga, balanced diet, and oil massage are combined to give a positive result.
WO2006061847 The above document claims a herbal dye composition comprising extracts of various natural materials including Lawsonia inermis, Trigonella foenum-graecum and Emblica officinalis for preventing hair from falling out and also helping in re-growth of the hair.
KR801164 The above document discloses a composition comprising a mixture of extract of henna, copper-peptide and pyrrolidinyl diaminopyrimidine oxide for preventing hair loss and promoting hair growth.
W01997013492 The above document discloses a strengthening agent containing trigonelline or trigonellic acid, preferably from an extract of the seeds of fenugreek (Trigonella foenum graecum) for stimulating and/or revitalizing the growth of hair.
FR2854066 The above document discloses a topical cosmetic composition for stimulating growth and combating loss of hair contains synergistic mixture of Ginkgo biloba, mucopolysaccharide, Swertia, group B vitamin, aloe vera and proline.

KR0691791 The above document discloses a shampoo and a hair tonic comprising various ingredients including Cyperus rotundus for preventing alopecia and growing hair.
Common approaches have been the use of single/ combination of herbal ingredients to achieve the same. The concentration of these herbs is usually very low leading to less effective product.
SUMMARY OF THE INVENTION
It is an object of the invention to control hair loss by providing a herbal formulation.
It is another object of the invention to reduce hair fall or hair loss by providing a herbal formulation.
According to an aspect of the present invention, a herbal formulation for reducing and controlling hairfall comprises of herbs belonging to the family Phyllanthaceae, Lythraceae, Fabaceae, Xanthorrhoeaceae and Cyperaceae. The herbal formulation is synergistic in nature thereby effectively controlling and reducing hairfall.

Another aspect of the invention discloses a process for preparing a herbal formulation comprising of herbs belonging to the family of Phyilanthaceae, Lythraceae, Fabaceae, Xanthorrhoeaceae and Cyperaceae.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
According to an embodiment of the invention, a herbal formulation or preparation for reducing and controlling hair fall comprises of herbs belonging to the family Phyilanthaceae, Lythraceae, Fabaceae, Xanthorrhoeaceae and Cyperaceae. The herbal formulation exhibits synergy and is effective in not only controlling but also reducing the hairfall. The herb belonging to the family of Phyilanthaceae is amla. The herb belonging to the family of Lythraceae is henna. The herb belonging to the family of Fabaceae is fenugreek. The herb belonging to the family of Xanthorrhoeaceae is aloe. The herb belonging to the family of Cyperaceae is nagarmotha. The formulation is a synergistic blend of amla, henna, fenugreek, aloe and nagarmotha.
The concentration of the herb present in the formulation belonging to the family of Phyilanthaceae is preferably amla. The concentration of amla is 5-15%.
The concentration of the herb present in the formulation belonging to the family of Lythraceae is preferably henna. The concentration of henna is 0.5-5%.

The concentration of the herb present in the formufation belonging to the family of Fabaceae is preferably fenugreek. The concentration of fenugreek is 0.2-3%.
The concentration of the herb present in the formulation belonging to the family of Xanthorrhoeaceae is preferably aloe. The concentration of aloe is 2-10%.
The concentration of the herb present in the formulation belonging to the family
0.5-5%.
The total concentration of the herbs that is amla, henna, fenugreek, aloe and nagarmotha is 25%. The combination and the concentration of the herbs make this invention unique from those currently existing.
The formulation further comprises of excipients like antioxidants, perfume and preservatives. BHT/ BHA- 0.01-0.3%, Perfume: 0.1-1.5%. Propyl paraben- 0.01-0.2%. The base oil can be a mixture of oils like coconut, sesame, sunflower, Rice bran, Liquid paraffin etc.
The present formulation can be formulated in oil form using any oil as a base. It can also be formulated as a cream, lotion, or in any other form.

It is to be noted that the present invention is most preferably carried out with the extracts of the herbs that are available in the market.
Another embodiment of the present invention relates to a process for preparing the herbal formulation comprising of amla, henna, fenugreek, aloe and nagarmotha. The process comprises the following steps: Pre-Preparatory Steps
1. Fenugreek seeds were germinated by soaking the seeds in water for 3-4 hours. The soaked seeds were tied in a cotton cloth for 24 hours.
2. Amla and nagarmotha were grinded and the fine powder was removed in a sieve. The coarse powder was used for further steps.
3. Aloevera leaves were sliced into small pieces.
4. Henna powder was used. Preparation of Concentrate

Ingredients For 1 KL
Phase 1
Amla 125
Aloe vera 62.5
Nagarmotha 25
Henna 25
Fenugreek 12.5
Phase 2 Water 4000
Phase 3 CNO 1000
Step-1 (Decoction)
All the above mentioned herbs were added in water and boiled in a vessel to
reduce the volume to 500 I. During boiling, the solution was stirred with an iron

spatula. Just before the end of the process a filter mesh was placed in the middle of the vessel so that the bigger herb particles remained outside the boundary of the mesh and only decoction remained inside the mesh.
Step-2
250 litres of coconut oil was taken in another vessel and 500 I of the decoction of
step 1 was added slowly under stirring. The mixture was heated at 80-85° C until the water evaporated. During processing the oil foams and the foaming stopped when the process was completed. This step indicated the completion of the process. As the herbs lose all its water content, it started floating on the oil as dark particles. It was filtered with the help of an iron mesh.
Filtration
The oil was cooled to room temp and filtered in a sparkler filter.
Dilution:
In 250 litres of CNO obtained in step 2, 750 litres of CNO was further added.
The source and geographical origin of the components of the formulation are given in the following table:

Component Source Geographical Origin
Amla Emblica officinalis Mumbai
Henna Lawsonia inermis Mumbai
Fenugreek Trigonella foenum-graecum Mumbai
Aloe Aloe barbadensis Mumbai

Nagarmotha
Cyperus scariosus Mumbai
It is to be noted that the herbs are commonly available to the public.
SYNERGY OF THE HERBAL FORMULATION
The herbal formulation as encompassed by the present invention is a synergistic combination of amla, henna, fenugreek, aloe and nagarmotha. All the individual components act in synergy with each other to give beneficial results, which is much more enhanced when compared with the individual components. The synergy of the formulation is explicated by means of a study that was carried out to establish the enhanced effect of the formulation.
A clinical study to evaluate the efficacy of hair oil comprising of amla, henna, fenugreek, aloe and nagarmotha in the management of hair fall was carried out to establish an effective remedy for hair fail, a highly stressing disease in today's era. The main objective of the study was to compare the results of various combinations of amla, henna, fenugreek, aloe and nagarmotha with a mixture of the herbal formulation of the present invention. The following formulations or test products were used for the study:
1. Formulation A - Oil comprising of amla, henna, fenugreek, aloe and
nagarmotha
2. Formulation B - Oil comprising of henna, fenugreek and nagarmotha

3. Formulation C - Oil comprising of amla and aloe
The study was conducted on women between the ages 20-40 years, who complained of hair fall. The trial was designed as a randomized and double blind trial. Total 120 patients were selected for this study. These patients were divided in three matched panels of 40 patients. Each group was then randomly assigned to 1 of the 3 of the test products. Duration of the treatment was for 6 weeks followed by 4 weeks of regression. The dose was 10ml daily application of the hair oils on the scalp. The preferable time of application of the hair oil was early morning before bath and/or after dinner before going to bed. Preferably, the oil used was warmed before application on the scalp. The hair was washed with herbal shampoo the next morning and oil was washed away gently.
Results
The clinical observations of 120 patients in 3 groups in this study were noted meticulously in each visit for 5 visits. Following were the results obtained:

Group Initial 2 Weeks 4 Weeks 6 Weeks 4 Weeks
Scores Treatment Treatment Treatment Regression
Formulation 2.33 1.04 0.39 0.08 0.15
A
Formulation 2.35 0.96 0.64 0.37 1.27
B
Formulation 2.36 1.23 0.43 0.31 1.34
C

According to the scores decided at the initiation of study this table shows the score chart noted at the time of each visit. A mean value for all patients in the group was calculated after the end of all visits. This average hair fall score indicates the effect of the oils observed in each group as specified.
• Formulation A shows initial score of 2.33 and the score at the 4 weeks regression is 0.15
• Formulation B shows initial score of 2.35 and the score at the 4 weeks regression is 1.27
• Formulation C shows initial score of 2.36 and the score at the 4 weeks regression is 1.34
This calculated score illustration encompasses the overall effect observed in the 3 groups. The lowest score at the 4 weeks regression is indicative of the efficacy of the product. As can be inferred from the above results, Formulation A comprising of amla, henna, fenugreek, aloe and nagarmotha shows the lowest score of 0.15 thus indicative of the highest rate of reduction in hair fall and establishing the synergy in between the different components of the formulation.
The composition is effective for reduction in dandruff and flaking, reduction in itching & inflammation, increasing hair length and reduction in hair graying.
While the present invention has been described herein with respect to the various exemplary embodiments, it will be apparent to one of the ordinary skill in the art that many modifications, improvements and sub combinations of the

various embodiments, adaptations and variations can be made to the invention
without departing from the spirit and the scope thereof.
The following examples illustrate the invention, but are not limiting thereof.
Example A:

Ingredients For 1 KL
Phase 1
Amla 125
Aloe vera 62.5
Nagarmotha 25
Henna 25
Fenugreek 12.5
Phase 2 Water 4000
Phase 3 CNO 1000
Example B:

Ingredients For 1 KL
Phase 1
Nagarmotha 25
Henna 25
Fenugreek 12.5
Phase 2 Water 4000
Phase 3 CNO 1000
Example C:

Ingredients For 1 KL
Phase 1
Amla 125
Aloe vera 62.5

Phase 2 Water 4000
Phase 3 CNO 1000

WE CLAIM:
1. A formulation for controlling hairfall, wherein the formulation comprises of herbs belonging to the family of Phyllanthaceae, Lythraceae, Fabaceae, Xanthorrhoeaceae and Cyperaceae, wherein the formulation is synergistic and is effective in controlling hairfall
2. The formulation as claimed in claim 1 wherein the formulation comprises of extracts of Phyllanthaceae, Lythraceae, Fabaceae, Xanthorrhoeaceae and Cyperaceae.
3. The formulation as claimed in claim 1 wherein the herb belonging to the family of Phyllanthaceae is amla.
4. The formulation as claimed in claim 1 wherein the herb belonging to the family of Lythraceae is henna.
5. The formulation as claimed in claim 1 wherein the herb belonging to the family of Fabaceae is fenugreek.
6. The formulation as claimed in claim 1 wherein the herb belonging to the family of Xanthorrhoeaceae is aloe.
7. The formulation as claimed in claim 1 wherein the herb belonging to the family of Cyperaceae is nagarmotha.

8. The formulation as claimed in claim 1 wherein the formulation is a blend of amla, henna, fenugreek, aloe and nagarmotha.
9. The formulation as claimed in claim 3 wherein the concentration of amla is 5-15%.
10. The formulation as claimed in claim 4 wherein the concentration of henna is 0.5-5%.
11. The formulation as claimed in claim 5 wherein the concentration of fenugreek is 0.2-3%.
12.The formulation as claimed in claim 6 wherein the concentration of aloe is 2-10%.
13. The formulation as claimed in claim 7 wherein the concentration of nagarmotha is 0.5-5%.
14. The formulation as claimed in claim 1 further comprising additional excipients.
15. The formulation as claimed in claim 1 wherein the formulation is in the form of oil.

16. A process of preparing the formulation comprising of herbs belonging to the family of Phyllanthaceae, Lythraceae, Fabaceae, Xanthorrhoeaceae and Cyperaceae, the process comprising the steps of: pre-preparation: germinating the fenugreek seeds, grinding nagarmotha and amla and slicing aloe leaves; using henna;
decoction making- boiling the herbs in water and evaporating the water in the presence of oil; filtration and dilution of the formulation obtained to desired concentration.