FIELD OF THE INVENTION
The present invention pertains to the field of pharmaceutical formulations. More specifically it pertains to a novel topical composition for treatment of alopecia and hair related disorders.
BACKGROUND OF THE INVENTION
Alopecia is a condition in which hair is lost from some or all areas of the body of human usually from the scalp. It causes bald spots on the scalp, for which it is also called as spot baldness. It also occurs in people who are apparently healthy and have no skin disorder. It can occur in any stage of life.
Causes:
Alopecia is a non-communicable and non-contagious disease. The condition is thought to be an autoimmune disorder in which the body attacks its own hair follicles and suppresses or stops hair growth. There is evidence that T cell lymphocytes cluster around these follicles, causing inflammation and subsequent hair loss. An unknown environmental trigger such as emotional stress or a pathogen is thought to combine with hereditary factors to cause the condition.
Prognosis:
Effects of alopecia are mainly psychological (loss of self image due to hair loss). Patients suffering from alopecia also tend to have a slightly higher incidence of asthma, allergies, atopic dermal ailments and hypothyroidism. Loss of hair raises scalp burns more easily in the sun. Loss of nasal hair increases severity of hay fever and similar allergic conditions. Patients may also have aberrant nail formation because keratin forms both hair and nails. Alopecia can certainly be the cause of psychological stress because hair loss can lead to significant appearance changes, individuals may experience social phobia, anxiety, and depression.
Types of Alopecia:
There are several types of alopecia found in case of human beings which are listed below.
• Diffuse alopecia: In this case hair loss occurs more diffusely over the whole scalp.
• Androgenic alopecia: This condition is known as male pattern baldness. In this
case loss of hair takes place specially in case of males.
• Alopecia monolocularis: In this case baldness occurs in only one spot and may occur anywhere in the head.
• Alopecia multilocularis: In this case hair loss occurs from multiple areas of the body.
• Alopecia barbae: This affects mainly the portion of beard.
• Alopecia totalis : In this case loss of total hairs takes place.
• Alopecia universalis: In this case loss of mainly pubic hair along with other hair takes place.
Prior art methods/compositions for treating Alopecia:
There are various treatments available commercially for Alopecia.
• Alopecia is treated with clobetasol or fluocinonide, steroid injections or cream in case of severe conditions of hair loss. Steroid injections are commonly used in sites where there are small areas of hair loss on the head or especially where eyebrow hair has been lost.
• Some other medications used for treatment of alopecia are minoxidil, irritants (anthralin or topical coal tar) and topical immunotherapy involving use of cyclosporine.
• For small patches on the beard or head it is possible to suppress with topical tacrolimus ointment ( a topical drug used for skin related disorders) such as protopic ( brand name of a topical drug commercially available).
• Initial stages may be kept from increasing by applying topical corticosteroids.
• A non-conventional treatment employs living leeches as a form of treatment
These approaches have certain limitations as follows:
1. Adverse effects : Oral corticosteroids decrease the hair loss but only for the period during which they are taken and these drugs have adverse side effects like dizziness, nausea, indigestion, increased appetite, weight gain, weakness or sleep disturbances. Treatment with tacrolimus ointment is recommended only for short periods of time due to adverse side effects
like burning and itching sensation over skin, headache, cough and burning eyes.
2. Lack of efficacy : Topical corticosteroids frequently fail to enter the skin deeply enough to affect the hair bulbs, which are the treatment target.
3. Leech therapy for treatment of hair loss: It is a technique in which medicinal living leeches are used to drain replanted or transplanted tissue engorged with venous blood. It is also used for re growth of lost hair. Banaras Hindu University is using leech therapy to cure diseases associated with ageing including paralysis, hair loss and osteo - arthritis. However this medication has a limitation that living leeches are used for the treatment and not all patients suffering from alopecia may feel comfortable with this therapy (AORN Volume 62, Issue 2, August 1995, Pages 175-184; Retina's Wisdom - A journal of life, health and cultural eccentricities : Ayurvedic Detox - Leeches help you live longer, 21 July, 2008)
Compositions commercially available in the market: A number of formulations are available in the market for treatment of hair fall, but none of them discloses the novel composition of the present invention. Some of the compositions are discussed below in table 1.
Table 1:

(Table Removed)
No formulation of hair oil used for the treatment of Alopecia which is commercially available as above discloses the novel composition of the present invention which comprises water and sesame oil extracts of Leech alongwith the herbs Celastrus paniculatus and Nyctanthes arbortristis. and shows remarkable results in preventing hair fall and also treatment of Alopecia.
PATENTS RELATED TO TREATMENT OF ALOPECIA AND HAIR FALL EXISTING IN PRIOR ART: Table 2:

OBJECTS OF THE INVENTION
The invention has the following objects:
1. To disclose a novel topical formulation possessing synergistic effect which has higher efficacy than the compositions existing in prior art for treatment of alopecia and hair loss .
2. To disclose a novel topical formulation which is easy to manufacture, cost-effective and safe for scalp.
3. To disclose the method of preparation of the formulation used for treatment of alopecia and hair loss.
SUMMARY OF THE INVENTION
The present invention provides a new topical synergistic formulation for treatment of alopecia and hair loss. The same is novel, cost effective, safe and efficacious. It provides faster growth of lost hair. After applying the formulation hair fall stops after one to two weeks and re-growth of lost hair takes place after about 90 - 120 days.
BRIEF DESCRIPTION OF THE DRAWINGS
Nil - No drawings are attached
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to a novel synergistic formulation for treatment of alopecia and hair loss which obviates the drawbacks of existing compositions viz. complexity, less efficacy, higher cost etc.
NOVELTY ASPECT OF THE INVENTION
The present invention discloses a novel formulation comprising extracts of dried Leech, dried seeds of Celastrus paniculatus . dried parts (leaf. bark, rind, root, branch, stem, fruits and flowers) of Nyctanthes arbortristis in sesame oil and water. It is a novel formulation having synergistic effect and high efficacy and the same has not been disclosed anywhere in the prior art to the best of inventor's knowledge.
INVENTIVE STEPS
The inventive step of the invention lies in developing a simple, inexpensive faster acting formulation for treatment of alopecia and hair care. This is achieved by extracting a mixture of dried leech, dried seeds of Celastrus puniculatus . dried parts (leaf, bark, rind, root, branch, stem, fruits and flowers) of Nyctunthes arbortristis in sesame oil in desired quantity along with water, which is nowhere disclosed in prior art methods. After considerable research efforts, the inventors developed the present natural composition which is quite efficacious in the treatment of alopecia and hair care.
INDUSTRIAL APPLICATION
The present invention can easily be manufactured on an Industrial scale as a pharmaceutical topical formulation for re growth of lost hair in case of alopecia and in preventing hair fall. It provides the consumer with an effective, gentle, more economical and safe product that can be easily stored and used as needed.
DETAILS OF THE INVENTION
Although the ingredients used together for the preparation of the novel formulation are individually known for their properties as described below for hair care, yet the combination of all these ingredients in synergistic combination for the novel composition is nowhere reported in prior art to the best of inventor's knowledge.
INGREDIENTS OF THE NOVEL COMPOSITION
1. Leech: Leeches are annelids comprising the subclass 1 lirudinea. The European Medical Leech {Hirudo medicinalis) have been used for clinical bloodletting for thousands of years. Medicinal Uses:
• Leeches are used for treatment of hair loss and helps in re growth of lost hair.
• Leeches are used for treating abscesses, painful joints, glaucoma. myasthenia, and to heal venous diseases and thrombosis.
• Medical leeches are used in plastic surgery, for improving brain
circulation and for curing infertility.
However, this methodology suffers from the limitation that commercial scale-up is difficult. Handling live leeches is not easy. In contrast, the present composition uses oil and water extracts of dried leeches which are easily available commercially in bulk.
2. Celastrus paniculatus: It is a large woody climber of family Celastraceae used in
ayurdevic medicine in India. It is generally found in warm and tropical regions.
Chemical Constituents: Seeds of Celastrus paniculatus contain 52.2 % thick
pungent and odorous oil. It also contains alkaloid and some acids (like Silestrin
and Peniculetin) of 5%. Oil contains a chemical known as criojot.
Medicinal Uses:
• It is used as a pain receptor.
• It is used as an excellent brain tonic and helps in improvement of mental skills.
• It helps in strengthening of nervous system.
• It acts as an appetite increaser.
• It is also useful in heart related and skin related disorders.
Its use in the present composition was found to be that of a stabilizer and masking the offensive odor of leech during extraction.
3. Nyctanthes arbortristis: It is a shrub or a small tree . It is a native to
southern Asia, from northern Pakistan and Nepal south through northern India and
southeast to Thailand. It is a very useful herb in India. Several parts like leaf,
bark, rind, root, branch, stem, fruits and flowers are used in the field of medicine.
Chemical Constituents:
• Leaves contain D-mannitol, ß-sitosterole, flavanol glycosides-astragaline. nicotiflorin, oleanolic acid, nyctanthic acid, tannic acid, ascorbic acid, methyl salicylate, an amorphous glycoside, an amorphous resin, trace of volatile oil. carotene, friedeline. lupeol, , mannitol. glucose . fructose, iridoid glycosides and benzoic acid.
• Flowers contain essential oil, nyctanthin, d-mannitol, tannin, glucose, carotenoid, glycosides Viz ß-monogentiobioside ester of α - crocetin
(or crocin-3), ß-monogentiobioside -ß-D monoglucoside ester of α-crocetin, ß-digentiobioside ester of α-crocetin (or crocin-1).
• Seeds contain arbortristoside A&B. glycerides of linoleic, oleic, lignoceric, stearic, palmitic and myristic acids, nyctanthic acid, 3-4 secotriterpene acid, A water soluble polysaccharide composed of D-glucose and D mannose.
• Bark contains glycosides and alkaloids.
• Stem contains glycoside-naringenin-4'-0-ß-glucapyranosyl-α-xylopyranoside and ß-sitosterol.
• Flower oil contains α-pinene, p-cymene, 1- hexanol methyl heptanone, phenyl acetaldehyde. 1-deconol and anisaldehyde.
• Plant contains 2,3,4.6-tetra-O-methyl-D-glucose, 2,3,6 tri-O-methyl-D-glucose, 2,3,6-tri-O-methyl-D-mannose, 2,3,-di-O-methyl-d-mannose, arbortristoside A,B,C and iridoid glycoside.
Medicinal Uses:
• It is also useful in treating baldness, scurvy and infefections of the scalp.
• The decoction of its seeds is used as a hair tonic. Washing hair daily with this tonic helps to get rid of dandruf and lice.
• It is also used to treat anxiety, restlessness, headaches, gastritis, hepatitis, diarrhea, vertigo (a type of dizziness) and dysmenorrhoea.
• It is useful in treatment of piles, gout, dry cough and gynecological
troubles.
• The leaves are used in ayurvedic medicine, to treat sciatica (A type of neuronal pain), arthritis, fevers, rheumatism and various painful conditions.
• It is also used in skin related troubles, especially ringworm, bronchitis and as an antidote for snakebites.
Its use in the present composition was to enhance the 'hair restoring' effect of the overall composition i.e. synergistic effect.
4. Sesame Oil: It is an edible vegetable oil derived from sesame seeds . Besides being used as a cooking oil in South India, it is often used as a flavor enhancer in Chinese. Korean and to a lesser extent Southeast Asian cuisine.
Chemical Constituents : It contains carbohydrates, proteins, fats, Vitamin C. Vitamin E. Vitamin K, calcium, iron, magnesium, phosphorous, potasium, sodium and some fatty acids like (palmitic, palmitoleic, stearic, oleic, linoleic, linolenic and eicosenoic ).
Medicinal Uses:
• It is used for hair and scalp massage and reduces the heat of the body and thus helps in preventing hair loss.
• Sesame oil is used in the manufacture of Ayurvedic drugs.
• It reduces high blood pressure.
• Various constituents present in the sesame oil have anti-oxidant and antidepressant properties and helps in release of stress and tension.
In the present composition, it was used for extraction of the active ingredients from leech and herbs and enhancing their penetration into skin..
Method of preparation of the composition is given in Example 1 below. Example 1 - PREPARATION OF 10 Kg OF HAIR OIL
For extracting 10 kg of the finished formulation in the form of oil, we require 21 kg of total weight of ingredients as per the following table. TABLE 3:

(Table Removed)
METHOD OF PREPARATION OF THE FORMULATION
Step 1: The required amount of dried leech is ground and dipped in desired quantity of sesame oil overnight (at least 24 hours).
Step 2: After that required amount of Celastrus paniculatus and Nyctanthes arhortristis
are ground and mixed with the above prepared composition.
Step 3: Then the prepared composition is heated slowly. After about ten minutes small
bubbles are formed in the composition. Care should be taken that the composition does
not over boil.
Step 5: Approximately one liter of water is added every half an hour into the composition
to prevent burning of the oil and also to maintain the medicinal properties of the herb.
Water also helps in extracting the water soluble ingredients of the composition.
Step 6: The entire process is carried out approximately for three to four hours.
Step 7: After that the composition is allowed to cool for another four to five hours and
filtered using a suitable filtering matrix such as muslin cloth.
Step 8: The final product so prepared is the composition and is ready to use.
The criticality of the novel formulation lies in being able to bring about synergistic effects which increase the efficacy of the preparation. This is a faster acting composition for treatment of alopecia which contains extracts of dried Leech, Celastrus paniculatus and, Nyctanthes arbortristi as active ingredients, sesame oil as penetration enhancer and water as a vehicle in which the active ingredients are extracted from the leech as well as herbs.
METHOD OF APPLYING THE NOVEL FORMULATION:
Appropriate quantity i. e. ½ - 1 teaspoon of the prepared formulation can be applied once daily by gently rubbing into the scalp or affected area preferably at night.
POSITIVE EFFECT OBTAINED BY USING THE FORMULATION:
The formulation has unusually fast action and provides quick growth of lost hair and also stops hair fall. After applying it regularly, hair fall stops after one to two weeks and re growth of lost hairs take place after about 90 - 120 days. Obviously, results vary from individual to individual and also geographical locations owing to change of water and air quality and also nutrition, which affects hair quality and growth characteristics.
In the above detailed description of the invention various ingredients, their optimum concentration and also mode of action has been disclosed. Embodiments of the invention involving variations in the composition and also concentrations of the ingredients can easily be carried out once the basic concept is understood and hence should be regarded as within the scope of the present disclosure.

I CLAIM
1. A topical formulation for treatment of alopecia and hair care wherein the same
comprises extracts of
dried Leech
dried seeds of Celastrus paniculatus
dried parts like (leaf, bark, rind, root, branch, stem, fruits and flowers) of Nyctanthes arbortristis in Sesame oil and water
2. The novel topical formulation as claimed in claim 1, wherein the ingredients
required are :
• dried Leech 6 - 12 % optimally 9.5% (w/w).
• dried seeds of Celastrus paniculatus -6-12 % Optimally 9.5 % (w/w).
• dried parts like (leaf, bark, rind, root, branch, stem, fruits and flowers) of Nyctanthes arbortristis - 6-12 % optimally 9.5 %(w/w).
• Sesame oil - 30 - 60 % optimally 47.7% (w/w).
• Water -15-30 % optimally 23.8% (w/w)
3. A process for preparation of the novel topical formulation as claimed in claim 1
and claim 2 comprising the steps of:
• Taking appropriate amount of powdered leech and dipping it in desired quantity of Sesame oil over night.
• Adding appropriate amount of powdered parts of Celastrus paniculatus and Nyctanthes arbortristis to above prepared composition.
• Heating the composition for 3-4 hours
• Adding required quantity of water every 14 an hour
• Allowing the composition to cool for 4-5 hours
• Filtering the same using appropriate filtering matrix such as muslin cloth
4. The novel topical formulation as described substantially herein with reference to the detailed description and example.