A clinical trial to study the efficacy of herbal hair oil.

Phase 2/3

Active, not recruiting

Brief Summary: **STUDY OBJECTIVES:** To investigate the efficacy of Herbal hair oil in healthy adult volunteers by assessing the gross hair growth and counting the number of active hair follicles on the scalp.**STUDY DESIGN:** A randomized study over a 3-months period. Volunteers will be screened and eligible subjects during Visit 1 will be randomized to either Herbal hair oil b.i.d or Coconut oil b.i.d of similar appearance. Visits 2, 3, 4, 5 and 6 (final) will be scheduled at monthly intervals. Safety tests will be repeated at each of the study visits (except visit 2). Patients will enter adverse events and daily use of study medication in a subject diary. This will serve as a measure of compliance. **Efficacy Assessment:**

Overall efficacy assessment of hair oil is based on four point scale (i.e. bad, average, good & excellent) for hair & scalp related ailment. Patient will be undergoing monthly follow up for 3 months on the basis of following criteria:

a. Effectiveness â€“ Hair growth/Hair fall control

b. Promotion of hair growth will be measured using trichoscopy c. Hair strength: tensile strength will be measured using Uni axial mechanical testing machine collecting hair of 5 cm long **Analysis of scalp photograph:** Trichoscopy data of all subjects from each group will be compared to check the efficacy of treatment along with tensile strength.

Recruitment & Eligibility

Inclusion Criteria

be informed of the nature of the study and will be asked to give a written consent 2.To have body weights within 25% of the appropriate weight range, 3.
Must be free from significant diseases or clinically significant abnormal laboratory values during screening, 4.
Normal ECG 5.
Should not be taking any other treatment for hair growth 6.
Must be able to communicate effectively with study personnel 7.
hair fall due to chemotherapy.

Exclusion Criteria

Any disease or condition which might compromise the haematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
History of allergic conditions â€“ asthma, urticaria, eczema.
History of autoimmune disorders â€“ lupus erythematosis (SLE) 4.
History or presence of dyspepsia, gastric ulcer or duodenal ulcer.
History of psychiatric disorders.
Recent history of alcoholism (<2 years) or consumption of alcohol within 48 hours of receiving study medication.
Smokers, who smoke more than 10 cigarettes per day and cannot refrain from smoking during the study period.
Androgenic alopecia 9.
Presence of clinically significant abnormal laboratory results during screening.
Use of any recreational drugs or a history of drug addiction.
History of Anaemia 12.
History of Dandruff, Head lice and pediculosis 13.
History of irregular menstruation and PCOD 14.
History of Hypo and Hyper Thyroidism.
History of Diabetes.

Primary Outcome Measures

Name	Time	Method
Increase in hair length, reduction of hair loss and promotion of new hair growth	Increase in hair length, reduction of hair loss and promotion of new hair growth

Secondary Outcome Measures

Name	Time	Method
Marketing of Evidence based Herbal hair oil for personal care	one year

Locations (1): Thanjavur Medical College Hospital
🇮🇳
Thanjavur, TAMIL NADU, India
Thanjavur Medical College Hospital
🇮🇳Thanjavur, TAMIL NADU, India
Dr M Vinnarasan
Principal investigator
09443173632
deva.ayur@gmail.com