A Two Arm, Randomized, Multicenter, Single blind, Prospective, Clinical study to evaluate efficacy & safety of PS/MAR/HO-1 oil and a marketed formulation in mild to moderate Hair loss in females

Female subjects between the age group of 18- 40 years (both inclusive) will be screened for eligibility criteria. On screening visit (Day -3), a written informed consent will be taken. Assessment of inclusion & exclusion criteria will be done. Assessment of hair loss will be done and those having mild to moderate hair loss (by comb test) will be included in the study. If Subjects are eligible, then they will be enrolled in the study. Subject’s clinical examination, both General & Hair Specific will be done and past history of any illness or medicines will be recorded. Hemoglobin and TSH will be done to evaluate if the subject has Anemia or Thyroid disorder. Prakriti evaluation will be done. Subjects will be advised not to take any medication for the treatment of Hair loss except the study medication during the study period.

  Subject will be asked to come on the 3rd day (Day 0) on which the subject will be asked to do hair fall test in the presence of the investigator and the hair will be counted and collected in labeled poly bag and documented in the CRF. Subjects will be asked to collect all hair that comes in the comb on this day also. Clinical examinations, both General & Hair Specific will be done. Subjects will be assigned to either Group A or Group B based on computer generated randomization list and the respective hair oil bottle will be dispensed. Labelled Plastic bags will be provided to the subjects for Hair sample collection by comb test. Subjects will be advised to apply 5 to 10 ml hair oil daily on the scalp followed by gentle massage for 10 minutes. Subjects will be asked to do hair wash after every two days interval. The schedule for hair wash, and comb test will be given to the subjects and they will be asked to follow the same. Subjects will be interrogated based on questionnaire to evaluate their quality of hair (both on graded scale and VAS).

  Subjects will be interrogated based on questionnaire to evaluate their quality of hair (both on graded scale and VAS) including effect on dandruff, greying and hair growth.  Subjects will be called to the investigators site on day 15, 30, 45 for follow up. At every follow up visit clinical examinations, both General & Hair Specific will be done. Subjects will be asked for any adverse event during this period. Assessment of Hair loss will be done by comb test in the presence of investigator. Plastic bags of Hair samples will be collected from subjects, done by comb test. Subjects will be interrogated based on questionnaire to evaluate their quality of hair (both on graded scale and VAS).

  On day 60 i.e. end of treatment visit, clinical examinations, both General & Hair Specific will be done. Subjects will be asked for any adverse event during this period. Assessment of Hair loss will be done by comb test in the presence of investigator. Plastic bags of Hair samples will be collected from subjects. Subjects will be interrogated based on questionnaire to evaluate their quality of hair (both on graded scale and VAS) including effect on dandruff, greying and hair growth. Subjects will be advised to stop trial medication & take advice of investigator for further treatment.