A prospective, randomized, double blind, placebo controlled, two arm, parallel assignment study to evaluate clinical efficacy and safety of Hair growth Lotion + Tablet in the management of Androgenic alopecia (AGA).

Study Design: A prospective, randomized, double blind, Placebo controlled, two arm, parallel assignment study. Sample size: 60 subjects (30 in each arm) Genders Eligible for Study: Male Study duration: 4 months (As per investigator, if desirable findings are not observed after 4 months, study can be extended to 6 months) Treatment: Subjects will be assigned to the study medications as per the randomization schedule. Outcome Measures: Primary Outcome Measures (at baseline and after 4 months) i.Hair count by PTG (Phototrichograms) Secondary Outcome Measures xi.Self assessment by Patients (questionnaire) (after 2 and 4 months) xii.Physical examination of scalp (at baseline, after 1, 2, 3 and 4 months) xiii.Hair density rating scale (after 2 and 4 months) xiv.Global assessment by investigator (After treatment completion) xv.Compliance and adverse effects Subject?s Eligibility Assessments: Inclusion criteria: ?Men aged 18 to 49 years with mild to moderate signs of AGA, which is classified in Modified Norwood-Hamilton Scale as stage 3V, 4 and 5. ?Not be on a course of treatment, which affects the outcome of the study. ?Individuals who are willing to give informed consent and willing to follow up. ?No topical treatment for AGA for at least 6 weeks and no systemic treatment for at least 3 months prior to study initiation. ?Willing to refrain from other AGA treatments during the course of the study. ?Not have had hair chemically treated (including colored hair, permed hair, etc) within the month prior to the study. Exclusion criteria: ?Coexistent androgenetic alopecia other than 3V, 4 and 5 stages of Norwood-Hamilton scale ?Unwilling to maintain a consistent hair style and to avoid shaving of scalp hair throughout the course of the study. ?Unable to comply with the protocol. ?Patients who are on chronic oral steroids are not eligible for the study ?Allergies to Investigational product. ?Presence of irritated or visibly inflamed scalp. ?Use of ultraviolet radiation, including tanning beds and PUVA therapy for treatment of acne, psoriasis, or any other skin condition within 2 months prior to study initiation. ?Evidence of immunocompromise. ?Advanced or poorly controlled diabetes. ?Unstable cardiovascular disease. ?Clinically significant medical or psychiatric disease as determined by the investigator. ?Local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) within 3 months prior to the first dose of investigational drug. ?Those who have donated blood within a month of date of screening evaluation. ?Drug or alcohol abuse. Withdrawal criteria: ?Subject will be deemed as withdrawn from the study on request of participating individual. ?Repeated protocol criteria violation/deviation ?Serious adverse events/reaction where continuation of the study possess serious risk to the participants. Protocol deviation: Following criteria will be applicable to determine protocol deviation: ?Individual does not come within 7 days of his scheduled visit. ?Individual skips the medication twice daily. ?Individual takes other medication without consulting investigator. ?Individual does not bring study medication bottle at the time of visit. . Dropout: ?Individual is without study medication for more than 4 days consecutively in two week period. ?Individual does not report for the follow up within 8 days of his scheduled visit day, then he will be considered as a dropout