Abstract
BACKGROUND: Alopecia is a dermatological condition affecting genders, negatively impacting their personality and quality of life (QoL). The current approved entities are limited, inconsistently effective, and associated with negative side effects. To alleviate this issue, ayurvedic herbs such as Ashwagandha have being explored. As a result, this study was designed to evaluate the efficacy and safety of Ashwagandha (root extract) topical formulation (serum) on hair health in healthy adults. METHODS: In this prospective, double-blind, randomized, placebo controlled, two arm, parallel, comparative study, the effects of topical Ashwagandha on the hair health was evaluated. Healthy adults between 18 and 45 years with mild to moderate hair loss were randomized to either Ashwagandha (topical) or Placebo (topical) treatment. The participants were assessed at Day-1 and Day-75 for change in efficacy parameters, which included 60 Seconds Hair Comb, Trichoscan analysis, Hair Pull test, Investigator's Global Assessment (IGA) and QoL using Hair-specific Skindex-29. RESULTS: In the per protocol analysis of 61 participants, Ashwagandha group demonstrated significant reduction in hair shedding in the 60 Seconds Hair Comb test compared to Placebo at day 75. Similarly, Ashwagandha substantially enhanced hair density, growth, and thickness compared to the Placebo group (density = 7.3 vs. 2.8, P < 0.001; growth = 21.7 vs. 4.2, P < 0.001; thickness = 1.8 vs. 0.9, P < 0.001). In addition, Ashwagandha significantly improved QOL compared to placebo (Score = -17.3 vs. -6.1, P = 0.011). CONCLUSION: The study found that topical Ashwagandha (serum) improved hair growth and hair health indicators. Thus, it can be an effective and safer alternative for alopecia. STUDY REGISTRATION: CTRI, Number CTRI/2022/11/047539, Registered on: 23/11/2022.