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CTRI Number  CTRI/2022/09/045770 [Registered on: 22/09/2022] Trial Registered Prospectively
Last Modified On: 30/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To Evaluate the Effects of Ashwagandha capsule on Skin and Hair Health in Healthy adults 
Scientific Title of Study   A Prospective, Randomized, Double-Blind, Placebo Controlled Clinical Study to Evaluate the Effects of KSM-66 Ashwagandha® capsule (300 mg) on Skin and Hair Health in Healthy Men and Women  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sharmila Patil 
Designation  Prof and Head Dermatology 
Affiliation  D Y Patil Medical College Hospital and Research Centre 
Address  D Y Patil Medical College Hospital and Research Centre D Y Patil University School of Medicine Sector 5 Nerul Navi Mumbai

Raigarh
MAHARASHTRA
400706
India 
Phone  08850635503  
Fax    
Email  sharmila.patil@dypatil.edu  
 
Details of Contact Person
Scientific Query  
Name  Deepakkumar Langade 
Designation  Prof and Head Pharmacologist 
Affiliation  D Y Patil Medical College Hospital and Research Centre 
Address  D Y Patil Medical College Hospital & Research Center D Y Patil University School of Medicine Sector 5 Nerul Navi Mumbai

Raigarh
MAHARASHTRA
400 706
India 
Phone  09930550009  
Fax    
Email  drdgl@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Deepakkumar Langade 
Designation  Prof and Head Pharmacologist 
Affiliation  D Y Patil Medical College Hospital and Research Centre 
Address  D Y Patil Medical College Hospital & Research Center D Y Patil University School of Medicine Sector 5 Nerul Navi Mumbai

Parbhani
MAHARASHTRA
400 706
India 
Phone  09930550009  
Fax    
Email  drdgl@hotmail.com  
 
Source of Monetary or Material Support  
Ixoreal Biomed Private Limited, 5-9-225, Sanali Estate, Abids, Hyderabad - 500001 Ph: (91) 40-23204385 / 86 / 87 India 
 
Primary Sponsor  
Name  Ixoreal Biomed Private Limited 
Address  5-9-225, Sanali Estate, Abids, Hyderabad - 500001 Ph: (91) 40-23204385 / 86 / 87 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sharmila Patil  D.Y. Patil Medical College  D Y Patil Medical College Hospital and Research Centre D Y Patil University School of Medicine Sector 5 Nerul Navi Mumbai
Raigarh
MAHARASHTRA 		 08850635503

sharmila.patil@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, D Y Patil Medical College, Nerul, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Male and female 18 to 60 years age 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  KSM-66 capsules containing Ashwagandha 300 mg standardized root extract  Standardized root extract 300 mg to be taken two times in a day orally with water/milk for period of 12 weeks 
Comparator Agent  Placebo Capsule (Identical to intervention Capsule)  Identical Capsule containing starch 300 mg to be taken two times in a day orally with water/milk for period of 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Healthy adult men and women participants ≥ 18 years and ≤60 years of age.
2. Willingness to follow the protocol requirements as evidenced by written informed consent.
3. Participants who were on consistent dietary, hair, and skin product
3 months prior to start of the study and are willing to follow the same during the study.
4. Participants who agree not to use any medication (prescription and over the counter), including vitamins and minerals, during or before
the course of this study.
5. Participants with mild to moderate hair loss classified as the Norwood-Hamilton type II, III, IV and V in males and Ludwig type I and II in females.
6. Willing to come for all follow-up visits.
7. Participants who agree not to cut hair for the entire duration of the study.
8. Participants willing to undergo Trichoscan evaluation and not to wash their hair 48 hours before the visit.
9. Participants willing to take proper contraceptives during the study and period.
10. Participants or LAR can and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
11. Participants who agree to take investigational product (i.e., Till Day 90 ± 4 ± 4).
 
 
ExclusionCriteria 
Details  1. Participants having any clinically significant medical history, medical finding including rosacea, eczema, psoriasis, and atopic dermatitis or an on-going medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with
the completion of study according to the protocol.
2. Participants on any medication or supplement for hair loss, including finasteride, any other 5 α-reductase inhibitor, minoxidil, steroids, or hormonal products, during the 3 months prior to study commencement.
3. Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to study medication).
4. Participants who have undergone or plan to undergo hair transplantation surgery during the study period.
5. Participants with facial skin cancer.
6. Participants with sunburn, moderate to pronounced suntan, uneven skin tones, tattoos, scars or other disfiguration, dilated vessels or
other conditions on the test area that might influence the test results.
7. Participants with severe seborrheic dermatitis, alopecic disease, except for androgenic alopecia, and scalp disorders, such as scalp psoriasis and infection
8. Participants who have participated in a clinical study during the preceding 180 days.
9. Participants having eating disorders (i.e., bulimia, psychogenic eating disorders, etc.).
10. Pregnant and lactating females
11. Participants with alcohol addiction or persistent abuse of drugs of dependence. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Trans Epidermal Water Loss (TEWL) Assessment  Baseline, 12 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Trichoscan analysis  Baseline, 12 Weeks 
DLQI Questionnaire score
assessment  		 Baseline, 12 Weeks 
Hair Skindex-29 Questionnaire
score assessment 		 Baseline, 12 Weeks 
Subjects Self-Assessment of
improvement 		 Baseline, 12 Weeks 
Clinical Global Impression – Improvement scale (CGI-I)  Baseline, 12 Weeks 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/09/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study.
Subjects will be informed about the purpose of the study and signed informed consent will be taken.
Efficacy assessments mentioned above will be done appropriately during the study.
All Subjects will be followed-up during the study period (Screening /Baseline, Day-45 (telephonic), and Day 90 ± 4) till complete the course of treatment.
 
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