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CTRI Number  CTRI/2023/06/053922 [Registered on: 15/06/2023] Trial Registered Prospectively
Last Modified On: 14/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Hair Benefit Study For The Ayurvedic Proprietary Medicine  
Scientific Title of Study   A clinical study to evaluate the efficacy of the test products in improving hair growth & hair fall reduction. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HAIR/ULHF/2023-05 Version 1.0 dated 19 May 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukesh Ramnane  
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934   
Fax    
Email  mukesh.ramnane@msclinical.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arya  
Designation  Co-Investigator, BAMS  
Affiliation  MS Clinical Research Pvt Ltd 
Address  Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560058
India 
Phone  08041125934   
Fax    
Email  arya.p@msclinical.com  
 
Details of Contact Person
Public Query  
Name  Sudhanthiran S  
Designation  Study Manager  
Affiliation  MS Clinical Research Pvt Ltd  
Address  First Floor, Room no. 1, Councelling Area, 327/15, 1st main road, cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934   
Fax    
Email  sudhan@msclinical.com  
 
Source of Monetary or Material Support  
Hindustan Unilever Ltd Research Center Stores, B.D. Sawant Marg, Chakala, Andheri (East) Mumbai, 27 – 400099, India  
 
Primary Sponsor  
Name  Hindustan Unilever Ltd 
Address  Research Center Stores, B.D. Sawant Marg, Chakala, Andheri (East) Mumbai, 27 – 400099, India  
Type of Sponsor  Other [FMCG(Fast moving Consumer Goods)]] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mukesh Ramnane  MS Clinical Research Pvt. Ltd  Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor
Bangalore
KARNATAKA 		 08041125934
08040917253
mukesh.ramnane@msclinical.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ICD-10 code: L65. 9 Nonscarring hair loss, unspecified (Khalitya). 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: Thrice a week for 12 weeks, Ritucarya: , Acara Rasayana:, Other:AP27, Pathya/Apathya:no, Pathya:, Apathya:
2Comparator ArmLifestyle--Dinacarya: Thrice a week for 12 weeks, Ritucarya: , Acara Rasayana:, Other:PC 45, Pathya/Apathya:no, Pathya:, Apathya:
3Comparator ArmLifestyle--Dinacarya: Thrice a week for 12 weeks, Ritucarya: , Acara Rasayana:, Other:GF 66, Pathya/Apathya:no, Pathya:, Apathya:
4Comparator ArmLifestyle--Dinacarya: Thrice a week for 12 weeks, Ritucarya: , Acara Rasayana:, Other:WS81, Pathya/Apathya:no, Pathya:, Apathya:
5Comparator ArmLifestyle--Dinacarya: Thrice a week for 12 weeks, Ritucarya: , Acara Rasayana:, Other:SH 01, Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Male and female volunteers in general good health with mild to moderate hair fall
2. Volunteers in the age group 18-50 years (both the ages inclusive).
3. Volunteers willing to give a written informed consent and agree to come for a regular follow up visit.
4. Volunteers willing to abide by and comply with the study protocol.
5. Volunteers who have not participated in a similar investigation in the past three months.
6. Volunteers with no known allergy as established by medical history.
7. Volunteers who do not smoke or drink alcohol.
8. Volunteers who are not crash dieting.
9. Volunteers who agree to refrain from using hair dye / hair colour during the study period.
10. Volunteers willing to refrain from any type of hair treatment like perming, straightening etc. during the study duration.
11. Volunteers who are willing to refrain from any other oil treatment/hair spa and oral medications for hair growth during the study.
 
 
ExclusionCriteria 
Details  1. Volunteers who have undergone hair growth treatment within 3 months before screening into the study.
2. Volunteers having any active scalp disease which may interfere in the study dermatologist’s judgement.
3. Volunteers who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
4. Volunteers who have history of alcoholism and/ or psychiatric disorder including trichotillomania.
5. Volunteers who have had hair transplants.
6. Volunteers who take pharmaceutical product which cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia.
7. A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
8. Volunteers consuming alcohol and smoking
9. Volunteers on oral medications which will compromise the study.
10. Volunteers who are pregnant or lactating or nursing as established with medical history.
11. Volunteers under any medical treatment for hair problems
12. Undergoing any chemical hair salon treatment-straightening / perming / colour
13. Menopausal female volunteers as determined by medical history.
14. Pregnant and lactating female volunteers
15. Chronic illness which may influence the cutaneous state. Volunteers participating in other similar cosmetic or therapeutic trial within last three months.
16. Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Significant improvement in hair growth, reduction in hair fall
2. Significant reduction in Kesh chyuti or kalitya (hair fall)  		 4, 8, 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Significant improvement in hair fibre thickness  4, 8, 12 weeks 
 
Target Sample Size   Total Sample Size="225"
Sample Size from India="225" 
Final Enrollment numbers achieved (Total)= "216"
Final Enrollment numbers achieved (India)="216" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   17/06/2023 
Date of Study Completion (India) 28/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Study will be conducted to assess the efficacy of test product in imparting Hair growth  benefits. After obtaining Informed consent form and qualifying the inclusion and exclusion criteria, subjects will be enrolled into the study. The subjects will undergo 2 weeks of wash out. Post wash out period, test products will be dispensed to subjects. Post base line assessment subjects will be instructed to use the product thrice a week for 3 months.  All evaluation assessments will be done at different times – 4 weeks, 8 weeks and 12 weeks. 
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