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CTRI Number  CTRI/2017/08/009528 [Registered on: 29/08/2017] Trial Registered Retrospectively
Last Modified On: 02/09/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical study of MAR/HO-2 oil in mild to moderate Hair loss in females 
Scientific Title of Study   A single Arm, Multicenter, Prospective, Clinical study to evaluate efficacy and safety of MAR/HO-2 oil in mild to moderate Hair loss in females 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MAR/02/2015, Version 1.0,Dated 02 Sep 2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajashree Kulkarni  
Designation  Ayurvedic Consultant  
Affiliation  Ayushree Ayurvedic Hospital and Research center  
Address  OPD No. 1, Ground Floor, OPD Department, Ayushree Ayurvedic Hospital and Research center Parabnagar, Indira Nagar Nashik

Nashik
MAHARASHTRA
422006
India 
Phone  9822537666  
Fax    
Email  drrajashree@ayushree.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Tamoli  
Designation  Director 
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research Ground Floor Office No. 1, 205 B Wing Blue Diamond Society Nayagoan Dahisar West Mumbai

Mumbai (Suburban)
MAHARASHTRA
400068
India 
Phone  9322522252  
Fax    
Email  targetinstitute@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay Tamoli  
Designation  Director 
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research Ground Floor Office No. 1, 205 B Wing Blue Diamond Society Nayagoan Dahisar West Mumbai

Mumbai (Suburban)
MAHARASHTRA
400068
India 
Phone  9322522252  
Fax    
Email  targetinstitute@yahoo.com  
 
Source of Monetary or Material Support  
Marico Ltd. Plot No: 23/C, Mahal Industrial Estate, Near Ahura Centre, Paper Box Gali, Mahakali Caves Road, Andheri (E), Mumbai-400093 
 
Primary Sponsor  
Name  Marico Ltd 
Address  Plot No: 23/C, Mahal Industrial Estate, Near Ahura Centre, Paper Box Gali, Mahakali Caves Road, Andheri (E), Mumbai-400093 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajashree Kulkarni  Ayushree Ayurvedic Hospital and Research Center  OPD No. 1, Ground Floor, OPD Department, Ayushree Ayurvedic Hospital and Research center Parabnagar, Indira Nagar Nashik
Nashik
MAHARASHTRA 		 9822537666

drrajashree@ayushree.com 
Dr Sachin Agiwal  Shri Gurudeo Ayurved College and Hospital   OPD No 28, Ground Floor, Department of Swasthrakshan Akhil Bharatiya Shri Gurudeo Sevamandal Shri Gurudeo Ayurved College and Hospital Gurukunj Ashram Tal Tiosa Dist Amravati
Amravati
MAHARASHTRA 		 9421829197

sachin.agiwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ayushree Ayurvedic Hospital Ethics Committee Nashik  Approved 
Institutional Ethics Committee, Akhil Bharatiya Shri Gurudeo Sevamandal, Shri Gurudeo Ayurved College, Gurukunj Amravati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Hair loss in females,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MAR/HO-02 Oil   MAR/HO-02 Oil Contains Amla (Emblica officinalis), Mehandi (Lawsania ineris), Methi (Trigonella foenum graecum), Kumari (Aloe vera), Musta (Cyperus rotundus) processed in Coconut oil. Dosage and Treatment Duration: Subjects will be asked to apply approximately 5-10 ml of hair oil every day for 60 days.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Subjects suffering from mild to moderate hair loss (by comb test).
2. Subjects who are infrequent hair oil users
3. Subjects who are willing to give informed consent and ready to comply with the protocol
4. Subjects who are ready to provide regular follow ups till the completion of the study
 
 
ExclusionCriteria 
Details  1. Subjects with severe Hair fall due to any clinically significant disorders like anemia, thyroid disorders etc.
2. Subject with severe dermatological disorders of the scalp that might interfere with the study evaluation
3. Subjects with recent disease history like, malaria, typhoid, jaundice and scalp diseases and subjects who in the opinion of the investigator are not eligible for enrollment in the clinical study
4. Subjects who have regularly used anti-hair fall treatment with hair oils over the last 6 months.
5. Subjects who have previously undergone hair transplantation procedures
6. Subjects on systemic steroids for more than 14 days within 2 months prior to enrollment.
7. Subjects on immunosuppressive drugs
8. Known cases of Hypersensitivity to hair oil contents
9. Subjects who have participated in any other clinical study since last 3 months
10. Subjects who are reported pregnant or planning a pregnancy or lactating.
11. Menopausal Women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of efficacy of MAR/HO-02 oil in mild to moderate hair loss in females (by running finger test and comb test)

 		 Day -5, Day 0, Day 15, Day 30, Day 45 and Day 60
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Assessment of effect of MAR/HO-02 on quality of hair based on subject questionnaire including effect on dandruff, greying and hair growth.
2.Global assessment of overall change in hair loss by the physician
3.Global assessment of overall change in hair loss by the subject
4.Assessment of safety by observing episodes, severity and duration of any allergic reactions and adverse events 		 Day -5, Day 0, Day 15, Day 30, Day 45 and Day 60 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   19/10/2015 
Date of Study Completion (India) 24/03/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Done 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a single Arm, Multicenter, Prospective, Clinical study to evaluate efficacy and safety of MAR/HO-2 oil in mild to moderate Hair loss in females. The study will be conducted in 50 female subjects. The study will be conducted at 2 centers in India. Subjects will be asked to apply approximately 5-10 ml of MAR/HO-2 hair oil every day for 60 days. The primary outcome will be to assess efficacy of MAR/HO-02 oil in mild to moderate hair loss in females by running finger test and comb test. (Day -5, Day 0, Day 15, Day 30, Day 45 and Day 60). The secondary outcomes will be to assess effect of MAR/HO-02 on quality of hair based on subject questionnaire including effect on dandruff, greying and hair growth, global assessment of overall change in hair loss by physician and by subject and safety by observing episodes, severity and duration of any allergic reactions and adverse events (Day -5, Day 0, Day 15, Day 30, Day 45 and Day 60)

 
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