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CTRI Number  CTRI/2015/12/006462 [Registered on: 23/12/2015] Trial Registered Retrospectively
Last Modified On: 09/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of efficacy of PS/MAR/HO-1 oil and a marketed formulation in mild to moderate Hair loss in females 
Scientific Title of Study   A Two Arm, Randomized, Multicenter, Single blind, Prospective, Clinical study to evaluate efficacy & safety of PS/MAR/HO-1 oil and a marketed formulation in mild to moderate Hair loss in females  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
PS/M/01/2015, Version 1.0,Dated 20 Jan 2015 20  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meenakshi Rewedkar 
Designation  Assistant Professor 
Affiliation  R A Podar Medical College (Ayu) and M.A. Podar Hospital 
Address  OPD No. 12, Ground Floor, Department of Kayachikitsa, R A Podar Medical College (Ayu) and M.A. Podar Hospital, Dr Annie Besant Road, Worli, Mumbai

Mumbai
MAHARASHTRA
400018
India 
Phone  09757476325  
Fax    
Email  drmrevadkar@yahoo.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 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 205, B Wing, Blue Diamond Society, Nayagoan, Dahisar (West),Mumbai


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 = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mrs Suchita Pande  Ayurved Seva Sangh’s Ayurved Mahavidyalaya and Arogya Shala Rugnalay   Sanshodhan Vibhag OPD No.9,Sanshodhan Department Ayurved Seva Sangh’s Ayurved Mahavidyalaya and Arogya Shala Rugnalay Ganeshwadi, Panchvati, Nashik.Pin 422003
Nashik
MAHARASHTRA 
9420830818

shishir.nsk@gmail.com 
Dr Birajdar D G  Dhanwantri Hospital  Dhanwantri Hospital, First Floor, Pune-Nagar road, Wagholi, Tal-Haveli, Dist-Pune 412207
Pune
MAHARASHTRA 
9881707412

drbirajdarskin@gmail.com 
Dr Vaishali Deshpande   MAMS Sumatibhai Shah   OPD No. 2, Dept of Kayachikitsa, MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Saneguruji Aarogya Kendra, Malwadi, Hadapsar, Pune-411028 M: E mail :
Pune
MAHARASHTRA 
9096082950

drvaishalid@gmail.com 
Dr Meenakshi Rewedkar  R A Podar Medical College (Ayu) and M.A. Podar Hospital  OPD No. 12, Ground Floor, Department of Kayachikitsa, R A Podar Medical College (Ayu) and M.A. Podar Hospital, Dr Annie Besant Road, Worli, Mumbai 400018
Mumbai
MAHARASHTRA 
09757476325

drmrevadkar@yahoo.com 
Dr Sachin Agiwal  Shree Gurudeo Ayurved College & Hospital  OPD No.28, Department of Swasthrakshan, Shree Gurudeo Ayurved College & Hospital, Gurukunj, Ashram. Tal. Tiosa, Dist. Amravati, Pin 444902
Amravati
MAHARASHTRA 
9421829197

sachin.agiwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Independent Ethics Committee, Dhanashree Hospital  Submittted/Under Review 
Institutional Ethics Committee, Ayurved Seva Sangh’s Ayurved Mahavidyalaya and Arogya Shala Rugnalay   Approved 
Institutional Ethics Committee, Shree Gurudeo Ayurved College & Hospital, Gurukunj, Ashram  Approved 
Institutional Ethics Committee, R A Podar Medical College (Ayu) and M.A. Podar Hospita  Submittted/Under Review 
Institutional Ethics Committee,MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Saneguruji Aarogya Kendra  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Hair Fall,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PS/MAR/HO-1 Oil   Amla (Emblica officinalis), Nagarmotha (Cyperus rotundus, Methi (Fenugreek) (Trigonella foenum-graecum), Mehandi (Henna) (Lawsonia inermis), Aloe Vera (Aloe barbadensis), Processed in Sesame oil Dosage and Duration of application: Subjects will be asked to apply approximately 5-10 ml of hair oil every day for 60 days.  
Comparator Agent  PS/SBS/HO-02  Subjects will be asked to apply marketed hair oil (PS/SBS/HO-02) approximately 5-10 ml every day for 60 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Female subjects between the age group of 18- 40 years both inclusive
2. Subjects suffering from mild to moderate hair loss (by comb test).
3. Subjects who are infrequent hair oil users
4. Subjects who are willing to give informed consent and ready to comply with the protocol
5. 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.
2. Subject with severe dermatological disorders of the scalp
3. Subjects with recent disease history like, malaria, typhoid, jaundice & scalp diseases
4. Subjects who have regularly used anti-hair fall treatment with hair oils over last 6 months.
5. Subjects who have previously undergone hair transplantation
6. Subjects on immunosuppressive drugs
7. Subjects on systemic steroids for more than 14 days within last 2 months
8. Pregnant/planning a pregnancy or lactating, menopausal Women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of efficacy of PS/MAR/HO-01 oil in mild to moderate hair loss in females   Day 0, Day 15, Day 30, Day 45, Day 60  
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessment of efficacy of PS/MAR/HO-01 oil in comparison with a marketed preparation
2. Assessment of effect of PS/MAR/HO-01 oil in comparison with and marketed preparation oil on quality of hair based on subject questionnaire including dandruff, greying and hair growth.
3. Global assessment of overall change in hair loss by the physician and subject.
4. Assessment of safety by observing any allergic reactions & adverse events  
Day 0, Day 15, Day 30, Day 45, Day 60 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   16/05/2015 
Date of Study Completion (India) Date Missing 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Female subjects between the age group of 18- 40 years (both inclusive) will be screened for eligibility criteria. On screening visit (Day -3), a written informed consent will be taken. Assessment of inclusion & exclusion criteria will be done. Assessment of hair loss will be done and those having mild to moderate hair loss (by comb test) will be included in the study. If Subjects are eligible, then they will be enrolled in the study. Subject’s clinical examination, both General & Hair Specific will be done and past history of any illness or medicines will be recorded. Hemoglobin and TSH will be done to evaluate if the subject has Anemia or Thyroid disorder. Prakriti evaluation will be done. Subjects will be advised not to take any medication for the treatment of Hair loss except the study medication during the study period.

 

Subject will be asked to come on the 3rd day (Day 0) on which the subject will be asked to do hair fall test in the presence of the investigator and the hair will be counted and collected in labeled poly bag and documented in the CRF. Subjects will be asked to collect all hair that comes in the comb on this day also. Clinical examinations, both General & Hair Specific will be done. Subjects will be assigned to either Group A or Group B based on computer generated randomization list and the respective hair oil bottle will be dispensed. Labelled Plastic bags will be provided to the subjects for Hair sample collection by comb test. Subjects will be advised to apply 5 to 10 ml hair oil daily on the scalp followed by gentle massage for 10 minutes. Subjects will be asked to do hair wash after every two days interval. The schedule for hair wash, and comb test will be given to the subjects and they will be asked to follow the same. Subjects will be interrogated based on questionnaire to evaluate their quality of hair (both on graded scale and VAS).

 

Subjects will be interrogated based on questionnaire to evaluate their quality of hair (both on graded scale and VAS) including effect on dandruff, greying and hair growth.  Subjects will be called to the investigators site on day 15, 30, 45 for follow up. At every follow up visit clinical examinations, both General & Hair Specific will be done. Subjects will be asked for any adverse event during this period. Assessment of Hair loss will be done by comb test in the presence of investigator. Plastic bags of Hair samples will be collected from subjects, done by comb test. Subjects will be interrogated based on questionnaire to evaluate their quality of hair (both on graded scale and VAS).

 

On day 60 i.e. end of treatment visit, clinical examinations, both General & Hair Specific will be done. Subjects will be asked for any adverse event during this period. Assessment of Hair loss will be done by comb test in the presence of investigator. Plastic bags of Hair samples will be collected from subjects. Subjects will be interrogated based on questionnaire to evaluate their quality of hair (both on graded scale and VAS) including effect on dandruff, greying and hair growth. Subjects will be advised to stop trial medication & take advice of investigator for further treatment. 
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