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
|
|
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
|
|
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. |