| CTRI Number |
CTRI/2022/05/042393 [Registered on: 06/05/2022] Trial Registered Prospectively |
| Last Modified On: |
18/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study on AP/VJT/SBO Ayurvedic Hair Oil in females |
|
Scientific Title of Study
|
A Randomized, Multi-center, Prospective, Comparative Clinical Study to evaluate efficacy and safety of AP/VJT/SBO Ayurvedic Hair Oil in mild to moderate Hair loss in females |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AP/VJT/SBO/01/2022, Version no. 1.0 Dated 26th Feb 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaam Agarwal |
| Designation |
Dermatologist |
| Affiliation |
The Skin Hair Laser Clinic |
| Address |
The Skin Hair Laser Clinic
Ground Floor, South Main Road, Sukhwari Classic, Koregaon Park, Pune 411001.
Pune
MAHARASHTRA
411001
India |
| Phone |
9422026123 |
| Fax |
|
| Email |
shaamagarwal11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai 400064
Mumbai (Suburban)
MAHARASHTRA
400064
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 Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai 400064
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| AYURVED PRATISTHAN
Plot no 7/87/8, Kshirsagar Colony,
Hirwadi Road, Panchavati,
Nasik- 422003. |
|
|
Primary Sponsor
|
| Name |
AYURVED PRATISTHAN |
| Address |
Plot no 7/87/8, Kshirsagar Colony, Hirwadi Road, Panchavati, Nasik- 422003.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aboli Patil |
Dr. D.Y. Patil College of Ayurved & Research Centre |
OPD No. 01, Department of Kaumarbhritya
Floor –Ground floor, Dr. D.Y. Patil College of Ayurved & Research Centre, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Pune- 411018
Pune
MAHARASHTRA |
9422783313
drabolipatil@gmail.com |
| Dr Jayant Janardan Phadke |
Pune District Education Association Pune, College of Ayurveda & Research Center |
Agad Tantra Dept.
OPD No. 117 B, Ground floor,
Pune District Education Association Pune, College of Ayurveda & Research Center, Sector No. 25, Pradhikaran, Nigdi, Pune-411044
Pune
MAHARASHTRA |
9822615265
jayantphadke10@gmail.com |
| Dr Shaam Agarwal |
The Skin Hair Laser Clinic |
Ground Floor, South Main Road, Sukhwari Classic, Koregaon Park, Pune 411001.
Contact No-
Email:
Pune
MAHARASHTRA |
9422026123
shaamagarwal11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee, Mhaske Hospital and Research Centre Gadital, Hadapsar, Pune |
Approved |
| Institutional Ethics Committee -II, Pune District Education Association’s, College of Ayurved & Research Centre, Nigdi, Pune |
Submittted/Under Review |
| Institutional Ethics Committee, Dr. D.Y. Patil College of Ayurved & Research Centre, Pimpri-Chinchwad, Pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L658||Other specified nonscarring hair loss. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Control Group | Subjects in this group will be infrequent hair oil users. Those who apply hair oil once or twice weekly will be considered as infrequent hair oil users | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: AP/VJT/SBO Ayurvedic Hair, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Samudga, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: Subjects will be asked to apply approximately 10 ml of hair oil for minimum 3 times a week. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Subjects suffering from mild to moderate hair loss (40-140 Hair by Comb test and Finger 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 disorder/s 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/planning a pregnancy or lactating.
11. Menopausal Women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Comparative assessment of hair fall by running finger test
2. Comparative assessment of hair breakage by comb test
|
Screening visit, Baseline visit, Day 15, Day 30, Day 45 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparative assessment of hair fall by Hair Pull test
2. Comparative assessment of hair growth
3. Comparative assessment of effect on dandruff
4. Comparative assessment of effect on quality of hair
5. Global assessment of overall change by physician and subject
6. Assessment of safety and adverse events
|
Screening visit, Baseline visit, Day 15, Day 30, Day 45 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/05/2022 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a randomized, multi-center,
prospective, comparative, clinical study to evaluate efficacy and safety of AP/VJT/SBO Ayurvedic Hair Oil in
mild to moderate hair loss in females. The study will be conducted in three centers
in India. Subjects will be asked to apply approximately 10 ml of hair oil for minimum
3 times a week. The primary objective
of the study will be to assess hair fall by running finger test and hair
breakage by comb test. The secondary
objectives of the study will be to assess hair fall by Hair Pull test, hair
growth, effect on dandruff, effect on quality of hair, global assessment of
overall change by physician and subject and assessment of safety and adverse
events on screening visit, baseline visit, day 15, day 30, day 45 and day 60 |