| CTRI Number |
CTRI/2022/06/043013 [Registered on: 03/06/2022] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| 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 NANSHO Hair Oil in Hair loss in females. |
|
Scientific Title of Study
|
A Randomized, Prospective, Comparative Clinical Study to evaluate efficacy and safety of NANSHO Hair Oil in mild to moderate Hair loss in females. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA/NANSHO/01/2022, Version no. 1.0 Dated 8th Apr 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pawar Anand Mukundrao |
| Designation |
Principal |
| Affiliation |
Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur |
| Address |
OPD No. 10, Ground floor, Department of Panchakarma, Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur, Behind Bus Stand, Gandhi Maidan, Latur – 413512.
Latur
MAHARASHTRA
413512
India |
| Phone |
9405647469 |
| Fax |
|
| Email |
vd_ananda@rediffmail.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
|
| Namaskar Ayurved Private Limited,
Unit - 4, Ground Floor,Peninsula Chambers
Peninsula Corp Park G K Marg Lower Parel
Mumbai-400013 |
|
|
Primary Sponsor
|
| Name |
Namaskar Ayurved Private Limited |
| Address |
Unit - 4, Ground Floor,Peninsula Chambers
Peninsula Corp Park G K Marg Lower Parel
Mumbai-400013
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pawar Anand Mukundrao |
Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital |
OPD No. 10, Ground floor, Department of Panchakarma, Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur, Behind Bus Stand, Gandhi Maidan, Latur – 413512.
Latur
MAHARASHTRA |
9405647469
vd_ananda@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L659||Nonscarring hair loss, unspecified. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: NANSHO HAIR OIL, 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 for 60 days. | | 2 | Comparator Arm (Non Ayurveda) | | - | Control Group (Infrequent hair oil Users) | 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. |
|
|
|
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
|
Not Applicable |
|
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)= "71"
Final Enrollment numbers achieved (India)="71" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/06/2022 |
| Date of Study Completion (India) |
06/09/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is a randomized, prospective, comparative, clinical study to evaluate efficacy and safety of NANSHO HAIR OIL in mild to moderate hair loss in females. Subjects will be asked to apply approximately 10 ml of hair oil for minimum 3 times a week. The primary objectives 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.
Results and Conclusion:
NANSHO Hair oil was significantly effective in
reducing hair fall in female subjects suffering from mild to moderate hair
loss. NANSHO Hair oil was significantly effective in improving hair growth. It
also effectively improved hair density, appearance and smoothness of the hair,
thickness of hair and overall quality of hair and reducing dandruff of
hair/scalp. NANSHO Hair oil was found to be dermatologically safe without
producing any adverse effects. |