| CTRI Number |
CTRI/2023/06/054189 [Registered on: 20/06/2023] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the safety and efficacy of Nimson Amla Oil with Vitamin C in benefitting the hair growth ,reducing hair fall, greying of hair and dandruff |
|
Scientific Title of Study
|
A PROSPECTIVE, SINGLE ARM, OPEN LABEL, SINGLE CENTRE CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF NIMSON AMLA OIL WITH VITAMIN C IN BENEFITTING THE HAIR GROWTH, REDUCING HAIRFALL, GREYING OF HAIR AND DANDRUFF |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CTSRS/2304 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday Kumar S |
| Designation |
Principal Investigator |
| Affiliation |
Dr. Uday’s Advance Skin and Hair clinic |
| Address |
Dr. Uday’s Advance Skin and Hair clinic #2637/6, First Floor, Begur Rd Near Canara Bank, Begur.
Bangalore
KARNATAKA
560068
India |
| Phone |
6364147989 |
| Fax |
|
| Email |
info@samahitha.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr.Vijay Kimtata |
| Designation |
Research Technical |
| Affiliation |
Aryanveda Cosmoceuticals |
| Address |
Aryanveda Cosmoceuticals
128, Nalagarh Bhartgarh road, VPO Rajpura, Near GPI textile Pvt Ltd, Tehsil Nalagarh, Dist.Solan, Himachal Pradesh
Solan
HIMACHAL PRADESH
174101
India |
| Phone |
9816333352 |
| Fax |
|
| Email |
vijaykimtata.vk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sunita C |
| Designation |
Team Lead |
| Affiliation |
Samahitha Research Solutions |
| Address |
Samahitha Research Solutions
Bangalore
KARNATAKA
560069
India |
| Phone |
6364147980 |
| Fax |
|
| Email |
sunita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Aryanveda Cosmeceuticals
128, Nalagarh Bhartgarh road, VPO Rajpura, Near GPI textile Pvt Ltd, Tehsil Nalagarh, Dist. Solan, Himachal Pradesh-17410
|
|
|
Primary Sponsor
|
| Name |
Aryanveda Cosmeceuticals |
| Address |
128, Nalagarh Bhartgarh road, VPO Rajpura, Near GPI textile Pvt Ltd, Tehsil Nalagarh, Dist. Solan, Himachal Pradesh-17410 |
| 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 Uday Kumar |
Dr. Uday’s Advance Skin and Hair clinic |
#2637/6, First Floor, Begur Rd Near Canara Bank, Begur, Bengaluru, Karnataka
Bangalore
KARNATAKA |
6364147980
info@samahitha.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Beneficial for hair, Hair fall, Greying of hair and Dandruff |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimson Coconut Jasmine Oil, Reference: NA, Route: Oral, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: , Route: , Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: 28 Days, Reference: , Route: , Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aged between 18 to 65 years.
2. Subjects who willing to give written informed consent and ready to comply with the protocol.
3. Subjects with active alopecia, premature greying of hair - seborrheic dermatitis of the scalp – “Total ASFS Score ≥ 16
4. Subjects with a minimum hair length of 2 inches and willing to maintain the same minimum length,
hair style until the end of the study. |
|
| ExclusionCriteria |
| Details |
1. Subjects on topical treatment for alopecia, premature graying of the hair and seborrheic
dermatitis for 8 weeks prior to enrollment.
2. Subject with other dermatological disorders of the scalp that might interfere with the study
evaluation.
3. Subjects with significant scalp scarring.
4. Subjects who have anemia or iron deficiency.
5. Subjects who have previously undergone hair transplantation procedures.
6. History of systemic or cutaneous malignancy or evidence of immunocompromised state.
7. Subjects with history of skin allergy.
8. Subjects on systemic steroids for more than 14 days within 2 months prior to enrollment.
9. Female subjects who are reported pregnant/planning a pregnancy or lactating.
10. Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrollment.
11. Subjects, who in the opinion of the Investigator or the Expert Dermatologist are not eligible for enrollment in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Excellent reduction in the shedding range of the hair in the “60 Second Hair Comb testâ€
from visit 1 to the end of the study.
• Excellent reduction in the flaking severity in the “Adherent Scalp Flaking Score†from visit 1 to the end of the study. |
Day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Reasonable improvement in the “Subjective Hair Assessment Questionnaire†score from visit 1 to end of the study.
• Reasonable improvement the “Subject IP Feedback Questionnaire†score from Visit 2 to end of study. |
Day 42 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
04/07/2023 |
| Date of Study Completion (India) |
27/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a prospective, single arm, open label, single centre clinical study to evaluate the safety and efficacy of Nimson Amla oil with Vitamin C in benefitting the hair growth, reducing hairfall, greying of hair and dandruff.
Primary Objective • Reduction in the shedding range of the hair in the “60 sec Hair comb test†from Visit 1 to the end of the study. • Reduction in the “Adherent Scalp Flaking Score†from Visit 1 to the end of the study.
Secondary Objective • Reasonable improvement in the “Subjective Hair Assessment Questionnaire†score from Visit 1 to the end of the study. • Reasonable improvement the “Subject IP Feedback Questionnaire†score from Visit 2 to end of the study. |