| CTRI Number |
CTRI/2023/06/054425 [Registered on: 26/06/2023] 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 Almond oil in patients with Dandruff and Hairfall control. |
|
Scientific Title of Study
|
A prospective, single arm, open label, single centre clinical study to evaluate the safety and efficacy of Nimson Almond oil in Dandruff and Hairfall control |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2303 Version 1.0 dated 13 May 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday Kumar S |
| Designation |
Principal Investigator |
| Affiliation |
Dr Udays Advance Skin and Hair Clinic |
| Address |
Dr. Uday’s Advance Skin and Hair clinic #2637/6, First floor, Begur Rd, Near Canara bank, Begur, Bengaluru.
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 |
No 1204 ASHVA second floor 26th main road Jayanagar 9th block Bangalore
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, Distt Solan, Himachal Pradesh-174101 |
|
|
Primary Sponsor
|
| Name |
Aryanveda Cosmeceuticals |
| Address |
128, Nalagarh bhartgarh road, VPO Rajpura, Near GPI textile pvt Ltd, Tehsil Nalagarh, Distt Solan, Himachal Pradesh-174101 |
| 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 560068
Bangalore
KARNATAKA |
6364147989
info@samahitha.com |
|
|
Details of Ethics Committee
|
| 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 |
Dandruff and Hair fall Control |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimson Almond Oil , Reference: NA, Route: Topical, 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, 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 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.
• Excellent reduction of dandruff & itching of scalp. |
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 in 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) |
15/08/2023 |
| 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
|
This study is a prospective, single arm, open label, single centre clinical study to evaluate the safety and efficacy of Nimson Almond oil in Dandruff and Hairfall control.
. Primary Objective • Reduction in the hair fall from Visit 1 to the end of the study. • Reduction in the dandruff flakes and itching of the scalp.
Secondary Objective • Improvement in the subjective hair assessment questionnaire. • Improvement in the IP feedback questionnaire from visit 2 to end of the study |