| CTRI Number |
CTRI/2023/06/054302 [Registered on: 22/06/2023] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| 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 coconut jasmine oil with Vitamin E in improving hair growth |
|
Scientific Title of Study
|
A Prospective, Single arm, Open label, Single centre Clinical study to evaluate the Safety and Efficacy of Nimson Coconut Jasmin oil with Vitamin E in improving Hair Growth. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2302 Version 1.0 Dated 8 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. 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 |
Room No.2, Department of Clinical Operations No 1204 ASHVA second floor 26th main road Jayanagar 9th block Bangalore KARNATAKA 560069 India
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-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
Bangalore
KARNATAKA |
6364147980
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 |
Keshya |
|
|
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: 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 |
•Subjects aged between 18 to 65 years.
• Patients having Khalitya (Hair fall) as per Ayurvedic classical texts and as per modern parameters i.e., Hair fall, Dandruff and Dryness of hairs have been selected irrespective of any bar of caste, gender, religion and occupation. |
|
| ExclusionCriteria |
| Details |
1)Signs of allergy, irritation or intolerance to the components of the test product
2)Patients who have been diagnosed to have local disease like Alopecia areata, Alopecia totalis, Tinea capitis, Folliculitis devaculans.
3)Patient with hair fall related to any Systemic disorders, any Hormonal disorders, Post CA treatments and Vitiligo.
4)Pregnancy or lactation.
5)Participation in other clinical trials.
6)Unwilling/unable to sign the informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To test the Efficacy of the coconut jasmine oil with vitamin E in increasing the hair growth and repairing damaged hair. |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Adverse events & its percentage
• Treatment discontinuation rates: Early discontinuation, discontinuation due to adverse events |
42 days |
|
|
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)
|
30/06/2023 |
| 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="2"
Months="0"
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
|
A prospective ,single arm, open label, single centre clinical study to evaluate the safety and efficacy of Nimson coconut jasmin oil with vitamin E in improving hair growth.
Primary Objective : To evaluate the capacity of Nimson coconut jasmine oil to nourish the hair evaluated by change in investigator assessment score for hair count and percentage of subjects responding to therapy.
Secondary Objective • To test the efficacy of the coconut jasmine oil with Vitamin E .in the nourishment of the scalp . • Frequency of the adverse events |