| CTRI Number |
CTRI/2023/06/054313 [Registered on: 22/06/2023] 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 Kesh silk Plus oil in controlling hairfall and premature greying |
|
Scientific Title of Study
|
A Prospetive, single arm, open label, single centre clinical study to evaluate the safety and efficacy of Nimson kesh silk plus oil in controlling hairfall and premature greying |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2301 Ver 1 dated 1 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.
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 |
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 |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimson Kesh Silk Plus 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 (Baldness) and Palitya
(premature Greying) 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 |
Signs of allergy, irritation or intolerance to the components
of the test product
Patients who have been diagnosed to have local disease like
Alopecia areata, Alopecia totalis, Tinea capitis, Folliculitis
devaculans.
Patient with hair fall related to any Systemic disorders, any
Hormonal disorders, Post CA treatments and Vitiligo.
Pregnancy or lactation.
Participation in other clinical trials.
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 |
• Reduced hairfall as per the 60 seconds hairfall on Day 28 when compared with the baseline value
• Improvement in the Greying Severity score in comparison with the baseline |
day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Increase in hair length to establish the ability of the oil to Nourish the hair.
• Number of subjects experiencing eye or skin irritation or any adverse events in the treatment phase. |
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)
|
03/07/2023 |
| 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 an prospective , single arm,open label, single centre clinical study to evaluate the safety and efficacy of Nimson Keshsilk Plus oil in Controlling Hair fall and premature greying
Primary Objective : • Prevention or control of premature greying of hair • Reduced hair fall ensuring thicker and stronger hair growth.
Secondary Objective : • To test the ability of the test product to nourish the hair measured by measuring the length and strand |