| CTRI Number |
CTRI/2023/06/054294 [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 Red Onion oil in Patients with Dandruff and Hairfall. |
|
Scientific Title of Study
|
A prospective, single arm, open label, single centre clinical study to evaluate the safety and efficacy of Red Onion oil in dandruff and hairfall control. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2306 Version 1.0 dated 20 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
Bangalore
KARNATAKA |
6364147989
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 |
Dandruff and Hairfall |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Red Onion 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 |
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 |
• Change in mean percentage of hair fall, that is reduction after 2nd & 4th week of
application using 60 seconds hair count technique
• Reduction in the premature greying of hair .
• To assess the effect of Red onion oil in terms of change in hair growth on the scalp .
|
2nd & 4th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To evaluate the effectiveness of Red onion oil in reduction of dandruff by using Adherent
scalp flaking score , dryness & controlling excessive frizz |
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)
|
29/06/2023 |
| Date of Study Completion (India) |
11/08/2023 |
| 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)
|
Completed |
| 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 red onion oil in dandruff and hairfall control.
Primary Objective • To evaluate the reduction in the hair fall ensuring thicker and stronger growth . • To evaluate the reduction in the premature greying of hair
Secondary Objective • To evaluate the prevention of dandruff , dryness and controlling excessive frizz |