| CTRI Number |
CTRI/2023/09/058172 [Registered on: 29/09/2023] Trial Registered Prospectively |
| Last Modified On: |
12/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of Hair mist on hair repigmentation |
|
Scientific Title of Study
|
Randomized placebo controlled single blind pilot clinical study to evaluate efficacy of herbal hair mist in hair re-pigmentation and the hair growth in healthy volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sheetal Chavan |
| Designation |
Assistant Professor Rognidan |
| Affiliation |
Ayurved Seva sangh ayurved mahavidyalaya nashik |
| Address |
Ayurved Seva Sangh Ayurved Mahavidyalaya, Ganeshwadi,Panchavati,Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9272642873 |
| Fax |
|
| Email |
dr.sheetalyadav59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh D. Laddha |
| Designation |
Assistant Professor |
| Affiliation |
METs institute of pharmacy |
| Address |
METs institute of pharmacy Bhujbal knowledge city Adgaon Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9823611436 |
| Fax |
|
| Email |
umeshladdha698@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shishir Pande |
| Designation |
Professor Rasashastra |
| Affiliation |
Ayurved Seava sangh ayurved mahavidyalaya Nashik |
| Address |
Ayurved Seva Sangh Ayurved Mahavidyalaya, Ganeshwadi,Panchavati,Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9420830818 |
| Fax |
|
| Email |
shishir.nsk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Arogyashala Rugnalaya Ganeshwadi Panchavati Nashik 422003 |
| Dr.Umesh D. Laddha
METs Institute of Pharmacy
Bhujbal Knowledge City Adgaon Nashik 422003 |
|
|
Primary Sponsor
|
| Name |
Regeron Inc. |
| Address |
Regeron Inc., Chuncheon, Gangwon-Do, South Korea-24253 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Sheetal Chavan |
Arogyashala Rugnalaya, Ganeshwadi , Nashik. |
OPD no 9 Sanshodhan OPD
Nashik
MAHARASHTRA |
9272642873
dr.sheetalyadav59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ayurved Mahavidyalaya Nasik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects having gray hair |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Herbal Hair Mist, Reference: NA, Route: Topical, Dosage Form: Sprays, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: 2.5 % concentration | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | 2 ml twice daily after bath for 90 days | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Herbal Hair Mist, Reference: NA, Route: Topical, Dosage Form: Sprays, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: 1.5 % concentration |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Presence of gray hairs
Person willing to sign an informed consent
Person ready to stop application of any hair color or dye 15 days prior to treatment and throughout the treatment.
Person with normal hemoglobin count
Either male or female |
|
| ExclusionCriteria |
| Details |
Person suffering from any life-threatening disease/disorder.
Person not willing to come for follow-up when required.
Person who is part of any other clinical trial.
Person having any allergy to included ingredients.
Other conditions which in opinion of the investigator make subject unsuitable for study.
Female with pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in hair color from white to original color.
Safety assessment |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stimulation of hair growth |
90 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/10/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The purpose of this study is to check ability of prepared herbal formulation in change in hair color of ‘grey hair’ by photographic and questions based response of subject. Formulation application is topical. No any systemic investigation. Based on above assumption and considering the 20% dropout rate, we proposed to enroll 72 subjects as 36 in each group to get 60 cases (each group 30) at the end of study. Further each group will be divided in two sub groups based on the age as 20-40 and 41-60 years. Henceforth final groups for the study; | Group | Age | Treatment | No. of subjects | | I | 20-40 | Formulation | 18 | | II | 41-60 | Formulation | 18 | | III | 20-40 | Placebo | 18 | | IV | 41-60 | Placebo | 18 | Frequency of application: twice in a day |