| CTRI Number |
CTRI/2025/12/099208 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
14/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Facial Yoga Protocol] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Developing and validating a new Facial Yoga Protocol to reduce signs of facial aging and assessing it in a single arm study in healthy individuals. |
|
Scientific Title of Study
|
Development and Validation of a Facial Yoga Protocol for Anti-Aging: Assessment of Its Effectiveness w. s. r. to FARE Scale in a Single Arm Pre-Post Interventional Study. |
| 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 Bharti Bhaskar Kapgate |
| Designation |
BAMS MD Scholar |
| Affiliation |
Government Ayurved College and Hospital Nagpur |
| Address |
OPD no 6 Swastharakshan Department Government Ayurved College and Hospital Sakkardara square Raje Raghuji Nagar Nagpur 440022 Maharashtra India
OPD no 6 Swastharakshan Department Government Ayurved College and Hospital Sakkardara square Raje Raghuji Nagar Nagpur 440022 Maharashtra India
Nagpur
MAHARASHTRA
440022
India |
| Phone |
9881227461 |
| Fax |
|
| Email |
bhartikapgate1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjiri V Bhende |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College and Hospital Nagpur |
| Address |
Government Ayurved College and Hospital Sakkardara square Raje Raghuji Nagar Nagpur 440022 Maharashtra India
Government Ayurved College and Hospital Sakkardara square Raje Raghuji Nagar Nagpur 440022 Maharashtra India
Nagpur
MAHARASHTRA
440022
India |
| Phone |
9373127925 |
| Fax |
|
| Email |
manjiri.palnitkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharti Bhaskar Kapgate |
| Designation |
BAMS MD Scholar |
| Affiliation |
Government Ayurved College and Hospital Nagpur |
| Address |
OPD no 6, Swastharakshan Department Government Ayurved College and Hospital Sakkardara square Raje Raghuji Nagar Nagpur 440022 Maharashtra India
OPD no 6, Swastharakshan Department Government Ayurved College and Hospital Sakkardara square Raje Raghuji Nagar Nagpur 440022 Maharashtra India
Nagpur
MAHARASHTRA
440022
India |
| Phone |
9881227461 |
| Fax |
|
| Email |
bhartikapgate1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Periphery of Government Ayurved College and Hospital Nagpur (recruited under OPD 6 of Government Ayurved Hospital Nagpur) Pincode-440024, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Bharti Bhaskar Kapgate |
| Address |
OPD no 6, Swastharakshan Department, Government Ayurved College and Hospital, Sakkardara square, Raje Raghuji Nagar, Nagpur 440022 Maharashtra India |
| Type of Sponsor |
Other [Self ] |
|
|
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 Bharti B Kapgate |
Government Ayurved College and Hospital, Nagpur |
OPD 6, Swastharakshan Department, Government Ayurved College and Hospital, Sakkardara square, Raje Raghuji nagar, Nagpur, Maharashtra
Nagpur
MAHARASHTRA |
09881227461
bhartikapgate1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurvedic College, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers having their facial age more than their chronological age. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Newly Developed and Validated Facial Yoga Protocol will be implemented as an Intervention in healthy individuals, who will be instructed to practice this daily for 45-50 minutes for a period of 8 weeks., Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
31.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy volunteers aged between 31 to 60 years.
2.Willing to participate in the study and provide written informed consent.
3.Individual having a predicted age greater than their chronological age atleast by 6 months (as estimated by the FARE Scale Linear Regression Formula at the time of screeing). |
|
| ExclusionCriteria |
| Details |
1.Individual with any known dermatological conditions (e.g. eczema, psoriasis, vitiligo) affecting the face.
2.Individual currently undergoing any cosmetic or anti-aging treatments (e.g. botox, retinoids, chemical peels).
3.Individual with systemic illnesses like diabetes mellitus, hypertension, thyroid disorders or autoimmune condition.
4.Individual taking medications that affect skin health (e.g. corticosteroids, hormonal therapy, isotretinoin).
5.Individual currently practicing any form of Yoga regularly (including facial Yoga, general Yoga classes or pranayama)
6.Individual who has undergone any facial surgery or laser procedures in the past 6 months.
7.Individual currently participating in another clinical trial.
8.Women who are pregnant. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To develop a structured facial Yoga protocol including asana’s, pranayama’s, mudra’s with specific duration and frequency.
2)To validate the developed facial Yoga protocol through the experts.
3)To compare the facial aging assessed by FARE scale in healthy volunteers before and after practicing the newly developed and validated facial Yoga protocol for 8 weeks.
|
At baseline, 30th day and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/03/2026 |
| 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="1"
Months="0"
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
|
In today’s era, people undergo various treatments and surgical procedures to look younger, which are expensive and invasive. This study aims to develop and validate a structured Facial Yoga Protocol consisting of specific asana’s, pranayama’s and mudra’s for reducing facial aging in healthy individuals. Also, this study will assess the effectiveness of the developed and validated Facial Yoga Protocol in a Single Arm Pre-Post Interventional study on facial aging parameters of healthy individuals of 31-60 years of age using Facial Aging Rating Evaluation (FARE) Scale. |