| CTRI Number |
CTRI/2026/01/100390 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Apan Mudra as an Add on Therapy in the Management of Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
An Interventional Study To Evaluate Add On Effect of Apan Mudra in the Management of Type 2 Diabetes Mellitus |
| 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 Onkar Ashok Gaikwad |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Reasearch Centre Kodoli Kolhapur |
| Address |
Department Swasthavritta OPD no 32 Yashwant Ayurvedic college Post Graduate Training and Research Centre Kodoli Tq Panhala Kolhapur Maharashtra 416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9921598612 |
| Fax |
|
| Email |
onkargaikwad9765@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milind Mohan Godbole |
| Designation |
Professor and Dean |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Kolhapur |
| Address |
Dean Office Ground floor Yashwant Ayurvedic college Post Graduate Training and Research Centre Kodoli Tq Panhala Kolhapur Maharashtra 416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9850119900 |
| Fax |
|
| Email |
drmilindgodbole@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milind Mohan Godbole |
| Designation |
Professor and Dean |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Kolhapur |
| Address |
Dean Office Ground floor Yashwant Ayurvedic college Post Graduate Training and Research Centre Kodoli Tq Panhala Kolhapur Maharashtra 416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9850119900 |
| Fax |
|
| Email |
drmilindgodbole@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic college Post Graduate Training and Research Centre Kodoli Tq.Panhala Kolhapur Maharashtra 416114 India |
|
|
Primary Sponsor
|
| Name |
Dr Onkar Ashok Gaikwad |
| Address |
Department Swasthavritta OPD no 32 Yashwant Ayurvedic college Post Graduate Training and Research Centre Kodoli Tq. Panhala Kolhapur Maharashtra 416114 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 Onkar Ashok Gaikwad |
Yashwant Ayurvedic college Post Graduate Training and Research Centre Kodoli Kolhapur |
Department Swasthavritta OPD no 32 Yashwant Ayurvedic college Post Graduate Training and Research Centre Kodoli Kolhapur Maharashtra 416114 India
Kolhapur
MAHARASHTRA |
9921598612
onkargaikwad9765@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yashwant Ayurvedic College Kodoli Kolhapur Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Apan Mudra | (Procedure Reference: Gheranda Samhita , Procedure details: Formation of Mudra by joining the tips of thumb, middle finger & ring finger together.keep other two fingers relaxed & straight. Mudra is practiced for 15 minutes per session thrice daily for 12 weeks.)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Age between 30-65 years
2)Diagnosed case of Type 2 Diabetes Mellitus with HbA1c between 7%- 9%.
3)Willing to comply with Mudra practice for 12 weeks provided written informed consent. |
|
| ExclusionCriteria |
| Details |
1) patient with chronic complications of diabetes (nephropathy,neuropathy,retinopathy)
2) severe psychiatric,cardiac,hepatic,renal disorders,pregnant or lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HbA1c measure |
Assessment on 0th week and 12 th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life - assessed by WHOQOL-BREF questionnaire ( pre and post) |
WHOQOL-BREF questionnaire measured at baseline (0 weeks) and after 12 weeks |
| Subjective symptom score- check list of common diabetes symptoms like fatigue,thrist, polyuria,etc |
Subjective symptom score-measured at baseline (0 weeks) and after 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2026 |
| 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="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 study evaluates the add-on effect of Apan Mudra in the management of Type two Diabetes Mellitus rooted in Ayurvedic concept of Madhumeha, the study explores how regular practice of Apan Mudra a simple Yogic hand gesture may help improve glycemic control by balancing Apan Vayu ,enhancing Agni, reducing Ama ,lowering stress and improving insulin sensitivity . It is a single arm interventional clinical study involving 64 Type 2 Diabetes mellitus patients, conducted over 12 weeks, alongside standard medical treatment. Primary outcomes include changes in HbA1c while secondary outcomes assess quality of life and symptoms improvement. |