| CTRI Number |
CTRI/2025/08/093246 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Siddhar yogic mudras (Hand gestures) for stress management - a case series for 20 participants |
|
Scientific Title of Study
|
A DESCRIPTIVE STUDY OF SIDDHAR YOGIC MUDRAS (HAND GESTURES) FOR STRESS MANAGEMENT - A CASE SERIES OF OPD, GSMCH, PALAIYAMKOTTAI, TIRUNELVELI DISTRICT, TAMILNADU |
| Trial Acronym |
Siddhar yogic Mudras trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR S SATHISH KUMAR |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
SECOND YEAR, DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM,
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8778769094 |
| Fax |
|
| Email |
sathishkumar17121998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR S SATHISH KUMAR |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
SECOND YEAR, DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM,
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8778769094 |
| Fax |
|
| Email |
sathishkumar17121998@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR V MAHALAKSHMI MD SIDDHA |
| Designation |
PROFESSOR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
HEAD OF THE DEPARTMENT, DEPARTMENT OF SIDDHAR YOGA
MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8248818479 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD AND IPD FACILITIES AND CENTRAL LIBRARY OF GOVERNMENT SIDDHA MEDICAL
COLLEGE AND HOSPITAL, PALAYAMKOTTAI. |
|
|
Primary Sponsor
|
| Name |
DR S SATHISH KUMAR |
| Address |
SECOND YEAR, DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM,
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI. |
| 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 S SATHISH KUMAR |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTA |
SECOND YEAR,
DEPARTMENT OF
SIDDHAR YOGA
MARUTHUVAM,
GOVERNMENT
SIDDHA MEDICAL
COLLEGE AND
HOSPITAL,
PALAYAMKOTTAI
Tirunelveli
TAMIL NADU |
8778769094
sathishkumar17121998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F430||Acute stress reaction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
SIDDHAR YOGIC MUDRAS |
CHIN MUDRA
CHINMAY MUDRA
SHANGU MUDRA
KAMALA MUDRA
ANJALI MUDRA
For 25-30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PSS score upto 35
If any 3 of the following symptoms of Stress are present, the participants will be included for the study.
Crying spells or bursts of anger.
Difficulty eating.
Losing interest in daily activities.
Increasing physical distress symptoms such as headaches or stomach pains.
Fatigue.
Feeling guilty, helpless, or hopeless.
Insomnia
Avoiding family and friends |
|
| ExclusionCriteria |
| Details |
• H/o Trauma in the Head.
• Psychiatric disease
• Pregnant women.
• H/o Cardiac disorders.
• PSS score more than 35
• Any other serious systemic illness. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Siddhar yogic mudras (Hand gestures) in the management of stress |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the stress management through PSS 10 scale |
45 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/08/2025 |
| Date of Study Completion (India) |
30/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Siddha medicine is a principle of medical methods that treat & prevents diseases with disproportionate values of vatha,pitha,kabha using medication & methodology from various raw material sources including plants,Animal & metals.In Siddha medicine, methods are given to strengthen not only the gross body but also the subtle body.Ashtanga yoga i.e. Iyama, Niyama and Asana plays a major role in this. Mudras play a special role in these asanas.Mudras are used to channel and heal energy in the body.In Siddha medicine the body is made up of pancha budhas, just as each of our fingers represents each budha(Ring finger - Earth, little finger- Water, Thumb finger - Fire, Index finger - Air and Middle finger -Space).Diseases occur in our body when the balance of pancha budhas changes in the body.We can use mudras to create balance between pancha budhas and cure diseases Stress is common for most people in this hectic time.Many activities in daily life cause stress to people.In Siddha medicine stress is caused by pitha imbalance in the body.When stress increases, various mental illnesses occur(like Depression, Bipolar disorder, Hypertension etc.).This causes problems like headache and insomnia. |