| CTRI Number |
CTRI/2025/04/085864 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the effect of Thirumoolar Pranayamam as an add-on treatment with Kadukkai Karpam in the management of Viyagula Unmatham with special reference to Depression. |
|
Scientific Title of Study
|
An open-labelled, double-arm, Phase II clinical trial to evaluate the effectiveness of Kadukkai Karpam and Kadukkai Karpam with Thirumoolar Pranayamam in the management of Viyagula Unmatham with special reference to Depression. |
| 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 M Karthikeyan |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
PG Second year, Department of Siddhar Yoga Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9688453508 |
| Fax |
|
| Email |
drkarthikeyan1406@gmail.com |
|
Details of Contact Person
Scientific 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, Palayamkottai, Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8248818479 |
| Fax |
|
| Email |
drmahalakshmi67@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, Palayamkottai, Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8248818479 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
|
Source of Monetary or Material Support
|
| The OPD and IPD facilities and Central library of Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli 627002, Tamilnadu, India. |
|
|
Primary Sponsor
|
| Name |
Dr M Karthikeyan |
| Address |
PG second year, Department of Siddhar Yoga Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli 627002, Tamilnadu, 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 M Karthikeyan |
Government Siddha Medical College and Hospital, Palayamkottai |
Department of Siddhar Yoga Maruthuvam, Government Siddha Medical College, Palayamkottai, Tirunelveli.
Tirunelveli
TAMIL NADU |
9688453508
drkarthikeyan1406@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002, Tamilnadu, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kadukkai Karpam (Internal Medicine) |
Kadukkai karpam is powdered form of Kadukkai (Fruit of Terminalia chebula of Combretaceae family)
Oral administration
of 3 grams of medicine once a day in evening time with water for a duration of 45 days
|
| Comparator Agent |
Kadukkai Karpam (Internal Medicine) with Thirumoolar Pranayamam (Siddhar Thirumoolar Breath Technique) |
Oral administration of 3 grams of medicine once a day in evening time with water along with practice of Thirumoolar Pranayamam technique for a duration of 45 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Hamilton Depression Rating Scale (HAMD-17) score of 18 or more
2. Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 45 days but can opt out of the trial of his/her own conscious discretion.
|
|
| ExclusionCriteria |
| Details |
1. Any co morbid psychiatric illness especially bipolar depression, schizophrenia or dementia
2. Suicidal intent or any other psychiatric emergency
3. Evidence of other medical comorbidity that could substantially influence depression or has an effect on cognition and behavior
4. History of alcohol or drug abuse over the last 6 months
5. Anti-epileptic drugs
6. Pregnancy or Post-partum women.
7. Acute infectious diseases
8. Ongoing current practice of yoga or any other mind-body techniques.
9. Pre existing Cardiac illness, severe lung illness.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the trial will be reduction in depressive symptoms, assessed using a validated depression rating scale such as PHQ-9 questionnaire from baseline to the end of the intervention period. |
Baseline (0th day) and at the end of the intervention period (45th day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This research explores the potential synergistic benefits of Thirumoolar Pranayamam as an addon intervention with Kadukkai Karpam in enhancing therapeutic outcomes of Viyagula Unmatham with special reference to depression. |
Baseline (0th day) and the end of the intervention period (45th day) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
13/05/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
It is an open labelled double arm Randomized phase ll clinical trial to evaluate the effectiveness of Kadukkai karpam (Internal Medicine) and Kadukkai Karpam (Internal Medicine) with Thirumoolar Pranayamam (Siddhar Thirumoolar Breath Technique). Group A will be given oral administration of 3 grams of internal medicine Kadukkai karpam once a day in evening time with water and Group B will also be given Oral administration of 3 grams of medicine once a day in evening time with water along with practice of Thirumoolar Pranayamam technique for a duration of 45 days |