| CTRI Number |
CTRI/2023/05/053336 [Registered on: 31/05/2023] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
An open labelled double arm non randomized phase II clinical trial to evaluate the efficacy of siddhar yoga muraigal and inji thean in the management of athithoolam(Obesity) |
|
Scientific Title of Study
|
AN OPEN LABELLED DOUBLE ARM NON RANDOMIZED PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY OF SIDDHAR YOGA MURAIGAL AND INJI THEAN IN THE MANAGEMENT OF ATHITHOOLAM(OBESITY) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr O S Kayalvizhi |
| Designation |
PG Scholar |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
II year PG scholar,Department of Siddhar Yoga Maruthuvam,Government Siddha Medical College and Hospital,Palyamkottai,Thirunelveli district .
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8148348957 |
| Fax |
|
| Email |
elsykayal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A S Poongodi Kanthimathi |
| Designation |
Professor |
| Affiliation |
Government siddha medical college and hospital |
| Address |
HOD,Department of siddhar yoga Maruthuvam,Government siddha medical college and hospital,Palyamkottai. Thirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9865105356 |
| Fax |
|
| Email |
arunapriya1995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A S Poongodi Kanthimathi |
| Designation |
Professor |
| Affiliation |
Government siddha medical college and hospital |
| Address |
HOD,Department of siddhar yoga Maruthuvam,Government siddha medical college and hospital,Palyamkottai. Thirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9865105356 |
| Fax |
|
| Email |
arunapriya1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Central library of Government Siddha Medical College and Hospital. |
|
|
Primary Sponsor
|
| Name |
Dr O S Kayalvizhi |
| Address |
II year PG scholar,Department of Siddhar Yoga Maruthuvam,Government siddha medical college and hospital, Playamkottai,Thirunelveli. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrOSKayalvizhi |
Government siddha medical college and hospital, Palayamkottai |
Government siddha medical college and hospital, Palayamkottai, Tirunelveli 627002
Tirunelveli
TAMIL NADU |
8148348957
elsykayal@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: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inji Thean (Intetnal medicine) |
Inji thean 1 teaspoon twice a day for 48 days |
| Intervention |
Siddhar yoga maruthuva muraigal with Inji Thean(Internal medicine) |
Yoga theraphy and Inji thean 1 teaspoon internally for 48 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with BMI above 23.
Patients who are willing to participate in the study.
Patients who are willing to sign the informed consent. |
|
| ExclusionCriteria |
| Details |
Age-Below 18 years and above 60 years.
Patients who face difficulties or hesitate to practice yoga.
Patients with uncontrolled hypertension.
Pregnancy and lactation.
Drug addicts.
Neurological disease.
Coronary disease.
History of fracture within one year.
Bronchial asthma.
Inflammatory joint disease.
Patients who are refused to sign the consent form. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of beneficial effect of Siddhar yogam and Inji Thean in management of Athithoolam(Obesit
y) |
48days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
08/06/2023 |
| Date of Study Completion (India) |
17/08/2024 |
| Date of First Enrollment (Global) |
08/06/2023 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
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 a open labelled double arm non randomized phase II clinical trial to evaluate the efficacy of Siddhar Yoga Maruthuva Muraigal and Inji thean (Internal medicine) in the management of athithoolam(obesity). INJI THEAN. Dosage-1 teaspoon twice a day. Along with Siddhar Yoga Maruthuva muraigal. |