| CTRI Number |
CTRI/2026/03/106182 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical study on the effectiveness of Varnanai Chooranam and Varnanai Chooranam with Siddhar Yoga in treating obesity |
|
Scientific Title of Study
|
AN OPEN LABELLED DOUBLE ARM NON RANDOMISED PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY OF VARNANAI CHOORANAM (INTERNAL MEDICINE) AND VARNANAI CHOORNAM (INTERNAL MEDICINE) WITH SIDDHAR YOGA MARUTHUVAM IN THE MANAGEMENT OF ATHIHOOLA NOI (OBESITY) |
| 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 AISWARYA B |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI TIRUNELVELI TAMILNADU INDIA 627002 |
| Address |
SECOND YEAR
DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM
GOVERNMENT SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI TIRUNELVELI INDIA 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7708460962 |
| Fax |
|
| Email |
aiswaryasiddha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mahalakshmi MD Siddha |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI TIRUNELVELI TAMILNADU INDIA 627002 |
| Address |
PROFESSOR AND HOD DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI TIRUNELVELI TAMILNADU INDIA 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9942061169 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Mahalakshmi MD Siddha |
| Designation |
PROFESSOR and HOD |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI |
| Address |
PROFESSOR AND HOD DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI TIRUNELVELI
TAMIL NADU
627002
India |
| Phone |
9942061169 |
| 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 TAMILNADU INDIA 627002 |
|
|
Primary Sponsor
|
| Name |
Dr AISWARYA B |
| Address |
SECOND YEAR DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI 627002 |
| 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 AISWARYA B |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI |
DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI
Tirunelveli
TAMIL NADU |
7708460962
aiswaryasiddha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE - Govt siddha medical College and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E668||Other obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
VARNANAI CHOORANAM |
ORAL ADMINISTRATION OF 2 G OF VARNANAI CHOORANAM WITH LUKE WARM WATER TWICE A DAY FOR A DURATION OF 48 DAYS |
| Comparator Agent |
VARNANAI CHOORANAM WITH SIDDHAR YOGA MARUTHUVAM |
ORAL ADMINISTRATION OF 2 G OF VARNANAI CHOORANAM WITH LUKE WARM WATER TWICE A DAY ALONG WITH THE PRACTICE OF SIDDHAR YOGA MARUTHUVAM FOR A DURATION OF 48 DAYS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with Athithoola Noi (Obesity) based on Siddha and WHO criteria (BMI more are equal 25 kg/m² for Asian adults).
Grade 1 or overweight 25 to 30 kg/m²
Grade2 or obesity. 30 to 40 kg/m²
CRP level more 3 mg/L (elevated low-grade inflammation).
Willing to follow Yoga therapy and take Siddha internal medicine (as per allocated group).
Ability to provide informed consent
Physically fit to perform basic yoga asanas.
Willing to attend regular follow-up and assessments
Patient who are willing for admission and stay in IPD or willing to attend OPD. |
|
| ExclusionCriteria |
| Details |
Irregular yoga practice during the intervention
CRP higher than 10mg / L
H/o disease that affect lipid profile and serum levels of CRP ( Hyperthyroidism ,malabsorption syndrome,liver disease,TB,HIV,Malignancies)
Using medications that affect lipid profile and serum levels of CRP
Individuals with morbid obesity (BMI more or equal 40 kg/m²).
Pregnant or lactating women.
History of severe systemic illness (cardiac, hepatic, renal, or malignancy).
Known allergy or intolerance to any ingredient in Varnanai Chooranam.
On long-term steroids, immunosuppressants, or anti-obesity medications.
Practicing yoga or herbal therapies regularly for the past 6 months.
Any psychiatric disorder that impairs compliance.
Participation in another clinical trial within the last 3 months
Persons who are following intermittent fasting
Gym going persons.
Thyroid disorder
Females under hormonal therapy for Menstrual disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Through this trial, the therapeutic effectiveness of the trial drug and Siddhar Yogam Maruthuvam towards the management of Athithoola noi ( obesity) l can be manifested.
Change in Serum C-Reactive Protein (CRP) levels before and after 48 days of intervention, comparing both groups. |
Baseline(0th day) and the end of the
intervention period (48th day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Body Mass Index (BMI) – measured in kg/m².
Reduction in Waist and Hip Circumference – using standard anthropometric tools.
Change in Fatigue Severity Score (FSS) – subjective scale assessment of fatigue levels...
Changes in Siddha Parameters:
Nadi (Pulse) diagnosis
Udal Thath uk kal balance |
Baseline(0th day) and the end of the intervention period (48th 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)
|
24/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
It is an open labelled double arm non randomised phase II clinical trial to evaluate the efficacy of
Varnanai Chooranam and Varnanai Chooranam with Siddhar Yoga Maruthuvam Group A will be given oral administration of 2 gm of Varnani Chooranam (Internal medicine) with
Luke warm water twice a day for a duration of 48 days
Group B also be given oral administration of 2 gm of Varnani Chooranam with Luke warm water
along with the practice of Siddhar Yoga Maruthuvam for a duration of 48 days |