| CTRI Number |
CTRI/2026/02/104766 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the efficacy of kudasappalai pattai chooranam and kudasappalai pattai chooranam with siddhar yoga Maruthuva muraigal in the management of neerizhivu ( Type II diabetes mellitus) |
|
Scientific Title of Study
|
An open labelled double arm non randomized phase II clinical trial to evaluate the efficacy of kudasappalai pattai chooranam and kudasappalai pattai chooranam with siddhar yoga Maruthuva muraigal in the management of neerizhivu (Type II 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 VASUNDIRA K S |
| 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
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8270737339 |
| Fax |
|
| Email |
vasundira1311@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR M SANKARA RAMA SUBRAMANIAN MD Siddha |
| Designation |
Lecturer grade ll |
| Affiliation |
Government siddha medical College and hospital Palayamkottai |
| Address |
Lecturer grade ll Department of Siddhar Yoga Maruthuvam Government siddha medical College and hospital Palayamkottai Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443465683 |
| Fax |
|
| Email |
srmsrs2873@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR V MAHALAKSHMI MD Siddha |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical College and hospital Palayamkottai |
| Address |
Professor and HOD Department of Siddhar Yoga Maruthuvam Government siddha medical College and hospital Palayamkottai tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9942061169 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr VASUNDIRA K S |
| 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 K S VASUNDIRA |
Government siddha medical College and hospital Palayamkottai |
Department of Siddhar Yoga Maruthuvam Government siddha medical College and hospital Palayamkottai
Tirunelveli
TAMIL NADU |
8270737339
vasundira1311@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Government siddha medical College |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kudasappalai pattai chooranam (internal medicine) |
Oral administration of 1-2 gms of kudasappalai pattai chooranam with Luke warm water twice a day for a duration of 48 days |
| Comparator Agent |
Kudasappalai pattai chooranam with siddhar yoga Maruthuva muraigal |
Oral administration of 1-2 gms of kudasappalai pattai chooranam with Luke warm water twice a day along with the practice of Siddhar Yoga Maruthuva muraigal(Yogasanas) for the duration of 48 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of non-insulin dependent diabetes mellitus with symptoms of poluria polydipsia and polyphagia
Blood glucose level (Fasting above 126 mg/dl and below 250 mg/dl or post prandial above 200 mg/ dl and below 350 mg/dl )
HBA1C - 6.5% to 10 % |
|
| ExclusionCriteria |
| Details |
Patients with diabetic complications such as diabetic foot, nephropathy, neuropathy and retinopathy
Insulin dependent diabetes mellitus
Any other serious chronic systemic illness related to heart and lungs etc
Pregnancy and lactation
Diabetes insipidus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study aims at bringing light on the efficacy of the long standing traditional practice of kudasappalai pattai chooranam and siddhar yoga Maruthuva muraigal towards the management of neerizhivu (Type ll diabetes mellitus) |
Baseline ( 0 th day ) and the end of the intervention period ( 48 th day ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The positive impact of yoga in the management aspect maybe be highlighted through this study |
Baseline ( 0 th day ) and the end of the intervention period ( 48 th 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)
|
08/03/2026 |
| 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 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
|
It is an open labelled double arm non randomized phase ll clinical trial to evaluate the efficacy of kudasappalai pattai chooranam and kudasappalai pattai chooranam with siddhar yoga Maruthuva muraigal in the management of neerizhivu ( Type II diabetes mellitus) Group A will be given oral administration of 1-2 gms of kudasappalai pattai chooranam ( internal medicine) with Luke warm water twice a day for a duration of 48 days Group B will be given oral administration of 1- 2 gms of kudasappalai pattai chooranam( internal medicine) with Luke warm water twice a day along with the practice of Siddhar Yoga Maruthuva muraigal ( Yogasanas) for the duration of 48 days |