| CTRI Number |
CTRI/2025/05/087234 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
An open labelled double arm non randomised phase II clinical trial to evaluate the efficacy of keezhkai nelli podi and keezhkai nelli podi with siddhar yoga maruthuva muraigal in the management of
Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
AN OPEN LABELLED DOUBLE ARM NON RANDOMIZED PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY OF KEEZHKAI NELLI PODI AND KEEZHKAI NELLI PODI WITH SIDDHAR YOGA MARUTHUVA MURAIGAL IN THE MANAGEMENT OF MADHUMEGAM (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 MPackia Lakshmi |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical College and hospital, Palayamkottai |
| Address |
II year pg scholar, Department of siddhar yoga maruthuvam, Government siddha medical College and hospital, Palayamkottai, Tirunelveli, Tamilnadu 627002 India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
6369360237 |
| Fax |
|
| Email |
bhakiyamalathi@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 , Tamilnadu 627002 India
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 , Tamilnadu 627002 India
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 edical College and Hospital , Palayamkottai- 627002, Tirunelveli, Tamilnadu,India. |
|
|
Primary Sponsor
|
| Name |
Dr M Packia Lakshmi |
| Address |
Second year pg scholar, Department of siddhar yoga maruthuvam, Government siddha medical College and hospital, Palayamkottai, Tirunelveli, Tamilnadu 627002 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 PACKIA LAKSHMI |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL |
4B, SECOND YEAR PG SCHOLAR,DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,PALAYAMKOTTAI 627002 Tirunelveli Tamilnadu India
Tirunelveli
TAMIL NADU |
6369360237
bhakiyamalathi@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. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Keezhkai nelli podi |
Keezhkai nelli podi 2 grams twice daily as internal medicine. |
| Comparator Agent |
Keezhkai nelli podi along with siddhar yoga maruthuva muraigal |
Keezhkai nelli podi 2 grams twice daily with Luke warm water for 48 days along with siddhar yoga maruthuva muraigal. |
|
|
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 Polyuria Polydipsia Nocturia Polyphagia Blood glucose level FBS greater than 126 mg/dl smaller than and equivalent to 250 mg /dl PPBS greater than 200 mg/dl lesser than equivalent to 350 mg/dl HbA1C greater than 6.5 lesser than and equivalent to 8.Willing to participate in Study and signing consent by fulfilling the condition of Proforma.Patient willing to give blood and urine sample before and after the treatment |
|
| ExclusionCriteria |
| Details |
Patient with diabetic complications Diabetic foot Nephropathy Neuropathy and Retinopathy Insulin Dependent Diabetes Mellitus .Any other serious Systemic illness. Pregnancy and lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study outcome is regulate the blood sugar level |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The positive impact of yoga in the treatment
aspect may be highlighted through this study. |
48 days |
|
|
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)
|
02/06/2025 |
| 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) |
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
|
This study is an open labelled double armed non-randomized phase II clinical trial to evaluate the efficacy of KEEZHKAI NELLI PODI AND SIDDHAR YOGA MURAIGAL in the management of MADHUMEGAM (TYPE II DIABETES MELLITUS)The study contain 2 groups and divided into Group I is Keezhkai nelli podi internally and Group II is Keezhkai nelli podi internally along with siddhar yoga Muraigal. Each group contain 20 patients and duration 48 days.The study period is 24 months will be carried out in Government siddha medical College and hospital, Palayamkottai, Tirunelveli 627002, Tamilnadu.The outcome will be a positive impact of yoga therapy and medicine in the management of Madhumegam (Type II Diabetes mellitus).In case of any adverse events (AE) is noticed and it will be referred to pharmacovigilence department of Further management of patients will be given OPD patients. |