| CTRI Number |
CTRI/2026/03/105397 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Siddha Medicine Aavarai Vithaadhi Chooranam in the Management of Type 2 Diabetes (Madhumegam) |
|
Scientific Title of Study
|
Single centric Phase II open clinical trial in Madhumegam (type II diabetes mellitus) with the Siddha medicine Aavarai Vithaadhi Chooranam |
| 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.V.V.NIRRAIMATHI |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Siddha Medical College, Chennai |
| Address |
Room No S1,PG Department of Pothu Maruthuvam, Government Siddha Medical College Arumbakkam,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8489475570 |
| Fax |
|
| Email |
vvnirraimathi27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U CHITRA |
| Designation |
LECTURER |
| Affiliation |
Government Siddha Medical College, Chennai |
| Address |
Room No S1, PG Department of Pothu Maruthuvam,Government Siddha Medical College , Arumbakkam ,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9445716802 |
| Fax |
|
| Email |
mmsankar2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr U CHITRA |
| Designation |
LECTURER |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE, CHENNAI |
| Address |
Room No S1, PG Department of Pothu Maruthuvam,Government Siddha Medical College , Arumbakkam ,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9445716802 |
| Fax |
|
| Email |
mmsankar2000@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr VV Nirraimathi |
| Address |
Room No S1, PG Department of Pothu Maruthuvam, Government Siddha Medical College, Chennai 600106 |
| 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 VV Nirraimathi |
GOVERNMENT SIDDHA MEDICAL COLLEGE, ARUMBAKKAM, CHENNAI |
Room No S1, PG Department of Pothu Maruthuvam, Government Siddha Medical College , Arumbakkam ,Chennai - 600106
Chennai
TAMIL NADU |
8489475570
vvnirraimathi27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aavarai Vithaadhi Chooranam |
100 gms of Cassia auriculata seeds and required quantity of juices of Ficus racemosa, Terminalia arjuna, Phyllanthus emblica, Asparagus racemosus, Musa paradisiaca, Tribulus terrestris, Tinospora cordifolia, Michelia champaca, Aloe barbadensis taken. Purified Aavarai seeds are soaked in above mentioned nine different types of juices for nine consecutive days, with each day using one type of juice. After soaking, the seeds are dried, powdered, sieved through a fine cloth, and stored separately in a clean, dry, airtight container .
DOSAGE : 3 grams
TIME OF ADMINISTRATION : Twice a day (After food)
ADJUVANT : Hot Water
DURATION : 90 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
HbA1c : 6-10 percent
UKPDS Risk Score Within 10-25 percent |
|
| ExclusionCriteria |
| Details |
K/H/O Hypertension
Smoker
Insulin Dependent Diabetes Mellitus
Vulnerable Population |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome is mainly assessed by :
Reduction of HbA1C level after taking a medication by
1. 20 percentage - Good
2. 10 percentage - Fair
3. less than 10 percentage - Poor |
HbA1c will be assessed at baseline (Day 0) and after 90 days of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in UKPDS score by 5 percentage of risk . |
90 days |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
25/03/2026 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vvnirraimathi27@gmail.com].
- For how long will this data be available start date provided 27-03-2026 and end date provided 11-08-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is Single Centric Phase 2 open clinical trial in Madhumegam (type 2 diabetes mellitus) with siddha medicine Aavarai Vithaadhi Chooranam. The Dosage of Aavarai Vithaadhi Chooranam is 3 gram with hotwater ( twice a day) for 90 days The sample size for the study is 44 The outcome is mainly assessed by Reduction of HbA1c level by 20 percentage - good, 10 percentage - fair, less than 10 percentage- poor Reduction of UKPDS cardiovascular risk ratio by 5 percentage |