| CTRI Number |
CTRI/2026/03/105889 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on Veppampisin chooranam in the management of Madhumegam (Type II Diabetes Mellitus) |
|
Scientific Title of Study
|
A PROSPECTIVE, OPEN LABELLED, SINGLE ARM, NON-RANDOMIZED, SINGLE CENTRIC, PHASE II, CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF VEPPAMPISIN CHOORANAM 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 M SOUNDHARYA |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai. |
| Address |
Op number 10, PG Department of Pothu Maruthuvam Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8754245617 |
| Fax |
|
| Email |
soundharyapapu250@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR P SATHISH KUMAR |
| Designation |
Associate Professor |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai. |
| Address |
Op number10,PG Department of Pothu Maruthuvam Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9944337757 |
| Fax |
|
| Email |
drpsk_md@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR S JUSTUS ANTONY |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai. |
| Address |
Op number 10, PG Department of Pothu Maruthuvam Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and central library of Government Siddha Medical College and Hospial,Palayamkottai,Tirunelveli-627002,India. |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002 |
| 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 |
| DR M SOUNDHARYA |
Government Siddha Medical College and Hospital |
Op number 10,PG Department of Pothu Maruthuvam,Government Siddha Medical College and
Hospital,Thiruvananthapuram Road, Palayamkottai-627002
Tirunelveli
TAMIL NADU |
8754245617
soundharyapapu250@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Siddha Medical College,palayamkottai,Tirunelveli-627002 |
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 |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Veppampisin chooranam |
Dosage:1 gram, Twice a day for 90days
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
If patient is having anyone among the three(WHO Criteria 2019)
FBS-Above 126mg/dl and below 250mg/dl or
PPBS-Above 200mg/dl and below 350mg/dl or
HbA1c-6.5% to 10%
Patients with symptoms of polyuria, polydipsia, polyphagia and nocturia |
|
| ExclusionCriteria |
| Details |
Type 1 Diabetes Mellitus
Gestational DM
Diabetes Insipidus
Pregnancy
Lactating mother
Chronic kidney disease
Chronic liver disease
Ischaemic heart disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| If during treatment or after treatment FBS became below 126mg/dl & PPBS below 200mg/dl and HbA1c below 6.5% |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of the sign and symptoms of polyuria, polydipsia, polyphagia and nocturia |
6 months |
|
|
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)
|
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="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
|
This study is a prospective open labelled, single arm, non-randomized, single centric, phase II clinical trial to determine the effectiveness of VEPPAMPISIN CHOORANAM in the management of MADHUMEGAM (TYPE II DIABETES MELLITUS). The trial drug will be administered at the dose of 1 gram twice a day for 90 days in 40 patients. The primary outcome will be the evaluation of therapeutic efficacy of the trial drug VEPPAMPISIN CHOORANAM.The secondary outcome will be the evaluation of siddha diagnostic parameters, assessment of biochemical and phytochemical parameters of the trial drug will be performed |