| CTRI Number |
CTRI/2023/05/052423 [Registered on: 09/05/2023] Trial Registered Prospectively |
| Last Modified On: |
05/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trail on thottar chinungi chooranam in the management of Madhumegam(Diabetes Melitus) |
|
Scientific Title of Study
|
A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON-
RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO
DETERMINE THE EFFECTIVENESS OF THOTTAR CHINUNGI CHOORANAM
IN THE MANAGEMENT OF MADHUMEGA NOI (DIABETES MELLITUS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K SUGANTHI |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8610373243 |
| Fax |
|
| Email |
suganthikesavan1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTKomalavalli MDsPhD |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam, OP no 10,Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr A Manoharan MDsPhD |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam, OPno 10,Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Central Library of Government Siddha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli,Tamilnadu |
| 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 K Suganthi |
Government Siddha Medical College and Hospital |
PG Department of Pothu Maruthuvam, OP no 10,Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002, Tamilnadu.
Tirunelveli
TAMIL NADU |
8610373243
suganthikesavan1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
THOTTAR CHINUNGI CHOORANAM |
Dosage:1to 2 gram
Adjuvant: Hot water
Frequency:twice a day
Duration: 45 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with symptoms of polyuria, polydipsia, polyphagia,asthenia, nocturia, obesity(metabolic syndrome),numbness,tingling sensation,mood changes and irritability difficulty in concentration.
2.Even if patients is having any one among the three (WHO criteria 2019)
a. FBS>126mg/dl and <250 mg/dl or
b. PBS>200 mg/dl and <350 mg/dl or
c. HbA1c>6.5 and <10 |
|
| ExclusionCriteria |
| Details |
1.Age below 34 years and above 60 years
2.Type I diabetes mellitus
3.Gestational diabetes
4.Diabetes insipidus
5.Pregnancy
6.Lactating mother
7.Chronic kidney disease
7.Ischemic 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 126 mg dl & PPBS below 200 mg dl and HbA1c below 6.5 |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of the sign and symptoms of polyuria, polydipsia, polyphagia, asthenia, nocturia, numbness, tingling sensation, nausea, mood changes and irritability, difficulty in concentration |
90days |
|
|
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)
|
21/05/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
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 THOTTAR CHINUNGI CHOORANAM in the management of MADHUMEGA NOI(DIABETES MELLITUS). The trial drug will be administered at the dose of 1-2 gram twice a day 90 days in 40 patients. The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli 627002 , Tamil nadu. The primary outcome will be the evaluation of therapeutic efficacy of the trial drug THOTTAR CHINUNGI CHOORANAM. The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of safety profile of trial drug, assessment of pharmacological and biochemical parameters of the trial drug. In case of any adverse events(AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients Will be given in OPD facility. |