| CTRI Number |
CTRI/2018/12/016569 [Registered on: 10/12/2018] Trial Registered Prospectively |
| Last Modified On: |
06/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE EFFECT OF THE DRUG SARABENDHIRAR SIDDHA MARUTHUVA SUDAR CHOORANAM IN PATIENTS HAVING DIABETES MELLITUS-TYPE II |
|
Scientific Title of Study
|
EVALUATION OF NEERIZHIVU CHOORANAM FOR MADHUMEGAM (DIABETES MELLITUS-TYPE II)-AN OPEN CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhivyalakshmi K |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical college |
| Address |
Post graduate
Department of General Medicine
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
7094884605 |
| Fax |
|
| Email |
kjdhivya24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanakavalli K |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College |
| Address |
Department of General Medicine
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444122865 |
| Fax |
|
| Email |
drkkanakavalli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhivyalakshmi K |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical college |
| Address |
Post graduate
Department of General Medicine
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
7094884605 |
| Fax |
|
| Email |
kjdhivya24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical college
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical college |
| Address |
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106 |
| 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 Dhivyalakshmi K |
Arignar Anna Government Hospital for Indian Medicine |
Room no 2
Siddha department
Arignar Anna Hospital
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106
Chennai
TAMIL NADU |
7094884605
kjdhivya24@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: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Sarabendhirar Siddha Maruthuva Sudar chooranam |
4 Grams of Sarabendhirar Siddha Maruthuva Sudar chooranam is administrated twice a day with lukewarm water for 90 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 30 to 60 years
Newly identified Type II Diabetic cases within 6 months
Blood glucose (F)-126 mg/dl to 140 mg/dl
Blood glucose (PP)-180 mg/dl to 280 mg/dl
HBA1C-6.5% to 8%
Polyuria
Polyphagia
Polydipsia
Nocturia
|
|
| ExclusionCriteria |
| Details |
Age below 30 and above 60 years
Insulin dependent Diabetes Mellitus
Cardiovascular diseases
K/C/O Diabetic Nephropathy
K/C/O Diabetic Neuropathy
K/C/O Diabetic Retinopathy
Pregnant women and lactating mothers
T.B affected individuals will be excluded clinically or based on available medical reports |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome is mainly assessed by reduction in clinical symptoms, Blood sugar level and HbA1C level (Minimum 10 to 20%) |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/12/2018 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a single Non-randomized open clinical trial to study the safety and efficacy of Siddha trial drug SARABENDHIRAR SIDDHA MARUTHUVA SUDAR CHOORANAM. The trial drug is given 4 grams twice a day for 90 days. Clinical trial is conducted after conducting Preclinical toxicity study. The trial drug SARABENDHIRAR SIDDHA MARUTHUVA SUDAR CHOORANAM is mentioned in Sarabendhirar Siddha maruthuva sudar. During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically.
|