| CTRI Number |
CTRI/2019/08/020946 [Registered on: 28/08/2019] Trial Registered Prospectively |
| Last Modified On: |
27/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Clinical trial of Siddha Drug "Naga Chendhooram" for Diabetes |
|
Scientific Title of Study
|
Phase II non-randomized open clinical evaluation of Siddha Drug "Naga Chendhooram" for Madhumegam (Type 2 Diabetes Mellitus)- in patients of both gender between age group of 30 to 60 years, attending OPD at AAGHIM attached with GSMC |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jani Antony S |
| 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
Post Graduate Department of General Medicine Government Siddha Medical College
6 Anna Arch Road NSK Nagar Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9994880753 |
| Fax |
|
| Email |
janiantony27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sasi Rekha R |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College
6 Anna Arch Road NSK Nagar Arumbakkam Chennai
Post Graduate Department of General Medicine Government Siddha Medical College
6 Anna Arch Road NSK Nagar Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9444832728 |
| Fax |
|
| Email |
sasirekha.siddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jani Antony S |
| 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
Post Graduate Department of General Medicine Government Siddha Medical College
6 Anna Arch Road NSK Nagar Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9994880753 |
| Fax |
|
| Email |
janiantony27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College 6 Anna Arch Road NSK Nagar Arumbakkam Chennai 600106 Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College 6 Anna Arch Road NSK Nagar Arumbakkam Chennai 600106 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 Jani Antony S |
Arignar Anna Government Hospital of Indian Medicine |
Room No 2
Department of Siddha
Arignar Anna Government Hospital of Indian Medicine
6 Anna Arch Road NSK Nagar Arumbakkam Chennai 600106
Chennai
TAMIL NADU |
9994880753
janiantony27@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: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Naga Chendhooram |
100 mg twice a day with milk for 90 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Mandatory
Fasting blood glucose-120 to 160 mg/do
PP blood glucose- 180 to 280 mg/DL
HbA1c- 6.5 to 9%
Optional
Polyuria
Polyphagia
Polydipsia
Nocturia
|
|
| ExclusionCriteria |
| Details |
Insulin dependent Diabetes mellitus
Cardiovascular disease
Diabetic nephropathy
Diabetic retinopathy
Pregnant women
Lactating mothers
Tuberculosis affected individuals
HbA1c > 9% |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in clinical symptoms
Reduction in blood sugar and HbA1c level by atleast 20% or to maintain HbA1c level within 7% |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is assessed by comparing the safety parameters before and after treatment |
90 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
04/09/2019 |
| 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 Non randomised open clinical trial to study the safety and efficacy of siddha drug "Naga Chendhooram". Drug is given 100 mg twice a day for 90 days. Clinical trial is conducted after completion of preclinical toxicity studies. The said drug "Naga Chendhooram" has reference in "Siddha Formulary of india" - part1 . During the study, all the related data will be recorded and documented. |