| CTRI Number |
CTRI/2018/03/012505 [Registered on: 12/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
09/03/2018 |
| 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 to study the effect of the drug Perungaya Chooranam in patients having Diabetes Mellitus (Madhumegam) |
|
Scientific Title of Study
|
An open Non-randomized clinical trial of Perungaya Chooranam in Madhumegam(Diabetes Mellitus- Type II ) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nithya 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
Post Graduate Department of General Medicine
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9176808837 |
| Fax |
|
| Email |
nithyb4u@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anbu N |
| Designation |
HOD and Professor |
| 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
Post Graduate Department of General Medicine
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nithya 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
Post Graduate Department of General Medicine
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nithyb4u@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 Nithya K |
Aringar Anna Government Hospital of Indian Medicine |
Room No 2
Siddha Department
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
600106
Chennai
TAMIL NADU |
9176808837
nithyb4u@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 |
MALE AND FEMALE WITH POLYURIA,POLYDYPSIA,BURNING SENSATION AND NUMBNESS OVER THE FOOT AND PALM, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
PERUNGAYA CHOORANAM
|
2 grams of Perungaya chooranam is administrated twice a day with luke warm water for 90 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Newly identified type II cases only
Subject within 30-60 years
Blood glucose(F)- 120-140mg/dl
Blood glucose(PP)-180-280mg/dl
Blood glucose(R)-200-300mg/dl
HbA1C - 6.5 TO 8%
Polyuria
Polyphagia
Polydypsia
Nocturia
Fatigue |
|
| ExclusionCriteria |
| Details |
H/O Insulin Dependent Diabetes Mellitus
H/O Cardiovascular Disease
H/O Diabetic Nephropathy
H/O Diabetic Retinopathy
Pregnant Women, Lactating mothers,T.B affected individuals |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is mainly assessed by reduced blood sugar and HbA1C Level and reduced in clinical symptoms |
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="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)
|
05/01/2018 |
| 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) |
Open to Recruitment |
|
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 randomised open clinical trial to study the safety and efficacy of Siddha trial drug Perungaya chooranam. The trial drug is given 2grams twice a day for 90 days. Clinical trial is conducted after conducting Pre clinical toxicity study. The trial drug Perungaya chooranam is mentioned in Sarabenthira vaithiya rathnavali. 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. |