| CTRI Number |
CTRI/2016/10/007396 [Registered on: 21/10/2016] Trial Registered Prospectively |
| Last Modified On: |
21/10/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Test the effect of Tab. Thiriphala Chooranam in pre diabetic population |
|
Scientific Title of Study
|
Open Labeled Randomized Controlled Clinical Trial on Impaired Glucose Tolerance – IGT (MUNNEERIZHUVU) |
| Trial Acronym |
OLRCCTIGT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Kannan |
| Designation |
Research Officer |
| Affiliation |
Siddha Central Research Institute |
| Address |
Siddha Central Research Institute
Central council for Research in Siddha
Ministry of AYUSH Govt of India
Arumbakkam Chennai
Siddha Central Research Institute
Central council for Research in Siddha
Ministry of AYUSH Govt of India
Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
04426214809 |
| Fax |
04426214809 |
| Email |
siddhikanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Kannan |
| Designation |
Research Officer |
| Affiliation |
Siddha Central Research Institute |
| Address |
Siddha Central Research Institute
Central council for Research in Siddha
Ministry of AYUSH Govt of India
Arumbakkam Chennai
Siddha Central Research Institute
Central council for Research in Siddha
Ministry of AYUSH Govt of India
Arumbakkam Chennai
TAMIL NADU
600106
India |
| Phone |
04426214809 |
| Fax |
04426214809 |
| Email |
siddhikanna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Kannan |
| Designation |
Research Officer |
| Affiliation |
Siddha Central Research Institute |
| Address |
Siddha Central Research Institute
Central council for Research in Siddha
Ministry of AYUSH Govt of India
Arumbakkam Chennai
Siddha Central Research Institute
Central council for Research in Siddha
Ministry of AYUSH Govt of India
Arumbakkam Chennai
TAMIL NADU
600106
India |
| Phone |
04426214809 |
| Fax |
04426214809 |
| Email |
siddhikanna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central council for Research in Siddha
Ministry of AYUSH Govt of India
Anna Hospital campus
Arumbakkam
Chennai - 600 106
Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Dr M Kannan |
| Address |
Siddha Central Research Institute
Central council for Research in Siddha
Ministry of AYUSH Govt of India
Arumbakkam Chennai |
| Type of Sponsor |
Other [Individual - Ph. D. Study] |
|
|
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 Kannan |
Siddha Central Research Institute |
Room 2, OPD Divison, Dept. of Clinical Research, Siddha Central Research Institute
Central council for Research in Siddha
Ministry of AYUSH Govt of India
Arumbakkam Chennai 600106
Chennai
TAMIL NADU |
9841207207
siddhikanna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Siddha Central Research Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Impaired Glucose Tolerance (Munnerizhivu), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Life Style Modification (LSM) |
Balanced Diet along with brisk walking not less than 150 min/week |
| Intervention |
Tab. Thiriphala Chooranam |
500mg 4 tab BD 6 Month |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Males or Females with a diagnosis of Impaired Glucose Tolerance (Munnerizhivu).
IGT defined as those patients with Fasting glucose levels -- above 100 mg/dl to within or equal to 125 mg/dl
After 2 hour OGTT -- within 140 mg/dl to 199 mg/dl
Glycated hemoglobin (HbA1C)-- Above 6.0% to within 6.5% |
|
| ExclusionCriteria |
| Details |
Subjects with the age below 30 and above 60 years
known Diabetes, Malignant and accelerated hypertensive, Chronic Liver and Renal diseases, Coronary artery disease, Secondary Diabetes mellitus, CNS disorder (e.g. encephalopathy)
Patient undergoing regular treatment for any other severe illness
Pregnant woman and planning to be pregnant within six months and lactating mother |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| During treatment or after treatment OGTT 2 hours result is less than 140 mg/dl, fasting blood sugar is lessthan 100 mg/dl and HbA1c is lessthan or equal to 6.0 % it will be treated as successful outcome of the treatment. |
180 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Normal Liver function test and renal function test should be taken as success end point towards safety. |
180 Days |
|
|
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)
|
01/11/2016 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Open Labeled Randomized Controlled Clinical Trial to assess the efficacy of Tablet Thiriphala chooranam 500mg, 4 for twice a day for 180 days in 60 patients with Impaired Glucose Tolerance- IGT(Munnerizhivu). It is Open labeled and Double arm study. The primary outcome is during treatment or after treatment OGTT 2 hours result is less than 140 mg/dl, fasting blood sugar is lessthan 100 mg/dl and HbA1c is lessthan or equal to 6.0 % it will be treated as successful outcome of the treatment. The time limit is 180 days. |