| CTRI Number |
CTRI/2013/06/003759 [Registered on: 17/06/2013] Trial Registered Retrospectively |
| Last Modified On: |
14/06/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Vegetable powders] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Hypoglycemic effects of bittergourd
|
|
Scientific Title of Study
|
Hypoglycemic effects of bittergourd (Momordica charantia L)among prediabetics:An intervention study in Coimbatore
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MAmirthaveni |
| Designation |
Professor |
| Affiliation |
Avinashilingam University for Women, Coimbatore-43 |
| Address |
Department of Food Science and Nutrition,
Mettupalayam road,
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9486977529 |
| Fax |
|
| Email |
amirthaveni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MAmirthaveni |
| Designation |
Professor |
| Affiliation |
Avinashilingam University for Women, Coimbatore-43 |
| Address |
Department of Food Science and Nutrition,
Mettupalayam road,
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9486977529 |
| Fax |
|
| Email |
amirthaveni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MAmirthaveni |
| Designation |
Professor |
| Affiliation |
Avinashilingam University for Women, Coimbatore-43 |
| Address |
Department of Food Science and Nutrition,
Mettupalayam road,
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9486977529 |
| Fax |
|
| Email |
amirthaveni@gmail.com |
|
|
Source of Monetary or Material Support
|
| AVRDCThe World Vegetable CenterTaiwan |
|
|
Primary Sponsor
|
| Name |
AVRDCThe World Vegetable Center |
| Address |
P.O. Box 42, Shanhua, Tainan 74199
Taiwan |
| Type of Sponsor |
Research institution |
|
|
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 |
| DrMAmirthaveni |
Avinashilingam University-Jan Shikshan Sansthan |
Deaprtment of Food science and Nutrition, Avinashilingam University for Women, Coimbator 43
Coimbatore
TAMIL NADU |
9486977529
amirthaveni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age 25
Fasting blood glucose 100 – 125 mg/dl
HbA1c between 5.7 – 6.4%
Non alcoholics
Written consent from the participants
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Evalaute the hypoglycemic effect of Momordica charantia L |
Cucumis sativus powder 2.5 g OD for 22 weeks |
| Intervention |
Evalaute the hypoglycemic effect of Momordica charantia L |
Momordica charantia L 2.5 g OD for 22 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Fasting blood glucose 100 – 125 mg/dl
HbA1c between 5.7 – 6.4%
Non alcoholics
Written consent from the participants
|
|
| ExclusionCriteria |
| Details |
Presence of complications & disorders
Taking medication
High blood pressure (>160/>100) and low blood pressure (<90/<60)
Pregnancy/ planning for pregnancy/ breast feeding
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that the consumption of bitter gourd will significantly decrease FPG compared to the placebo. Further, it is expected that the bitter gourd consumption will improve, insulin and HbA1c levels among pre-diabetic participants. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| bitter gourd is known to have anti-obesogenic effects, it is expected that there will be no weight gain during bitter gourd consumption or even some weight loss and improvement of BMI and waist-to-hip ratio (WHR). It is expected that Bitter gourd helps to prevent the onset of diabetes among the pre-diabetic participants |
22 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2013 |
| 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) |
Open to Recruitment |
|
Publication Details
|
No publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study aims to assess the anti-diabetic effects of bitter gourd drink and the study will examine the following criteria: gender, age, physical activity, dietary intake and medical history. Socio-economic and demographic information will also be assessed during the intervention study. Venous blood samples will be taken from participants four times after an overnight fast. FPG, TG, total cholesterol, HDL, and LDL concentrations will be determined by enzymatic methods. HbA1c will be determined by high-performance liquid chromatography. Hypothesis set for the study is bittergourd juice is a hypoglycemic agent. |