| CTRI Number |
CTRI/2021/10/037551 [Registered on: 25/10/2021] Trial Registered Prospectively |
| Last Modified On: |
06/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Citrullus Colocynthis on blood sugar levels |
|
Scientific Title of Study
|
To study the effect of Citrullus Colocynthis on blood sugar and Glycated hemoglobin levels in non-insulin dependent diabetes mellitus patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIl |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr RSYadav |
| Designation |
Professor |
| Affiliation |
Dr. Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Department of Biochemistry, Dr. Rajendra Prasad Government Medical College Kangra at Tanda, District Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
|
| Fax |
|
| Email |
rsy1962@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RSYadav |
| Designation |
Professor |
| Affiliation |
Dr. Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Department of Biochemistry, Dr. Rajendra Prasad Government Medical College Kangra at Tanda, District Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
|
| Fax |
|
| Email |
rsy1962@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brij Lal |
| Designation |
Junior Resident |
| Affiliation |
Dr. Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Department of Biochemistry, Dr. Rajendra Prasad Government Medical College Kangra at Tanda, District Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418703326 |
| Fax |
|
| Email |
drbrij1877@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Government Medical College Kangra at Tanda |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| 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 Brij Lal |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
Room No. 541,542.Department of Biochemistry, Dr Rajendra Prasad Government Medical College Kangra at Tanda
Kangra
HIMACHAL PRADESH |
9418703326
drbrij1877@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr Rajendra Prasad Government Medical College Kangra at Tanda |
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 |
| Intervention |
Citrullus colocynthis |
Intervention group will receive aqueous extract of Citrullus colocynthis at 1-2 ml/per day in divided doses for 8 weeks |
| Comparator Agent |
Placebo |
Control group will receive Placebo at 1-2 ml/per day in divided doses for 8 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Sampling population will comprise of adult non-insulin dependent diabetes
mellitus (NIDDM) subjects (both male and female) coming to Department of
Biochemistry, Dr. Rajendra Prasad Government Medical College and Hospital Kangra at
Tanda for clinical investigations. |
|
| ExclusionCriteria |
| Details |
i) Subject’s refusal.
ii) Being on insulin therapy.
iii) Pregnant or lactating mothers.
iv) Infectious diseases
v) Digestive tract diseases, history of surgery on digestive system.
vi) Chronic disorders of the liver, kidney and cardiovascular system.
vii) Established psychiatric disorder and on antidepressant and /or
antipsychotic therapy.
viii) History of having taken any herbal medicine for diabetes.
ix) HIV/AIDS, malignancy and substance abuse. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Citrullus colocynthis will help in reducing serum level of glycated hemoglobin and fasting blood glucose level. |
Patient recruitment
Intervention for 8 weeks with follow-up
compilation of result |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/01/2022 |
| Date of Study Completion (India) |
14/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
BENEFICIAL EFFECT OF CITRULLUS COLOCYNTHIS PLANT EXTRACT IN TYPE
2 DIABETES MELLITUS PATIENTS OF SUB-HIMALAYAN REGION.
Volume - 12 | Issue - 07 | July - 2023 | PRINT ISSN No. 2277 - 8179 | DOI : 10.36106/ijsr |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Clinical studies have also shown that Citrullus colocynthis fruit has a considerable effect on reduction in the mean serum level of glycated hemoglobin (HbA1c) and fasting blood sugar (FBS) in patients with the T2DM . However, the role of the Citrullus colocynthis in diabetic patients in India scenario has not yet been fully explored. Hence, the present study aims to evaluate the role of Citrullus colocynthis in NIDDM patients coming to Dr Rajendra Prasad Government Medical College Kangra at Tanda, Himachal Pradesh, India. |