| CTRI Number |
CTRI/2024/06/068929 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Nutritional Supplement Momordica Charantia in Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Effectiveness And Safety of Nutritional Supplement Momordica Charantia in Type 2 Diabetes Mellitus:Randomised Open Label Study- PG Dissertation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kancherla Narasimha Abhinav Kaushal |
| Designation |
Post graduate, Pharmacology |
| Affiliation |
Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Pharmacology, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar
Kolar KARNATAKA 563101 India |
| Phone |
7760491183 |
| Fax |
|
| Email |
kaushal.abhinav01@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sarala N |
| Designation |
Professor and Head |
| Affiliation |
R L Jalappa Hospital & Research Center, Sri Devaraj Urs Medical College |
| Address |
Professor And Head, Department Of Pharmacology, Sri Devaraj Urs Medical College, Tamaka, Kolar
Kolar KARNATAKA 563101 India |
| Phone |
9845750165 |
| Fax |
|
| Email |
saralan@sduaher.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Sarala N |
| Designation |
Professor and Head |
| Affiliation |
R L Jalappa Hospital & Research Center, Sri Devaraj Urs Medical College |
| Address |
Professor And Head, Department Of Pharmacology, Sri Devaraj Urs Medical College, Tamaka, Kolar
Kolar KARNATAKA 563101 India |
| Phone |
9845750165 |
| Fax |
|
| Email |
saralan@sduaher.ac.in |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar, Karnataka, India. Pin code- 563103 |
|
|
Primary Sponsor
|
| Name |
Kancherla Narasimha Abhinav Kaushal |
| Address |
Postgraduate, Department of Pharmacology, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar, Karnataka, India. Pin Code- 563103 |
| Type of Sponsor |
Other [Self] |
|
|
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 Kancherla Narasimha Abhinav Kaushal |
R L Jalappa Hospital and Research Center, Sri Devaraj Urs Medical College |
Out Patient Department, General Medicine, Ground Floor Kolar KARNATAKA |
7760491183
kaushal.abhinav01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee, Sri Devaraj Urs Academy of Higher Education and Research |
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 |
Metformin 500-1500mg/day +
Sulfonylureas (Glimepiride 2-6 mg/day) +
Tablet.Karavellaka(Momordica Charantia) 250mg |
Participants in the group A will be receiving Metformin 500-1500mg/day + Sulfonylureas (Glimepiride 2-6 mg/day) + Momordica Charantia (Karavellaka) 250mg twice daily for 12 Weeks |
| Comparator Agent |
Metformin 500-1500mg/day + Sulfonylureas (Glimepiride 2-6 mg/day) |
Participants in the group B will receive only Metformin 500-1500mg/day + Sulfonylureas (Glimepiride 2-6 mg/day) for 12 Weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with type 2 diabetes mellitus
Patients receiving two drugs (Sulfonylureas (Glimepiride) + Metformin) for a minimum period of 12 weeks
Patients with HbA1c 6.5 To 8%
|
|
| ExclusionCriteria |
| Details |
Patients with type 2 diabetes mellitus receiving insulin
Patients with liver dysfunction
Patients who are on treatment with either steroids or immunosuppressive agents
Pregnancy or Lactation
Patients with renal impairment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Assess the Effect of Momordica Charantia (Mc) Supplement on Blood Sugar and HbA1c In Type 2 Diabetic Patients Receiving Oral Antidiabetic Medications
To assess adverse effects of Momordica charantia supplement using WHO causality assessment scale |
Blood sugar,HbA1c and adverse effects at 0(baseline),Week 6,Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="92" Sample Size from India="92"
Final Enrollment numbers achieved (Total)= "92"
Final Enrollment numbers achieved (India)="92" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/06/2024 |
| Date of Study Completion (India) |
30/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Type 2 diabetes mellitus (type2 dm) is one of the major
health problems and it is an important cause of morbidity and mortality. Diabetes
mellitus is a growing global public health problem, and it is characterized by
hyperglycemia. The developing and underdeveloped countries have recently
witnessed an increase in the prevalence of diabetes mellitus. Uncontrolled diabetes can lead to increased
risk of macrovascular (cardiovascular, cerebrovascular, and peripheral artery
disease) and microvascular (diabetic retinopathy, nephropathy, and neuropathy) complications.
Intervention in the form of diet and exercise can delay the onset of diabetes
and complications. The initial treatment includes the use of oral antidiabetic
medications and insulin can be considered in these patients when blood sugar is
inadequately controlled. Momordica charantia
(mc), known as bitter melon, has been reported to have antiviral,
antibacterial, anti-cancer, and immune-modulating properties. The active
components of mc are charantin, vicine, and polypeptide p which are
structurally similar to animal insulin. The probable mechanisms of action
include increased insulin-like effects, stimulation of pancreatic secretion
leading to decreased hepatic gluconeogenesis, increased hepatic glycogen
synthesis, and increased peripheral glucose oxidation. Momordica charantia has
been widely used as a complementary or alternative therapy for treating
diabetes mellitus in many other countries. There are few studies regarding the
effect of Momordica charantia as an adjuvant for type 2 diabetes mellitus
especially in India. This study will give us the efficacy and safety of
Momordica charantia on blood sugar levels in type 2 diabetes mellitus patients
who are on oral anti-diabetic medications. |