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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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