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CTRI Number  CTRI/2025/02/080905 [Registered on: 19/02/2025] Trial Registered Prospectively
Last Modified On: 17/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A clinical trial to study the effect of Homoeopathic preparation of Gymnema sylvestre mother tincture, 6C and 30C in patients of Diabetes mellitus type 2 
Scientific Title of Study   Phytochemical screening of Gymnema sylvestre mother tincture and validation of the hypoglycemic effect of Gymnema sylvestre mother tincture, 6C and 30C in patients of Diabetes mellitus type 2 with HbA1c parameter: An open label randomized controlled clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Irfan Munir 
Designation  Post graduate trainee 
Affiliation  National Institute of Homoeopathy 
Address  National Institute of Homoeopathy, Department of Homoeopathic pharmacy, Block- GE, Sector III, Salt lake, Kolkata

North Twentyfour Parganas
WEST BENGAL
700106
India 
Phone  8787262443  
Fax    
Email  drirfanmunir12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gitasri Pal 
Designation  Professor (SAG) 
Affiliation  National Institute of Homoeopathy 
Address  National Institute of Homoeopathy, Department of Homoeopathic Pharmacy, Block- GE, Sector III, Salt lake, Kolkata

North Twentyfour Parganas
WEST BENGAL
700106
India 
Phone  9163955737  
Fax    
Email  Drrajanih@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gitasri Pal 
Designation  Professor (SAG) 
Affiliation  National Institute of Homoeopathy 
Address  National Institute of Homoeopathy, Department of Homoeopathic Pharmacy, Block- GE, Sector III, Salt lake, Kolkata

North Twentyfour Parganas
WEST BENGAL
700106
India 
Phone  9163955737  
Fax    
Email  Drrajanih@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy, Block - GE, Sector- III, Salt lake, Kolkata, North Twentyfour Parganas- 700106, West Bengal , India 
 
Primary Sponsor  
Name  National Institute of Homoeopathy 
Address  National Institute of Homoeopathy, Block - GE, Sector- III, Salt lake, Kolkata, North Twentyfour Parganas- 700106, West Bengal , India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NI 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Irfan Munir  National Institute of Homoeopathy  National Institute of Homoeopathy, Department of Homoeopathic pharmacy, OPD Number 19, Block - GE, Sector- III, Salt lake, Kolkata, North Twentyfour Parganas- 700106, West Bengal , India
North Twentyfour Parganas
WEST BENGAL 		 8787262443

drirfanmunir12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NATIONAL INSTITUTE OF HOMOEOPATHY  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 
Comparator Agent  Gymnema sylvestre mother tincture in first arm, Gymnema sylvestre 6C in second arm and Gymnema sylvestre 30 C in third arm  Each doses of Gymnema sylvestre mother tincture in first arm consisting of 10 drop in half cup distilled water and prescribed TDS per day for one month. Each dose of Gymnema sylvestre 6C in second arm consisting of 4 globules in globules no: 20 and prescribed OD per day for one month. Each dose of Gymnema sylvestre 30 C in third arm consisting of 4 globules in globules no: 20 and prescribed OD every third day for one month. Remaining day’s placebo is to be given in all arm.  
Intervention  Gymnema sylvestre mother tincture, Gymnema sylvestre 6C and Gymnema sylvestre 30 C  Gymnema sylvestre mother tincture 10 drop in half cup of distilled water three times in a day orally for one month. Gymnema sylvestre 6C 4 globules once in a day orally for one month. Gymnema sylvestre 30C 4 globules once a day in every third day orally for one month. Remaining day’s placebo is to be given in all arm. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of different religions and socioeconomic groups. Patients who are untreated before and have opted for homoeopathic treatment.
Patient who have already had other medication but now intend to undergo homoeopathic treatment.
Confirmed cases of diabetes mellitus type 2 patients.
Patients with Glycosylated haemoglobin (HbA1c) is equal to or greater than 6.5 %, Post prandial blood sugar (PPBS) is equal to or greater than 11.1 mmol/l (200 mg/dl) and Fasting blood sugar (FBS) is equal to or greater than 7.0 mmol/l (126 mg/dl) in type 2 diabetes mellitus.
Patient willing to undergo laboratory investigations whenever required.
Patient willing to give written consent for participating in the study and complete follow-up during study. 
 
ExclusionCriteria 
Details  Patient taking medicines for diabetes mellitus type 2 complications.
Patients suffering from any life threatening illness or any major complication of diabetes
mellitus type 2 and other associated co-morbities.
Patients not willing to undergo any investigations, even after advised. Pregnancy.
Patients whose blood glucose level were not controlled within 3 months after giving
Homoeopathic medicine Gymnema sylvestre mother tincture or Gymnema sylvestre 6C or Gymnema sylvestre 30C.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Glycosylated hemoglobin (HbA1c)  at baseline, 3
months and 6 months.
 
 
Secondary Outcome  
Outcome  TimePoints 
Post prandial blood sugar (PPBS) & Fasting blood sugar (FBS).   at baseline, 3 months & 6 months. 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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 
Date of First Enrollment (India)   11/03/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   samples will be selected following preliminary and detailed screening using specified selection criteria. Inclusion and exclusion criteria are strictly followed, eligible patients will be recruited for the trial . General (Non-medicinal) management including appropriate diet and regimen will be advised. subsequent prescriptions (follow-ups) will be generated according to relevant homoeopathic principles and will be recorded in follow-up sheets. baseline data will be compared with the data obtained in 3 months or 6 months. Each case will be studied properly through analysis and evaluation of symptoms and the symptoms will be matched against the symptoms of Gymnema sylvestre. Response of the patients will be observed and improvement in clinical symptoms with checking of Glycosylated hemoglobin (HbA1c), post prandial blood sugar (PPBS) and fasting blood sugar (FBS) level in type 2 diabetes mellitus at Baseline, 3 month and 6 months of treatment. 
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