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CTRI Number  CTRI/2025/01/079787 [Registered on: 30/01/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Role of homoeopathic medicines in cases of diabetes mellitus type 2 
Scientific Title of Study   An experimental randomised prospective study to evaluate the role of constitutional medicines in cases of diabetes mellitus type 2  
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 Bansi virjibhai sabhaya  
Designation  Pg scholar  
Affiliation  Rajkot homoeopathic medical  
Address  Department of organon of medicine and homoeopathic philosophy,Rajkot homoeopathic medical College behind jaynath complex near makkam chowk rajkot gujarat India

Rajkot
GUJARAT
360002
India 
Phone  6351096546  
Fax    
Email  bansi.sabhaya1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka j Shroff  
Designation  Head of department of organon of medicine and homoeopathic philosophy  
Affiliation  Rajkot homoeopathic medical College  
Address  Department of organon of medicine and homoeopathic philosophy,Rajkot homoeopathic medical College behind jaynath complex near makkam chowk rajkot gujarat India.

Rajkot
GUJARAT
360002
India 
Phone  9898930311  
Fax    
Email  priyanka.shroff20492@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Priyanka j Shroff  
Designation  Head of department of organon of medicine and homoeopathic philosophy  
Affiliation  Rajkot homoeopathic medical College  
Address  Department of organon of medicine and homoeopathic philosophy,Rajkot homoeopathic medical College behind jaynath complex near makkam chowk rajkot, gujarat, India.

Rajkot
GUJARAT
360002
India 
Phone  9898930311  
Fax    
Email  priyanka.shroff20492@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Sainath homoeopathic hospital attached with rajkot homoeopathic medical College behind jaynath complex near makkam chowk rajkot gujarat India 360002 
 
Primary Sponsor  
Name  Rajkot homoeopathic medical College  
Address  Rajkot homoeopathic medical College behind jaynath complex near makkam chowk rajkot 360002 gujrat india 
Type of Sponsor  Private medical college 
 
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 Bansi virjibhai sabhaya   Rajkot homoeopathic medical College   Department of organon of medicine and homoeopathic philosophy Rajkot homoeopathic medical College behind jaynath complex near makkam chowk rajkot gujarat India
Rajkot
GUJARAT 
6351096546

bansi.sabhaya1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for human research rajkot homoeopathic medical College (RHMC)parul University gujrat   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  Individualized homoeopathic medicines   Individualized homoeopathic medicines selected by case taking 30 200 1m 10m potencies will be given to the patient according to patients succeptibilty selection of doses and repeatation of doses will be based on succeptibilty of the patient and principals of organon of medicine medicine will be administered through oral sublingual routine  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Patients of both sexes and age group between 35-65 years of both the sexes will
be considered.
2 All socio-economical classes will be considered.
3 Patients having HbA1c less than or equal to 8%.
4 Pre-diagnosed or recently diagnosed cases which are under any system of
treatment, but yet not having relief or improvement and willing to take
Homoeopathy. 
 
ExclusionCriteria 
Details  1 Patients with advance and irreversible pathological conditions or any
complications with diabetes mellitus type
2 Cases of diabetes insipidus.
3 Cases having more than 8% HbA1c.
4 Patients of less than 35 years age & more than 65 years of age of both the
sexes.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Patients of diabetes mellitus type 2 will be benefited by individual constitution homoeopathic medicines
 
This out come will be achieved 24 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
To manage the cases of diabetes mellitus type 2 with Homoeopathic medicines
• To evaluate role of homoeopathic constitutional medicines in cases of diabetes
mellitus type 2. 
The out come will be assessed 24 weeks  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2 
Date of First Enrollment (India)   10/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/02/2025 
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 Yet Recruiting 
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   DM type 2 is high prevelance chronic metabolic disorder which is increasing high
day by day in the world [13]. Diabetes occurs when pancreas does not produce enough
insulin and causes hyperglycaemia [15]. Now it is fast growing disorder in many
countries in the world and affect more numbers of people especially in poorly
developed countries [13].
By increasing its number of cases of DM type 2 it is already existing major burden for
healthcare providers.[13]
 Due to increasing its growth in next decades it may be extended double in the
population. DM type 2 is mainly a lifestyle and genetic factor disorder and that factors
are important to development of diabetes. The Number of people with DM type 2 is
increase in every country with 80% of people with DM living in low and middle
income country[13].
 The number of people with diabetes have risen from 108 million in 1980 to 422
million in 2014[15]. Out of 100 there will be 17.6% cases of diabetic retinopathy[16],
27.2% having macrovascular complications & 53.5% having microvascular
complications. Only 1% reduction in HbA1c value was associated with 37% decrease
in microvascular diseases & 14% reduction in myocardial infarction. 35078 had
microvascular complications & 21190 had no microvascular complications at
baseline.18420 had no macrovascular or microvascular complications e.g.
27.605%[17].
 According to WHO 347 million people world wide have diabetes[14]. In 2014 ,
8.5% of adult aged 18 years had diabetes. In 2019 1.5 million death and 48 % of all
deaths occurred due to diabetes before age of 70 years. 460,000 kidney disease death
were due to diabetes and 20 % of cardiovascular death occurs due to hyperglycemic
condition. From 2000 to 2019 there was 3% increase in age-standerdized mortality
rates from diabetes[15]. From every 7 individuals suffering from diabetes mellitus worldwide 1 is Indian.
In India, there is 9.6% prevalence of persons with diabetes between 20-79 years of age
group i.e. 74.2 million people in 2021.[1]
 In lower to middle income countries there are 13% increased the rate of mortality
due to diabetes[15]. Diabetes deteriorating in general quality of life affect the health
related quality of life.
 Many researches are done in the diabetes because it is the major global burden
disease condition[13]. Other mode of treatment like modern medicine is very costly but
our Homoeopathic medicines are very impactfull and cost effective.
 So here I attempt to understand the role of constitution medicine in of cases of
diabetes mellitus type 2. if our costituional medicines will be effective in mangement
of diabetes mellitus typr 2 then it will surely be helpful in some burning issues of today
like prevention of complications of diabetes mellitus type 2, improving the quality of
life of diabetes patients and bring awareness regarding risk factors and hereditary
spread of diabetes mellitus.
 
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