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CTRI Number  CTRI/2024/06/069393 [Registered on: 24/06/2024] Trial Registered Prospectively
Last Modified On: 21/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic management of Type II Diabetes mellitus 
Scientific Title of Study   A clinical approach to understand the miasmatic background of type II diabetes mellitus and its homoeopathic management 
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 DIVYA V 
Designation  PG SCHOLAR 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  IIIrd Floor,College Building, Department Of Organon Of Medicine, Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari District, Tamil nadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  7397362810  
Fax    
Email  divyadevan010@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr MANOJ NARAYAN V 
Designation  PROFESSOR 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  IIIrd Floor,College Building, Department Of Organon Of Medicine, Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari District, Tamil nadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9995114518  
Fax    
Email  manojnarayanv@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr MANOJ NARAYAN V 
Designation  PROFESSOR 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  IIIrd Floor,College Building, Department Of Organon Of Medicine, Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari District, Tamilnadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9995114518  
Fax    
Email  manojnarayanv@gmail.com  
 
Source of Monetary or Material Support  
Institution- Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari District, Tamil nadu, India ,629161  
 
Primary Sponsor  
Name  Post Graduate Research Funded By College 
Address  Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari District,Tamilnadu 629161 
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 DIVYA V  Sarada Krishna Homoeopathic Medical College  Opd,Ipd,Rural Health Centres Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari,Tamil Nadu,629161 Kanniyakumari TAMIL NADU
Kanniyakumari
TAMIL NADU 		 7397362810

divyadevan010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sarada Krishna Homoeopathic Medical College  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  Homoeopathic Medicine  Case taking, selection and administration of medicine will be based on Homoeopathic principles. The case is analysed and repertorization will be made using RADAR 10 Homoeopathic software. The repertorial result will be analyzed by noting down the remedies and their scoring of symptoms. Then the Miasmatic analysis will be made by categorizing the analyzed and evaluated symptoms with the help of “R.P Patel’s Chronic Miasm in Homoeopathy and their cure with the classification of their rubrics/symptoms in Dr. Kent’s Repertory” (Repertory of Miasm). The remedy selected based on miasm will be given, the potency and dosage will be selected according to the susceptibility of the patient at the time of prescription. The follow up will be made once in fifteen or thirty days for all the cases. The 30th, 60th and 90th day – FBS and PPBS level will be noted to assess the improvement. During the 1st visit and 90th day of follow-up, HbA1c level will be noted for standardized assessment. The improvement in the Quality of life of the patient is measured using Diabetic Quality of Life Questionnaire. Each patient will be assessed for a period of 3months.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients pre diagnosed with type 2 Diabetes Mellitus.
Patients between the age group 30 to 60 years.
Both sexes.
Patients with fasting plasma glucose greater than or equal to 126 mg per dl.
Patient with HbA1c greater than 6.5
Patient with post prandial blood glucose level greater than or equal to 200mg per dl. 
 
ExclusionCriteria 
Details  Pregnant and Lactating women.
Patients below 30 and above 60 years.
Patients suffering from serious systemic illness like Myocardial Infarction, cerebro vascular accident.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Usefulness of understanding the miasmatic background of type II Diabetes Mellitus in its Homoeopathic management.  3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
The 30th, 60th and 90th day, FBS and PPBS level will be noted to assess the improvement.  3 Months 
HbA1c level will be noted from baseline and 90th day of followup  3 Months 
The improvement in the Quality of life of the patient measured using Diabetic Quality of Life Questionnaire  3 Months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 4 
Date of First Enrollment (India)   02/07/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Diabetes mellitus is a clinical syndrome characterized by an increase in plasma blood glucose level. The estimates in 2019 showed that 77 million individuals had diabetes in India, which is expected to rise to over 134 million by 2045. India, crowned as ‘diabetes capital’ of the world. The median direct cost of diabetes is estimated to be ₹18,890/- per annum. This study is an attempt to reduce burden of type 2 diabetes mellitus in near future. Dr. Samuel Hahnemann, before 200 years gave a wonderful theory of miasm. In 1828, this theory was first given by him in his work, “The Chronic Diseases, Their Peculiar Nature and Their Homoeopathic Cure”. He considered miasm as the root cause for all the diseases. In the footnote of aphorism 41, Hahnemann clearly states that “no real amalgamation of two takes place,” which means that there is no mixed miasmatic state. Based on this, if the symptoms of type 2 diabetes mellitus patient, analyzed based on miasm, the dominant miasm and the miasmatic nature of Diabetes Mellitus can be found. Then the miasmatic prescription is made and the condition can be managed and the complications can be prevented. This can also reduce the tendency for the recurrence of the complaints, dyscracia or diathesis.

 
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