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CTRI Number  CTRI/2024/03/063791 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 05/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effectiveness of homoeopathic medicines along with conventional medicines in the management of Type-2 Diabetes Mellitus. 
Scientific Title of Study   Effectiveness of the Individualized Homoeopathic Medicines in LM potencies as an adjuvant to conventional medicines in the management of Type-2 Diabetes Mellitus: A single-blind 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 Pawan Sharma 
Designation  Post Graduate Scholar, Department of Practice of Medicine 
Affiliation  National Homoeopathy Research Institute in Mental Health 
Address  Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, Kurichy, Sachivothamapuram

Kottayam
KERALA
686532
India 
Phone  9927722220  
Fax    
Email  pspawansharma40@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinitha E R 
Designation  Associate Professor, Department of Practice of Medicine 
Affiliation  National Homoeopathy Research Institute in Mental Health 
Address  Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, Kurichy, Sachivothamapuram

Kottayam
KERALA
686532
India 
Phone  9567847444  
Fax    
Email  vinitha_sajeev@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Vinitha E R 
Designation  Associate Professor, Department of Practice of Medicine 
Affiliation  National Homoeopathy Research Institute in Mental Health 
Address  Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, Kurichy, Sachivothamapuram

Kottayam
KERALA
686532
India 
Phone  9567847444  
Fax    
Email  vinitha_sajeev@yahoo.co.in  
 
Source of Monetary or Material Support  
National Homoeopathy Research Institute in Mental Health,Kurichy,P.O. Sachivothamapuram, Kottayam, Kerala-686532 
 
Primary Sponsor  
Name  Dr. Pawan Sharma 
Address  National Homoeopathy Research Institute in Mental Health, Kurichy, P.O Sachivothamapuram, Kottayam, Kerala-686532 
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 Pawan Sharma  National Homoeopathy Research Institute in Mental Health  Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, Kurichy, Sachivothamapuram
Kottayam
KERALA 		 9927722220

pspawansharma40@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee,National Homoeopathy Research Institute in Mental Health  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicines in LM potencies  LM potency will be started from the 0/1 or the least available potency, followed by the next higher potency, serially, as per need of the case. The pharmacist on instruction from the investigator will dispense the medicine/placebo as follows: One globule (poppy seed size) of the desired potency will be dissolved in 120 ml of distilled water, containing 2.4 ml (2% v/v) of dispensing alcohol, premixed in it, followed by 10 uniformly forceful downward strokes will be given against the bottom of the phial. The medicine would be repeated as per the instructions given in the literature. Each participant will be advised to give 10 uniformly forceful downward strokes to the bottle with the hand on a hard surface and to take three teaspoonfuls (15 ml) of this solution and mix it in eight teaspoonfuls26 (40 ml) of water in a clean glass after stirring the solution for each dose of medicine would be taken. One teaspoonful (5 ml) of this solution will constitute one dose29. If no change at all the case shall be retaken and another appropriate Individualized Homoeopathic remedy in LM potency will be prescribed. If any acute complaint arises current acute totality will be taken and the remedy which is most suitable will be provided. 
Comparator Agent  Placebo  Placebo (One globule [poppy seed size] dissolved in 120 ml of distilled water; in the same manner as in the intervention group) will be administered to participants in the comparator group with Type-2 Diabetes Mellitus along with conventional anti-diabetic medicines for a time period of 6 months. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Diagnosed cases of Type-2 Diabetes Mellitus taking conventional anti-diabetic medications.
2.Participants with HbA1C levels more than 6.5%.
 
 
ExclusionCriteria 
Details  1.Pregnant women and lactating mothers.
2.Cases with known underlying immune deficiencies or serious illness.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The changes in HbA1C values.  Baseline, 6 months (Conclusion of the study). 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the FBS and PPBS levels.  Baseline, 6 months(Conclusion of the study). 
Changes in the quality of life will be assessed using the Quality of Life Instrument for Indian Diabetes Patients (QOLID) Questionnaire  Baseline, 6 months (Conclusion of the study). 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   14/03/2024 
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="1"
Months="6"
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   This study is a single blind randomized controlled clinical trial to find out the effectiveness of the Individualized Homoeopathic Medicines in LM potencies as an adjuvant to conventional medicines in the management of Type-2 Diabetes Mellitus . The primary outcome is to assess the changes in glycaemic control in the participants with T2DM after the administration of Individualized Homoeopathic Medicines in LM potencies as an adjuvant to conventional medicines compared to those who are taking conventional medicines with placebo. The secondary outcomes are to measure the  changes in the FBS and PPBS levels and changes in the quality of life using the Quality of Life Instrument for Indian Diabetes Patients (QOLID) Questionnaire at the baseline and at the conclusion of the study.The study duration is 1 year 6 months (inclusive of enrollment period of 1 year and a period of 6 months for the follow-up).  
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