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CTRI Number  CTRI/2025/08/093037 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 12/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Two Homoeopathic Treatments for Improving Blood Sugar Levels in Adults with Type 2 Diabetes 
Scientific Title of Study   A Double-Blind, Randomized Controlled Trial Comparing Helonias Dioica 6C And Individualized Homoeopathic Medicine on Glycemic Control Using HbA1c, FBS and DSC-R Score in Adults with Type 2 Diabetes Mellitus 
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 AGHOSH B PRASAD 
Designation  Junior Resident, Department of Materia Medica 
Affiliation  White Memorial Homoeo Medical College 
Address  Department of Homoeopathic Materia Medica, White Memorial Homoeo Medical College, Attoor, Veeyanoor PO

Kanniyakumari
TAMIL NADU
629177
India 
Phone  9400076226  
Fax    
Email  aghoshbprasad100@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR BINYA B V 
Designation  Associate Professor, Department of Materia Medica 
Affiliation  White Memorial Homoeo Medical College 
Address  Department of Homoeopathic Materia Medica, White Memorial Homoeo Medical College, Attoor, Veeyanoor PO

Kanniyakumari
TAMIL NADU
629177
India 
Phone  9497267843  
Fax    
Email  binayabenjamin@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR BINYA B V 
Designation  Associate Professor, Department of Materia Medica 
Affiliation  White Memorial Homoeo Medical College 
Address  Department of Homoeopathic Materia Medica, White Memorial Homoeo Medical College, Attoor, Veeyanoor PO

Kanniyakumari
TAMIL NADU
629177
India 
Phone  9497267843  
Fax    
Email  binayabenjamin@gmail.com  
 
Source of Monetary or Material Support  
Department of Homoeopathic Materia Medica, White Memorial Homoeo Medical College, Attoor, Veeyanoor PO, Kanniyakumari, Tamilnadu, India Pin: 629177 
 
Primary Sponsor  
Name  Department of Materia Medica White Memorial Homoeo Medical College and Hospital 
Address  Department of Homoeopathic Materia Medica, White Memorial Homoeo Medical College, Attoor, Veeyanoor PO, Kanniyakumari, Tamilnadu, India Pin 629177 
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 AGHOSH B PRASAD  White Memorial Homoeo Medical College and Hospital  Department of Homoeopathic Materia Medica, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor PO, Kanniyakumari, Tamilnadu, India Pin 629177
Kanniyakumari
TAMIL NADU 		 9400076226

aghoshbprasad100@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL ETHICS COMMITTEE WMHMCH-EC  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  Helonias dioica 6C  Helonias dioica 6C, 4 medicated globules (#40 size), administered as a single dose sublingually every morning on an empty stomach. The medicine is to be stopped once definite improvement (amelioration) or a homeopathic aggravation occurs. The intervention will be administered for a period of 3 months. All participants will also receive standardized diet, lifestyle, and yoga advice. 
Comparator Agent  Individualized Homoeopathic Medicine  A single homoeopathic medicine (typically 30C, 200C, or LM potencies) selected based on classical homoeopathic case-taking and principles of Organon of Medicine. Dosage and repetition will be individualized (e.g., single dose, wait and watch). The intervention will be administered for a period of 3 months. All participants will also receive standardized diet, lifestyle, and yoga advice. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diagnosed with Type 2 Diabetes Mellitus according to ICMR 2018 diagnostic criteria. Either: 1) Newly diagnosed T2DM (diagnosed within the last 6 months) and entirely naïve to both oral anti-diabetic drugs (OADs) and insulin therapy, OR 2) Previously diagnosed T2DM but currently managed solely with diet and lifestyle modifications for at least the past 3 months (i.e., not on any OADs or insulin for at least 3 months). Baseline HbA1c between 6.5% and 8.0% (inclusive). Willing and able to provide written informed consent and adhere to study procedures. 
 
ExclusionCriteria 
Details  Patients currently taking or having taken any conventional anti-diabetic medication (oral anti-diabetic drugs OR insulin) within the last 3 months. History of requiring continuous or long-term insulin therapy for glycaemic control. Type 1 Diabetes Mellitus, Latent Autoimmune Diabetes in Adults (LADA), Maturity Onset Diabetes of the Young (MODY), or secondary diabetes. Baseline HbA1c less than 6.5% or greater than 8.0%. Severe uncontrolled hypertension (systolic BP greater than 180 mmHg or diastolic BP greater than 110 mmHg despite medication). Presence of severe diabetic complications: proliferative retinopathy requiring active treatment, end-stage renal disease (eGFR less than 30 ml/min/1.73m²), active Charcot foot, major cardiovascular event within the last 6 months. Significant hepatic dysfunction (ALT or AST greater than 3 times the upper limit of normal). Known history of severe psychiatric illness that may interfere with informed consent or study compliance. Pregnant or lactating women, or women planning pregnancy during the study period. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change in serum Glycated Hemoglobin (HbA1c) from baseline.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in Diabetes Symptom Checklist-Revised (DSC-R) total score from baseline.  3 months 
Mean change in Fasting Blood Sugar (FBS) from baseline.  1 month, 2 months, and 3 months 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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   N/A 
Date of First Enrollment (India)   05/10/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aghoshbprasad100@gmail.com].

  6. For how long will this data be available start date provided 05-11-2026 and end date provided 05-11-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Background: Type 2 Diabetes Mellitus (T2DM) is a significant and growing health problem in India. Many patients seek homeopathic treatment, which typically involves either a specific remedy for the condition or a fully individualized remedy based on the patient’s unique symptoms. However, there is a lack of high-quality clinical trial evidence comparing the effectiveness of these two common homeopathic approaches.

Hypothesis: This study hypothesizes that there will be a statistically significant difference in the improvement of glycemic control (measured by HbA1c) between patients treated with the specific homeopathic remedy Helonias dioica 6C and those treated with an individualized homeopathic medicine.

Methods: This is a prospective, double-blind, randomized controlled trial. A total of 74 adults (aged 35-65 years) with T2DM (HbA1c between 6.5 percent and 8.0 percent) who are not currently taking any conventional oral anti-diabetic drugs or insulin will be recruited. Participants will be randomly assigned to one of two groups. Arm A will receive Helonias dioica 6C, and Arm B (the active control group) will receive an individualized homeopathic medicine. Both groups will also receive standardized counseling on diet, lifestyle, and yoga. The primary outcome is the mean change in HbA1c from baseline to 3 months. Secondary outcomes include changes in Fasting Blood Sugar (FBS), diabetes-related symptoms (using the DSC-R score), and safety.

Aim: The study aims to provide evidence on the relative effectiveness and safety of these two classical homeopathic strategies for managing early T2DM.
 
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