| CTRI Number |
CTRI/2024/02/063065 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness Homoeopathic Medicines for Pre-diabetes |
|
Scientific Title of Study
|
Study to Compare Effectiveness of Potencies Within and Beyond Avogadro Limit of Individualised Homoeopathic Medicine among Pre-Diabetic Adults by Assessing Glycemic Control: An Open-Level Randomized Parallel-Arm Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1302-1628 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avidipta Hazra |
| Designation |
Under-graduate Student |
| Affiliation |
Metropolitan Homoeopathic Medical College and Hospital |
| Address |
Out-patient Department (Room No. 3) & Emergency Out-patient Department (Room no. 13), Hospital Division, Ramchandrapur, Sodepur
North Twentyfour Parganas
WEST BENGAL
700110
India |
| Phone |
6295628901 |
| Fax |
|
| Email |
avidipta.kurchi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debarsi Das |
| Designation |
Professor & HOD, Dept. of Organon of Medicine |
| Affiliation |
Metropolitan Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine, OPD No. 3 & Emergency OPD, Ramchandrapur, Sodepur
North Twentyfour Parganas
WEST BENGAL
700110
India |
| Phone |
8240821020 |
| Fax |
|
| Email |
drdebarsi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Avidipta Hazra |
| Designation |
Under-graduate Student |
| Affiliation |
Metropolitan Homoeopathic Medical College and Hospital |
| Address |
Out-patient Department (Room No. 3) & Emergency Out-patient Department (Room no. 13), Hospital Division, Ramchandrapur, Sodepur
North Twentyfour Parganas
WEST BENGAL
700110
India |
| Phone |
6295628901 |
| Fax |
|
| Email |
avidipta.kurchi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Metropolitan Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Metropolitan Homoeopathic Medical College and Hospital |
| Address |
Arunachal, Ramchandrapur, Sodepur, Kolkata-700110 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Debarsi Das |
Metropolitan Homoeopathic Medical College & Hospital |
Out-patient Department (Room No. 3) & Emergency Out-patient Department (Room No. 13), Hospital Division, Ramchandrapur, Sodepur
North Twentyfour Parganas
WEST BENGAL |
8240821020
drdebarsi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R739||Hyperglycemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualized homoeopathic medicines with potencies beyond Avogadro limit (potencies beyond 24X in decimal scale and 12CH in centesimal scale) |
Arm-2: Intervention is planned as administering indicated homoeopathic medicines according to sign & symptoms of patients beyond 24X potency of decimal scale or 12CH potency of centesimal scale. Each dose shall consist of 6-8 globules (no. 20) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol); taken orally on clean tongue; repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified company.
Duration of this therapy: 3 months |
| Intervention |
Individualized homoeopathic medicines with potencies within Avogadro limit (potencies within 24X in decimal scale and 12CH in centesimal scale) |
Arm-1: Intervention is planned as administering indicated homoeopathic medicines according to sign & symptoms of patients within/equal 24X potency of decimal scale or 12CH potency of centesimal scale.
Each dose shall consist of 6-8 globules (no. 20) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol); taken orally on clean tongue; repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified company.
Duration of this therapy: 3 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient age within 20-79years, both male and female. 2. Indian Diabetic Risk Score (IDRS) above/equal to 60. 3. Impaired glucose regulation i.e. fasting plasma glucose concentration value 100-125mg/dL and/or two hrs. post 75gm glucose load plasma glucose value 140-199mg/dL. 4. Patients with written consent to participate in this study. 5. Literate patients. |
|
| ExclusionCriteria |
| Details |
1. Patient suffering from uncontrolled systemic illness, life-threatening infections or any vital organ failure/s
2. Patient already undergoing homoeopathic treatment for any chronic disease
3. Patient with self-reported immune-compromised states
4. Pregnant women/lactating mother
5. Patient without consent to take part or Illiterate patient |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycosylated hemoglobin (HbA1C) |
Baseline, after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fasting blood glucose level |
Baseline, after 3 months |
| Blood glucose level after 2 hours of 75 gm glucose load |
Baseline, after 3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/02/2024 |
| Date of Study Completion (India) |
23/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [avidipta.kurchi@gmail.com].
- For how long will this data be available start date provided 01-12-2024 and end date provided 30-11-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Pre-diabetes is an intermediate state of hyperglycemia characterized by elevated blood glucose concentrations, such as impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and elevated glycated haemoglobin A1c (HbA1c). According to the American Diabetes Association (ADA), Pre-diabetic conditions can be detected by Oral Glucose Tolerance Test ranging between 140 and 199 mg/dL and/or Fasting Blood Sugar ranging between 100 and 125 mg/dL and/or glycated haemoglobin(HbA1c) percentages of 5.7 to 6.4%. It is a major contributor to the global diabetes epidemic and is a growing global
health concern today. It Half of pre-diabetic patients has tendency to converted into Type-2 Diabetes Mellitus (T2DM).
Avogadro limit is becoming a hot topic to criticise diluted homoeopathic medicine by ignoring
its dynamic curing action on real life. This study aims to discard the ongoing surrounding
debate about the mechanisms of action in homeopathy by comparing the effectiveness of
different potencies within and beyond the Avogadro limit. The results of this trial could shed
light on whether potencies beyond the Avogadro limit have any clinically meaningful impact
on glycemic control in pre-diabetic adults compared to those within the Avogadro limit. |