| CTRI Number |
CTRI/2024/04/066246 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic medicines for diabetes |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines on glycemic control in type II diabetes mellitus in the mutual context of standard care |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1307-1900 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhranil Saha |
| Designation |
Lecturer |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Repertory, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
8777382128 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soumya Bhattacharyya |
| Designation |
Lecturer |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Materia Medica, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9836998171 |
| Fax |
|
| Email |
soumya.bh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soumya Bhattacharyya |
| Designation |
Lecturer |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Materia Medica, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9836998171 |
| Fax |
|
| Email |
soumya.bh@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College & Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal |
| Department of Science & Technology and Biotechnology , Govt of West Bengal, Vigyan Chetana Bhavan, Salt Lake, DD 26/B, Sector-1, Kolkata 700064 |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology and Biotechnology |
| Address |
Vigyan Chetana Bhavan, Salt Lake, DD 26/B, Sector-1, Kolkata 700064 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| D N De Homoeopathic Medical College Hospital |
12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Subhranil Saha |
D N De Homoeopathic Medical College and Hospital |
OPD no. 01 (Medicine), 10 (Research OPD), Dept. of Repertory and Materia Medica, 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL |
8777382128
drsubhranilsaha@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical - looking placebos plus standard antidiabetic care |
This arm will receive placebo
plus standard anti-diabetic care (oral monotherapy, combination
therapy, or insulin) will be continued as per the prescription of the
consultant diabetologist. Dietary advice will be given by the registered
dietician. Lifestyle management including stress reduction, yoga
practices, dietary restrictions, and enhanced physical activity will be
advised and compliance will be checked at a regular intervals of 15 days. The placebo is identical in appearance to the verum. Each dose of placebo will consist of 3-4 globules (no. 40) of cane sugar, moistened with rectified spirit, to be taken orally on a clean tongue with an empty stomach; dosage and repetition depend upon the individual requirement of the cases. Duration of treatment: 6 months. |
| Intervention |
Individualized homoeopathic medicines in centesiml potencies plus standard antidiabetic care |
This group will receive
homoeopathic medicines plus standard antidiabetic care. Individualized Homoeopathic Medicines (IHMs) will be
administered in centesimal potencies, as decided appropriate to the case
or condition. In the centesimal scale, each dose will consist of 3-4
globules (no. 40) of cane sugar, moistened with the indicated medicine
(preserved in 90% v/v ethanol), to be taken orally on the clean tongue
with an empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain
from handling the globules or from eating, drinking, smoking, or brushing their teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion taking into
account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, and repertorization using
HOMPATH® or RADAR® software when required with due
consultation of Materia Medica and due consensus among three
homoeopaths. All medicines will be procured from a Good
Manufacturing Practice (GMP)-certified firm. Standard antidiabetic medicines (oral monotherapy, combination
therapy, or insulin) will be continued as per the prescription of the
consultant diabetologist. Dietary advice will be given by the registered dietician. Lifestyle management including stress reduction, yoga practices, dietary restrictions, and enhanced physical activity will be advised and compliance will be checked at a regular intervals of 15 days.
Duration of treatment: 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Cases suffering from diabetes mellitus type II (2021 ICD-10-CM diagnosis code E11.9)
2) FBS more than 126 mg/dl; PPBS more than 200 mg per dl; HbA1c% more than 6.5 (ADA criteria)
3) Age between 18 and 65 years
4) Participants of either sex including transgender
5) Literate patients; ability to read and write in Bengali and/or English |
|
| ExclusionCriteria |
| Details |
1) Excessive blood glucose, FBS more than 300 mg per dl, PPBS more than 450 mg per dl
2) Participants with type I DM
3) Diagnosed cases of unstable psychiatric illness or other uncontrolled or life threatening illness affecting the quality of life or any organ failure
4) Pregnant, puerperal, and lactating women
5) Self-reported immune-compromised state
6) Tobacco, alcohol, or any kind of substance abuse and/or dependence
7) Undergoing homoeopathic treatment for any chronic disease within last 6 months
8) Participants denying written informed consent |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood glycosylated hemoglobin percentage (HbA1c%) |
Baseline, after 3 months, and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fasting blood sugar (FBS) |
Baseline, then every month, up to 6 months |
| Post-prandial blood sugar (PPBS) |
Baseline, then every month, up to 6 months |
| Lipid profile (triglyceride, total cholesterol, HDL, LDL, VLDL) |
Baseline, then after 3 months, and after 6 months |
| Serum Urea, Creatinine, Uric acid |
Baseline, then after 3 months, and after 6 months |
| Urine routine and microscopy |
Baseline, then after 3 months, and after 6 months |
| Diabetes Symptom Checklist: Revised (DSC-R) score |
Baseline, then every month, up to 6 months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="5"
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 - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [drsubhranilsaha@hotmail.com].
- For how long will this data be available start date provided 01-07-2027 and end date provided 30-06-2032?
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
|
Diabetes mellitus type 2 (DM2) is one of the costliest diseases due to the population size at risk and the fact that diabetes is a risk factor for almost all other chronic diseases. About 382 million individuals globally are diagnosed with DM2, which will increase to over 430 million by 2030. The disease burden is expected to increase, primarily in developing countries. This trial is aimed at evaluating the efficacy and safety of individualized homeopathic medicines (IHMs) in glycemic control in type 2 diabetes mellitus in the mutual context of standard care. The participants will be allocated to either verum (IHMs plus standard care) or control (placebo plus standard care) in a 1:1 ratio and will continue their usual antidiabetic medicines and lifestyle management. Blood HbA1c% will be the primary efficacy endpoint. Secondary measures include fasting and postprandial blood sugar, lipid profile, liver enzymes, serum urea, creatinine, uric acid, urine routine and microscopy, and the diabetes symptoms checklist score. All the outcomes will be measured at baseline and then every month up to 6 months. Data analysis will follow the intention-to-treat approach and use appropriate statistical tests to detect group differences. The results will be published in a scientific journal. |