| CTRI Number |
CTRI/2025/08/093014 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic medicines for patients with high blood sugar |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines on the glycemic control in prediabetic adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1326-4679 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sk Saklin Mustak |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
7384169831 |
| Fax |
|
| Email |
dr.saklin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sk Saklin Mustak |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road
WEST BENGAL
700046
India |
| Phone |
7384169831 |
| Fax |
|
| Email |
dr.saklin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohan Giri |
| Designation |
Professor and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Practice of Medicine, OPD no. 1 (Medicine) and PG5, 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433904265 |
| Fax |
|
| Email |
giri.drmohan@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal, 12, Gobinda Khatick Road, Kolkata 700046, West Bengal |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Kolkata 700046, West Bengal |
| Type of Sponsor |
Government 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 Sk Saklin Mustak |
D N De Homoeopathic Medical college and Hospital |
Dept. of Practice of Medicine, OPD no. 1 and PG-5, 12, Gobinda Khatick Road
Kolkata
WEST BENGAL |
7384169831
dr.saklin@gmail.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 & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R73||Elevated blood glucose level, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebo plus concomitant care |
This arm will receive a placebo. The placebo is identical in appearance to the verum. Each dose of placebo will consist of 3-4 globules (No. 30) of cane sugar, moistened with rectified spirit, to be taken orally on an empty stomach with a clean tongue. The dosage and frequency of repetition depend on the individuals specific needs. Management guidelines will be given as in the experimental arm. Both medicines and placebos will be repacked in identical glass bottles, labelled with a code, the name of the medicine, and its potency, and will be dispensed according to the random number list. During the three-month intervention period, all enrolled patients will receive advice on dietary guidelines and lifestyle modification. Reminding participants verbally over the phone once a week and during each follow-up visit will help ensure they follow the advice. Duration of therapy: 3 months |
| Intervention |
Individualized homeopathic medicines plus concomitant care |
The intervention is planned to involve administering indicated homeopathic medicines in centesimal potencies (CH). Each dose will consist of 3-4 globules (No. 30) of cane sugar, moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on an empty stomach; dosage and repetition will depend on the individuals requirements. 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 them. Single, individualized medicine will be prescribed on each occasion, considering the totality of presenting symptoms, clinical history details, constitutional features, miasmatic expressions, and repertorization using HOMPATH/RADAR software when required, with due consultation of the Materia Medica and consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Provision will be made to adjust the medicines or potencies and dosage in subsequent visits whenever required, following the principles of classical homeopathy, and such instances will be compared between groups. During the three-month intervention period, all enrolled patients will receive advice on dietary guidelines and lifestyle modification. Reminding participants verbally over the phone once a week and during each follow-up visit will help ensure they follow the advice. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases with newly diagnosed prediabetes
2. FBS 100-125 mg/dl and/or PPBS 140-199 mg/dl and/or HbA1c% 5.7-6.4 (American Diabetes Association)
3. Age between 18 and 65 years
4. Participants of either sex or transgender |
|
| ExclusionCriteria |
| Details |
1. Diagnosed cases of type I and type II DM.
2. Not providing written informed consent for participation.
3. Pregnant, puerperal, and lactating women.
4. Self-reported immunocompromised state, AIDS, hepatitis, etc.
5. Vulnerable population: Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill, or critically ill patients and mentally incompetent people.
6. Uncontrolled hypertension, nephritic syndrome, renal insufficiency, uncontrolled hypothyroidism, severe or active liver diseases, or any other uncontrolled systemic diseases affecting the quality of life or organ failure.
7. Females who regularly take oral contraceptive pills (OCPs) or combined oral contraceptives (COCs).
8. Patient under tobacco chewing and/or smoking, alcoholism, and/or any other form(s) of substance abuse and/or dependence (TAPS tool).
9. Undergoing homeopathic treatment for any chronic disease within the last 6 months.
10. Simultaneous participation in any other clinical trials. |
|
|
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%) |
At baseline, and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FBS and PPBS (post-2-hour, 75 g OGTT) |
At baseline, monthly, up to 3 months |
| Lipid profile, liver enzymes (ALT and AST) |
At baseline, and after 3 months |
| Measure Yourself Medical Outcome Profile version 2.0 (MYMOP-2) |
At baseline, monthly, up to 3 months |
| Short Form 12 (SF-12) health survey questionnaire |
At baseline, monthly, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
01/09/2025 |
| 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 Applicable |
| 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 - 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 - Study Protocol
Response - Statistical Analysis Plan
- 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 [dr.saklin@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
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
|
Prediabetes is an intermediate state of hyperglycemia characterized by elevated blood glucose with impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) and/or increased glycated hemoglobin (HbA1c) percentage. The ADA diagnoses prediabetes with an FBS of 100-125 mg/dl, an OGTT of 140-199 mg/dl, and/or an HbA1c value of 5.7-6.4%. Prediabetic individuals are at higher risk of developing T2DM, cardiovascular disease, stroke, microvascular, and macrovascular complications compared to normoglycemic individuals. Prediabetes in adults often leads to increased blood sugar levels without any symptoms, requiring proper screening and monitoring. Symptoms may include increased appetite, weight loss, raised BMI, fatigue, vision issues, and dermatological infections. Lifestyle modifications and metformin are the mainstream therapies for preventing T2DM in individuals with prediabetes. But they temporarily lower blood sugar levels but do not alter disease progression. 20-30% of patients may experience some adverse effects, including nausea, vomiting, diarrhea, bloating, and abdominal pain. [4] Previously, few clinical trials have been done in homeopathy, most of which have shown promising results in lowering blood glycemic parameters through homeopathic intervention in the treatment of prediabetes. Previous randomized, placebo-controlled trials are conducted at a 1:1 ratio. However, further studies are needed to confirm the efficacy of IHMs in prediabetic adults by replicating the existing trials with a larger sample size. This trial is merely another attempt to detect and prove the efficacy of IHMs in reducing blood glycemic parameters by a 2:1 randomized ratio in 135 participants with prediabetes at the OPD of D.N. De Homoeopathic Medical College and Hospital. Assessment will be done by estimating the serum HbA1c% (primary), FBS, OGTT, lipid profile, liver enzymes (ALT and AST), SF-12, and MYMOP2 questionnaires (secondary), which will be measured monthly for up to 3 months. A comparative analysis will be conducted to detect group differences. |