| CTRI Number |
CTRI/2025/08/093559 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment of nnumbness, tingling, aching, and burning pain, hyperesthesia, and weakness of limbs in adults with high blood sugar. |
|
Scientific Title of Study
|
Efficacy of individualized homeopathic medicines in the treatment of peripheral diabetic neuropathy in adults A double-blind, randomized, placebo-controlled trial with mutual antidiabetic standard care |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1326-9384 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samiul Alam |
| Designation |
POSTGRADUATE TRAINEE |
| Affiliation |
D N DE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata 700046
12 GOBINDA KHATICK ROAD TANGRA KOLKATA 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
6290039839 |
| Fax |
|
| Email |
asamiul504@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Samiul Alam |
| Designation |
POSTGRADUATE TRAINEE |
| Affiliation |
D N DE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata 700046
12 GOBINDA KHATICK ROAD TANGRA KOLKATA 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
6290039839 |
| Fax |
|
| Email |
asamiul504@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUBHRANIL SAHA |
| Designation |
Lecturer |
| Affiliation |
D N DE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata 700046
12 GOBINDA KHATICK ROAD TANGRA KOLKATA 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
8777382128 |
| Fax |
|
| Email |
drsubhranilsaha@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N DE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
12 GOBINDA KHATICK ROAD KOLKATA 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12 Gobinda Khatick Road, Kolkata 700046 |
| 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 Samiul Alam |
D N De Homoeopathic Medical College and Hospital |
Department of Homoeopathic Repertory and Case taking, PG-3 OPD, 12 Gobinda Khatick Road
Kolkata
WEST BENGAL |
6290039839
asamiul504@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical looking Placebo plus Standard care and Concomitant care |
This arm will receive placebo, identical in appearance with the verum. Each dose of placebo shall consist of 4 globules (no. 40) of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Management guidelines will be given as in the experimental arm. Duration of therapy: 3 months. Both medicines and placebos will be re-packed in identical glass bottles and labelled with code, name of the medicine, potency and will be dispensed according to the random number list.
Concomitant care: During the three months of the intervention, all enrolled patients will receive dietary advice and lifestyle modifications, as instructed by a conventionally trained dietician. Reminding the participants verbally over the phone once a week and during each follow-up visit will ensure that they follow the advice to take standart care and home exercises etc. Standard care: Patient will receive standard care of treatment for hyperglycemia by a conventionally trained endocrinologist or diabetologist. Duration of therapy 3 months. |
| Intervention |
Individualized homoeopathic medicines plus Standard care and Concomitant care |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). 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 a clean tongue in 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 considering presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH/RADAR software when required with due consultation of Materia Medica and due consensus among three homoeopaths. The following remedies have been shortlisted from the already published trials: Lycopodium clavatum, Sulphur, Arsenicum album, Acidum posphoricum, Phosphorus, Natrum muriaticum, Natrum sulphuricum, Acidum nitricum, Medorrhinum, Causticum, Thuja occidentalis, and Lachesis mutus. After repertorization, the final selection will be made from a checklist of these 12 remedies with their characteristic and keynote symptoms obtained from sourcebooks and further confirmed by relatively high likelihood ratio, whenever available. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm.
Concomitant care: During the three months of the intervention, all enrolled patients will receive dietary advice and lifestyle modifications, as instructed by a conventionally trained dietician. Reminding the participants verbally over the phone once a week and during each follow-up visit will ensure that they follow the advice to take standart care and home exercises etc.
Standard care: Patient will receive standard care of treatment for hyperglycemia by a conventionally trained endocrinologist or diabetologist.
Duration of therapy 3 months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged of 30-65 years
2. Participant of either sex or transgender.
3. person who had been diagnosed with diabetic neuropathy for at least 3 months.
4. DNE score greater than 3.
|
|
| ExclusionCriteria |
| Details |
1. Individuals with other neurological disorders.
2. Abnormal gait, loss of arch with multiple fractures in tarsal bones wrist, foot drop.
3. Diabetic complications (such as retinopathy or renal involvement with history of recurrent acute complaints like hypoglycaemia, keto-acidosis).
4. Self-reported immune-compromised state.
5. Tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
6. Pregnant or lactating women, unstable mental health.
7. Those who requiring insulin with an HbA1c equal or more than 10.
8. Participants who had received homeopathic treatment for chronic diseases in the last 6 months or were critically ill were also excluded from the study.
9. patient not providing with written informed consent voluntarily.
10. Vulnerable population-Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
|
|
|
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 |
| Neuropathy total symptom score(NTSS-6) |
Baseline, every months up to three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Douleur Neuropathique 4 Questions (DN4) scale |
Baseline, every months up to three months |
| Diabetic Neuropathy Examination (DNE) score |
Baseline, every months up to three months |
| Measure Yourself Medical outcome Profile version 2 (MYMOP-2) score |
Baseline, every months up to three months |
Fasting blood sugar (FBS),
Postprandial blood sugar (PPBS) |
Baseline, every months up to three months |
| HbA1C%, lipid profile, liver enzymes (ALT, AST), urea, creatinine, urine profile |
At baseline and after three months of interventions |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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)
|
05/09/2025 |
| 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) |
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 - 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 [asamiul504@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
|
Diabetic neuropathy (ICD E11.40) is defined as the presence
of symptoms and/or signs of peripheral nerve dysfunction in a patient with
diabetes, after the exclusion of other causes. In course of diabetes, exceeding
50% people eventually develop peripheral diabetic neuropathy . Though the use
of homoeopathic medicines is extensive globally to treat the condition,
diligent research evidence in favor of homoeopathy is not well Marked. So, we
intend to undertake the research to evaluate the efficacy and safety of
homoeopathic medicines in the treatment of PDN. A double blind randomized
placebo controlled trial will be conducted upon 142 middle aged individuals at
the outpatient of D.N.De homoeopathic medical college and hospital. Assessment
will be done by NTSS 6 scale [primary outcome], DN4, DNE, Measure Yourself
Medical outcome Profile version 2 (MYMOP-2) score, FBS and PPBS [secondary
outcome] to be measured at base line and every month up to 3 months. HbA1c %, ,
lipid profile, liver enzymes (ALT, AST), urea, creatinine, urine profile [secondary
outcome] at baseline and after 3 month of intervention. Comparative analysis
will be carried out to detect group difference (if any). |