| CTRI Number |
CTRI/2025/08/093949 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Homoeopathic medicines for high blood sugar in adults |
|
Scientific Title of Study
|
A series of n-of-1 trials exploring the efficacy of individualized homeopathic
medicines in LM potencies along with standard of care on glycemic control in type 2 diabetes mellitus in adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1327-5182 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rithika Padhi |
| Designation |
Postgraduate Trainee |
| Affiliation |
D.N.DE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of repertory and case taking OPD NO PG3 12, Gobinda Khatick road, Kolkata 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
9875310854 |
| Fax |
|
| Email |
rithikapadhi853@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rithika Padhi |
| Designation |
Postgraduate Trainee |
| Affiliation |
D.N.DE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of repertory and case taking OPD NO PG3 12, Gobinda Khatick road, Kolkata 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
9875310854 |
| Fax |
|
| Email |
rithikapadhi853@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHUBHAMOY GHOSH |
| Designation |
Professor and Head of Department of pathology and microbiology |
| Affiliation |
D.N.DE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
12, Gobinda Khatick road, Kolkata 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
9831034229 |
| Fax |
|
| Email |
shubhamoy67@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick road, Seal lane, Tangra, Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick road, Seal lane, Tangra, Kolkata 700046 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rithika Padhi |
D N De homoeopathic medical college and hospital |
Department of Homoeopathic Repertory and Case Taking, Opd 13 Pg3 and medicine opd 1
12 Gobinda Khatick road Kolkata, West Bengal 700046
Kolkata
WEST BENGAL |
9875310854
rithikapadhi853@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 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 of Care with concomitant care |
placebo indistinguishable solution containing 70ml of 90 percent alcohol is administered in the same posology as the verum medication. Standard of care in type2 DM involves antidiabetic medications (Metformin sulfonylureas meglitinides gliptins alpha glucosidase inhibitors) as per patient profile and risk factors. All the enrolled patients will receive advices on general management according to ADA guidelines emphasize a comprehensive approach for weight loss DASH diet and physical activities along with yoga postures helpful in type2 Diabetes mellitus conditions as per guidelines of Moraji desai national institute of Yoga Ministry of Ayush Duration of intervention 4 months |
| Intervention |
Individualized Homoeopathic Medicine plus Standard of Care with concomitant care |
Intervention is planned as administering individualized homeopathic medicines in 50 millesimal potencies, as decided appropriate to the case or condition. In 50 millesimal scale, a single medicated cane sugar globule of poppy seed size (no. 10) will be dissolved in 70 ml distilled water with addition of 3 drops of 90 percent v/v ethanol; 14 doses to be marked on the vial( organon 6th edition paragraph 248) ; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup. All medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. The participant should apply ten succussions to the bottle before each dose (Organon, 6th ed., paragraph 248). As the participant improves, the selected homeopathic medication will be further administered in step by step ascending fifty millesimal potencies (LM1-LM2-LM3-LM4...), wherein each potency will be used for a maximum period of two weeks. Standard of care in type2 DM involves antidiabetic medications (Metformin sulfonylureas meglitinides gliptins alpha glucosidase inhibitors) as per patient profile and risk factors. All the enrolled patients will receive advices on general management according to ADA guidelines emphasize a comprehensive approach for weight loss DASH diet and physical activities along with yoga postures helpful in type2 Diabetes mellitus conditions as per guidelines of Moraji desai national institute of Yoga Ministry of Ayush Duration of intervention 4 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Cases suffering from type 2 DM (ICD 10 code E11) for more than equals to 1 year (as per ADA criteria)
PPG (postprandial plasma glucose) more than equals to 200 mg/dl.
HbA1c percent more than equals to 6.5 (ADA criteria) at screening and less than 10.5.
Adults- men or women or transgender with T2DM
BMI more than 23 and less than 45 kg/m2.
Patient on stable conventional screening, anti - diabetic therapy (oral diabetic agents) for more than 3months.
|
|
| ExclusionCriteria |
| Details |
Excessive blood glucose, FBS more than 300 mg/dl, PPBS more than 450 mg/dl
Participants with type I DM or secondary diabetes (e.g., pancreatic or steroid-induced)
Diagnosed cases of unstable psychiatric illness or other uncontrolled or life threatening illness affecting the quality of life or any organ failure (eg: severe liver or kidney disease, serum creatinine more than 1.4mg/dl in women and more than 1.5mg/dl in men)
women of pregnancy, puerperium, lactation.
Homeopathic treatment for any chronic disease within last 6 months
uncontrolled HTN or severe Dyslipidaemia or diabetic and taking insulin for 6 consecutive days within the prior year
Vulnerable population – unconscious, non - ambulatory, too sick for consultation, differently abled, terminally ill or critically ill, mentally incompetent people.
Tobacco, alcohol, or any kind of substance abuse and/or dependence
participation in another clinical trails
Self-reported immune-compromised state.
|
|
|
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 |
| Postprandial Plasma Glucose (PPG) |
At Baseline every 17 days upto 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Diabetes Quality of Life – 17 questionnaire, (MDQoL-17) |
At Baseline Every 17 days upto 4 months |
| HbA1c |
at Baseline and after 3 months |
| lipid profile (LDL, HDL and their ratio) |
At baseline Every 17 days upto 4 months |
| Microalbumin(urine) |
At Baseline Every 17 days upto 4 months |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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)
|
10/09/2025 |
| 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-identification.
- 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 [rithikapadhi853@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
|
This study is designed whether IHMs in LM Potencies can produce any significant effect beyond placebo in Postprandial Plasma Glucose in the treatment of type2 Diabetes Mellitus in adults after four months of intervention, using an N-of-1 trial design. The trial will be conducted at the Outpatient Department of D. N. De Homoeopathic Medical College and Hospital, Kolkata. Participants will receive personalized homeopathic medicines, with each treatment cycle followed by a washout phase to assess individual responses. The primary outcome is the change Postprandial Plasma Glucose from baseline. Secondary outcomes include improvement in quality of life measured by the MDQoL 17 (modified diabetes quality of life ) scale. Additionally, investigation including HbA1c, lipid profile( LDL, HDL, LDL HDL Ratio ), and Microalbumin (urine) will be conducted to monitor end-organ damage associated with hypertension. This trial aims to assess the individualized therapeutic response to homeopathy in type2 Diabetes mellitus and explore its potential as a safe, complementary approach in type2 Diabetes mellitus care. |