| CTRI Number |
CTRI/2025/08/093315 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effects of homeopathic medicines on blood lipid profile in adults |
|
Scientific Title of Study
|
A double-blind, randomized placebo-controlled trial of individualized homeopathic medicines in the treatment of dyslipidaemia in adults |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1326-8573 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Greeshma Raj K P |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
12 Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9745873194 |
| Fax |
|
| Email |
greeshmarajkp95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Greeshma Raj K P |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
12 Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9745873194 |
| Fax |
|
| Email |
greeshmarajkp95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Veena Prakash Bharti |
| Designation |
Reader |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Practice of Medicine, OPD no 1 (medicine)and PG 5, 12 Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9231692840 |
| Fax |
|
| Email |
drvpbharti@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 West Bengal 700046 |
|
|
Primary Sponsor
|
| Name |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
12 Gobinda Khatick Road, Kolkata West Bengal 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 Greeshma Raj K P |
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 |
9745873194
greeshmarajkp95@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: E78||Disorders of lipoprotein metabolism and other lipidemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebo plus concomitant care |
This arm will get a placebo. The verum and the placebo have the same appearance. Three to four globules (no. 30) of cane sugar, moistened with rectified spirit, will make up each dose of the placebo, which should be given orally on an empty stomach and with a clean tongue. The quantity and frequency of administration will depend on the specific needs of each case. Both medications and a placebo will be repackaged in identical glass bottles, labelled with the medications name, code, and potency. The random number list will determine how the medications are distributed. Concomitant care : Dietary guidelines and lifestyle modification during 3 months of intervention will be given to all enrolled patients. Reminding the participants verbally over the phone once a week and during each follow-up visit will ensure that they follow the advice. Diet with Lifestyle modifications. All dietary recommendations are customized according to each participant’s socio-economic and cultural background under dietitian guidance. Duration of therapy 3 months.
|
| Intervention |
Individualized homeopathic medicines plus concomitant care |
Using centesimal potencies (CH) of approved homoeopathic medications is the intended intervention. The quantity and frequency of administration will depend on the specific needs of each patient. Each dose will consist of 3–4 globules (no. 30) of cane sugar moistened with the required medication (kept in 90% v/v ethanol) and eaten orally on a clean tongue in an empty stomach. Patients will be requested to suck the globules instead of just swallowing them, and they will be told not to handle the globules or eat, drink, smoke, or clean their teeth for 30 minutes after taking them. Considering the entirety of the presenting symptoms, clinical history, constitutional features, miasmatic expressions, and, when necessary, repertorization using HOMPATH/RADAR software, with due consultation of Materia Medica and due consensus among three homoeopaths, a single customized medication will be prescribed each time. All medications and other items will be purchased from a company that is certified by Good Manufacturing Practice (GMP).
Concomitant care :
Dietary guidelines and lifestyle modification during 3 months of intervention will be given to all enrolled patients. Reminding the participants verbally over the phone once a week and during each follow-up visit will ensure that they follow the advice. Diet with Lifestyle modifications. All dietary recommendations are customized according to each participant’s socio-economic
and cultural background under dietitian guidance.
Duration of therapy 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient suffering from newly diagnosed cases of dyslipidaemia with LDL-C levels of 100-189mg/dl
2. Framingham risk score less than 20%
3. Age between 18 and 65 years.
4. Participants of either sex or transgender.
|
|
| ExclusionCriteria |
| Details |
1. Patients not providing with written informed consent of participation.
2. Familial hypertriglyceridemia.
3. Person already taking lipid lowering agents.
4. History of myocardial infarction, stenting, coronary artery bypass surgery or stroke.
5. Pregnant, puerperal, and lactating women.
6. Non ambulatory patients
7. Undergoing homoeopathic treatment for any chronic disease within the last 6 months
8. Vulnerable population: Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, diagnosed cases of unstable mental or psychiatric illness and self-reported immune-compromised state.
9. Uncontrolled hypertension, uncontrolled diabetes, 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.
10. Habits of tobacco chewing and/or smoking, alcoholism, and/or any other form(s) of substance abuse and/or dependence (TAPS tool)
11. 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 LDL cholesterol level (LDL-C) |
At baseline, and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| total cholesterol (TC),Triglycerides(TGs),HDL,VLDL,FBS,PPBS and liver enzymes (AST and ALT) |
At baseline, and after 3 months |
| Short form 12(SF-12) health survey questionnaire |
At baseline, monthly, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
08/09/2025 |
| 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 Yet Recruiting |
| 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-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 [greeshmarajkp95@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
|
Dyslipidemias, in particular increased plasma LDL-cholesterol levels, are important risk factors for cardiovascular disease. Primary or family dyslipidemias are genetically determined, but secondary dyslipidemias are more frequently caused by other illnesses including diabetes mellitus, obesity, or an unhealthy lifestyle. The most prevalent kind of dyslipidaemia, hypercholesterolemia, is linked to a higher risk of cardiovascular disease. In 1990, raised plasma LDL-cholesterol levels were the 15th most important risk factor for death; by 2007, that number had risen to 11th, and by 2019, it had risen to the eighth . Previous research on the role of homoeopathic medicines in the treatment of dyslipidaemia offers promising yet inconclusive findings. Under such circumstances, we will intend to undertake this research project to ascertain the probable efficacy of Individualized Homoeopathic Medicines in comparison to placebo. This prospective, double blind, randomized, parallel-arm, placebo-controlled trial will be conducted on 100 adults suffering from Dyslipidaemia, and will be randomized in a 2:1 allocation ratio, following one of the two interventions i.e. Individualized Homoeopathic Medicines or identical-looking placebo, in the mutual context of concomitant care at the outpatient departments of D. N. De Homoeopathic Medical College and Hospital. Primary outcome measure is blood lipid profile (i.e. serum LDL- Cholesterol level), will be measured at baseline and after 3 months of treatment. Secondary outcome measures are blood lipid profile (i.e. TGs, Total cholesterol, VLDL-C, HDL-C), fasting blood sugar, post prandial blood sugar, 12 items short form questionnaire (SF-12). Lipid profile will be measured at baseline and after 3 months of treatment. SF-12 will be measured at baseline and every follow-up up to 3 months of intervention. Comparative analysis will be carried out on Intention to Treat (ITT) and Per protocol (PP) basis to detect group differences. |