| CTRI Number |
CTRI/2023/03/050266 [Registered on: 02/03/2023] Trial Registered Prospectively |
| Last Modified On: |
03/03/2023 |
| 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 treatment of increased lipids in blood |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled trial of individualized homoeopathic medicines in adults with dyslipidaemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1288-6302 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Preeti Bhandari |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD PG1 and room no. 1 (Dept. of Medicine), D N De Homoeopathic Medical College and Hospital,12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007657709 |
| Fax |
|
| Email |
preetibhandari90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhasish Ganguly |
| Designation |
Professor and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD PG1 and room no. 1 (Dept. of Medicine), D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
dr.subhasish67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subhasish Ganguly |
| Designation |
Professor and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD PG1 and room no. 1 (Dept. of Medicine), D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
dr.subhasish67@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital,12 Gobinda Khatick Road,Tangra, Kolkata 700046 |
|
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Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12,Gobinda Khatick Road,Tangra, 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 Preeti Bhandari |
D N De Homoeopathic Medical College and Hospital |
OPD room no. PG1 (Dept. of Organon of Medicine), room no. 1 (Dept. of Medicine), room no. 10 (Research), 12, Gobinda Khatick Road,Tangra, Kolkata 700046
Kolkata
WEST BENGAL |
9007657709
preetibhandari90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebos plus concomitant care |
This group will receive placebo, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40, moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition (once or twice daily, as required and as appropriate) 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 teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All enrolled patients will receive advice on diet and lifestyle modification during 4 months of therapy. Dietary management for dyslipidemia include : (i) complex carbohydrates, (ii) intake of mono- and polyunsaturated fats in place of trans and saturated fat, (iii) addition of foods like soluble fibre, plant sterols, etc., and (iv) stoppage of alcohol consumption, plus recommendations of regular exercise of 30-60 minutes duration for 3-5 times per week. Duration of therapy: 4 months. Route of administration: Per oral. |
| Intervention |
Individualized homeopathic medicines in centesimal potencies plus concomitant care |
Intervention is planned as administering the indicated homeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40, moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition (once or twice daily, as required and as appropriate) 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 teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All enrolled patients will receive advice on diet and lifestyle modification during 4 months of therapy. Dietary management for dyslipidemia include : (i) complex carbohydrates, (ii) intake of mono- and polyunsaturated fats in place of trans and saturated fat, (iii) addition of foods like soluble fibre, plant sterols, etc., and (iv) stoppage of alcohol consumption, plus recommendations of regular exercise of 30-60 minutes duration for 3-5 times per week. Duration of therapy: 4 months. Route of administration: Per oral. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from newly diagnosed cases of dyslipidaemia with LDL-C levels of 100-189 mg/dl
2.Age between 18 and 65 years
3.Framingham risk score <20%
4.Literate patients’ ability to read English, Hindi and/or Bengali. (Illiterate patients will be interviewed by the investigators maintaining adequate privacy to fill up the scales/questionnaires).
5.Providing with written informed consent voluntarily. |
|
| ExclusionCriteria |
| Details |
1.Familial hypertriglyceridaemia.
2.Persons already taking lipid lowering agents.
3.History of myocardial infarction, stenting, coronary artery bypasses surgery or stroke.
4.Vulnerable population - unconscious, too sick for consultation, non-ambulatory, differently abled, terminally or critically ill patients, mentally incompetent people.
5.Uncontrolled hypertension, uncontrolled diabetes, nephritic syndrome, renal insufficiency, uncontrolled hypothyroidism, severe or active liver diseases or any other uncontrolled systemic diseases affecting quality of life or organ failure.
6.Diagnosed cases of unstable mental or psychiatric illness.
7.Tobacco chewing and/or smoking, alcoholism, and/or any other form(s) of substance abuse and/or dependence.
8.Pregnancy, puerperium, lactation.
9.Self-reported immuno-compromised state.
10.Undergoing homeopathic treatment for any chronic disease within the last 6 months.
11.Simultaneous participation in any other clinical trials. |
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Low-Density Lipoprotein Cholesterol (LDL-C) |
At baseline, after 2 months and after 4 months of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum Triglycerides (TGs), Total cholesterol, Very-Low-Density Lipoprotein cholesterol (VLDL-C), High-density Lipoprotein cholesterol (HDL-C) |
At baseline, after 2 months and after 4 months of intervention |
| Measure Yourself Medical Outcome Profile 2 (MYMOP-2) questionnaire |
Every month, up to 4 months of intervention. |
| Modified Naranjo Criteria for Homoeopathy (MONARCH) version-2 |
After 4 months of intervention |
|
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Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
06/03/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet;to be published later |
|
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
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- 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 [preetibhandari90@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2031?
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
|
Dyslipidaemia, commonly defined as an abnormal levels of cholesterol such as low-density lipoprotein cholesterol(LDL-C), total cholesterol, triglycerides, very low-density lipoprotein cholesterol(VLDL-C) and high-density lipoprotein cholesterol (HDL-C) concentration or some combination of these in the blood. Dyslipidaemia, a major independent risk factor for cardiovascular diseases (CVDs) have become a growing burden across the globe, especially in the developing countries that alone account for 80% of the global CVD mortality.The risk of developing CVD increases two-fold when dyslipidaemia sets in. Dietary and lifestyle modification to prevent dyslipidaemia is now a global challenge due to a lack of health awareness among the population in countries like India. Though the use of homeopathic medicines is prevalent globally to treat the condition, rigorous research evidence in support of homeopathy in dyslipidaemia has remained compromised. 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 105 adults suffering from Dyslipidaemia, and will be randomized in a 2:1 allocation ratio, following one of the two interventions i.e. individualized homeopathic 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, to be measured at baseline, after 2 months and after 4 months of treatment. Secondary outcome measures are blood lipid profile (i.e. TGs, Total cholesterol, VLDL-C, HDL-C), MYMOP-2 and MONARCH-2. Lipid profile will be measured at baseline, after 2 months and after 4 months of treatment. MYMOP-2 will be measured at baseline and every follow-up, up to 4 months of intervention. MONARCH-2 will be measured at the end of the treatment (after 4 months of intervention). Comparative analysis will be carried out on Intention To Treat (ITT) basis to detect group differences. Results will be published in scientific journals.
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