Homeopathic treatment of increased lipids in blood

Phase 2/3

Recruiting

Conditions: Hyperlipidemia, unspecified,

Registration Number: CTRI/2023/03/050266

Lead Sponsor: D N De Homoeopathic Medical College and Hospital

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 105

Inclusion Criteria

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 patientsâ€™ 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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Low-Density Lipoprotein Cholesterol (LDL-C)	At baseline, after 2 months and after 4 months of intervention

Secondary Outcome Measures

Name	Time	Method
Measure Yourself Medical Outcome Profile 2 (MYMOP-2) questionnaire	Every month, up to 4 months of intervention.
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
Modified Naranjo Criteria for Homoeopathy (MONARCH) version-2	After 4 months of intervention

Trial Locations

Locations (1): D N De Homoeopathic Medical College and Hospital
🇮🇳
Kolkata, WEST BENGAL, India
D N De Homoeopathic Medical College and Hospital
🇮🇳Kolkata, WEST BENGAL, India
Dr Preeti Bhandari
Principal investigator
9007657709
preetibhandari90@gmail.com