Protocol for an open-label randomized controlled exploratory trial of Homoeopathy on Dyslipidemia

Abstract

Background and Objectives: Dyslipidemia refers to the derangements of one or many of the lipoproteins; elevations of total cholesterol (TC), low‑density lipoprotein (LDL) cholesterol and/or triglycerides (TGL), or low levels of high‑density lipoprotein (HDL) cholesterol while elevation of lipoproteins alone is labeled as “hyperlipidemia.” It is a lifestyle disorder of concern today. Statins, fibrates, or a combination of statins with fibrates or niacin have been suggested for their beneficial role in lowering LDL‑cholesterol levels, TGL, and increasing HDL‑cholesterol levels, but with their adverse effects. Based on the positive results of few studies in the past, this protocol is designed to evaluate the effect of individualized homoeopathic medicines along with therapeutic lifestyle changes (TLC) on serum LDL‑cholesterol levels. Materials and Methods: The study will be a multicentric, open‑label, randomized, placebo‑controlled exploratory trial. Patients shall be randomized to Homoeopathy or placebo group of intervention using computerized randomization chart. The period of treatment cum follow‑up shall be for 6 months. TLC shall be given to both the groups. Primary outcome measure will be to evaluate the changes in LDL‑cholesterol levels at 3rd and 6th month from baseline. Discussion: The study shall help in generating evidence about the role of homoeopathic intervention in dyslipidemia and also help in bringing about behavioral change in people about the adoption of a healthy lifestyle.