Homeopathic treatment of dyslipidaemia

Phase 2/3

Completed

• Conditions: Hyperlipidemia, unspecified,

• Registration Number: CTRI/2018/04/013511
• Lead Sponsor: National Institute of Homoeopathy Ministry of AYUSH Govt of India

Brief Summary

Keeping in view the current scenario of increasing risk of dyslipidemia leading to coronary heart diseases in Indian population and dearth of conclusive evidences in support of homeopathy to treat dyslipidemia, we intended to evaluate the efficacy of empirically selected *Dioscorea villosa* 6CH in comparison with placebo. In this prospective, double-blind, randomized, parallel arm, placebo-controlled trial, 100 patients diagnosed with dyslipidemia were randomized in 1:1 ratio to one of the two interventions – *Dioscorea villosa* 6CH or identical looking placebo in the mutual context of lifestyle modification advices. The outcome measure was the blood lipid profile – triglyceride, total cholesterol (TC), low density lipoprotein cholesterol (LDLc), very low density lipoprotein cholesterol (VLDLc), and high density lipoprotein cholesterol (HDLc), assessed at baseline, and 2 months after intervention. Comparative analysis was conducted on intention-to-treat basis to detect group differences using SPSS. The groups were comparable at baseline. After 2 months of intervention, pre-post comparison showed significant changes in triglyceride, total cholesterol and VLDLc in the verum group; and triglyceride, total cholesterol and LDLc in the placebo group; however, the group differences were non-significant; triglyceride (*P*=0.809), total cholesterol (*P*=0.316), HDLc (*P*=0.430), LDLc (*P*=0.192), and VLDLc (*P*=0.251). Per protocol analysis also revealed similar trends. Thus empirically selected *Dioscorea villosa* 6CH could not produce differentiable effect ct from placebo in treatment of dyslipidemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-30
• Study Completion: 2019-04-26
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Newly diagnosed dyslipidemia patients not undergoing any therapy 2.
• Age 18-65 years 3.
• Both sexes 4.
• Providing written informed consent to participate.

Exclusion Criteria

• Self-reported familial hypertryglyceridaemia 2.
• Patients who are too sick for consultation, unable to read patient information sheet, unwilling to take part or not giving consent to join the study 3.
• Diagnosed cases of systemic diseases, unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure 4.
• Pregnancy and lactation 5.
• Substance abuse and/or dependence 6.
• Self-reported immune-compromised state, and 7.
• Undergoing homoeopathic treatment for chronic disease within last 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood lipid profile - triglyceride, total cholesterol, LDLc, VLDLc, and HDLc	At baseline and after 2 months

Trial Locations

Locations (2)

D.N. De Homoeopathic Medical College & Hospital, Govt of West Bengal; 🇮🇳 Kolkata, WEST BENGAL, India

National Institute of Homoeopathy, Govt. of India; 🇮🇳 Kolkata, WEST BENGAL, India

D.N. De Homoeopathic Medical College & Hospital, Govt of West Bengal

🇮🇳Kolkata, WEST BENGAL, India

Kisor Kumar Naskar

Principal investigator

9433039891

drkisorkumarnaskar@gmail.com