Homeopathic medicines for elevated levels of fat in blood

Phase 2

Recruiting

• Conditions: Hyperlipidemia, unspecified,

• Registration Number: CTRI/2019/11/021930
• Lead Sponsor: National Institute of Homoeopathy

Brief Summary

Disorders of lipoprotein metabolism are collectivelyreferred to as ‘dyslipidemia’. Many patients with dyslipidemia are at increasedrisk for atherosclerotic cardiovascular disease. Recently, in a short review of published homoeopathy research evidences ondyslipidaemia identified four preclinical, three observational studies, and twocase records. There were positive leads in managing patients suffering fromdyslipidaemia. However, more well-designed studies were warranted to generateeffectiveness/efficacy of homeopathy. Inorder to detect the efficacy of individualized homeopathic medicines intreatment of dyslipidemia, this double blind, randomized (1:1),placebo-controlled, two parallel arms, clinical trial will be conducted on 92patients at National Institute of Homoeopathy (NIH). Patients will berandomized to receive either individualized homeopathic medicines in centesimalpotencies, or identical looking placebo. Irrespective of groups, all therandomized patients will be advised for dietary restriction (low saturated fatand high fiber) and regular exercises. The outcome measures - LDLc (primary),VLDLc, HDLc, total cholesterol, triglycerides, and MYMOP-2 (secondary) will beassessed at baseline, and every month, up to 6 months. Comparative analysiswill be carried out to detect group differences. Results will be published inscientific journals.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-08-11
• Study Start: 2019-11-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Newly diagnosed dyslipidemia patients not undergoing any therapy (LDLc level more than 100) 2.
• Age 18-65 years 3.
• Both sexes 4.
• Providing written informed consent.

Exclusion Criteria

• Familial hypertriglyceridemia 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 homeopathic treatment for chronic disease within last 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Low density lipoprotein cholesterol (LDLc)	Baseline, every month, up to 3 months

Secondary Outcome Measures

Name	Time	Method
VLDLc, HDLc, total cholesterol, triglycerides	Baseline, every month, up to 3 months
Measure Yourself Medical Outcome Profile version 2 (MYMOP-2)	Baseline, every month, up to 3 months

Trial Locations

Locations (1)

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

National Institute of Homoeopathy

🇮🇳Kolkata, WEST BENGAL, India

Umesh Kumar

Principal investigator

8100628490

dr.umesh3006@gmail.com