Skip to main content
OpenTrials
Completed

NCT Number: NCT01332747

Clinical Study to Evaluate Antihyperlipidemic Effect of a Classical Unani Antiobesity Formulation

The purpose of this clinical trial is to study the comparative effect of a classical unani antiobesity drug safoof-e-muhazzil on hyperlipidemia in its classical powder form and in compressed tablet form against a standard control.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Majeedia Hospital

New Delhi, National Capital Territory of Delhi, 110062, India

About this study

  • The largest proportion of cardiovascular diseases is represented by Coronary artery disease(CAD), cerebral and peripheral vascular diseases. During the past decades efficacious strategies have been developed for prevention of these diseases. These strategies involve general lifestyle changes, which include, healthy diet, optimal weight, physical activity, moderate or no alcohol consumption, and smoking cessation, treatment of high blood pressure, control of diabetes mellitus and in particular, treatment of hyperlipidemia.
  • Major clinical trials carried out, have shown a clear benefit of low density lipoprotein-cholesterol(LDL-C) reduction in terms of both CAD events and total mortality. A similar reduction in the relative risk of coronary events has been documented in patients with and without clinically evident CAD and in patients with mild or severe hyperlipidemia.
  • Hyperlipidemia can be primary which is gene related causing defects in the synthesis of lipoprotein degradation. The other type of hyperlipidemia is secondary which is subsequent to related metabolic abnormalities.
  • Although several Unani physicians have mentioned considerable details about fats in blood but it is observed that Hyperlipidemia has not been mentioned per se in the classical Unani literature.
  • A condition that resembles hyperlipidemia in various aspects like etiology, clinical features and complications has been described as obesity in the classical Unani literature and mentions related methods for managing such disorders including regimens and drugs (for reducing weight) are also observed in such references.
  • Unani physicians have bracketed obesity under cold derangement of temperament.
  • Unani physicians have emphasized the effect of Safoof-e-Muhazzil as the main weight loss drug.
  • Furthermore, Many of the drugs present in Safoof-e-Muhazzil including Lac which itself is a constituent of Safoof-e-Muhazzil have been attributed by Unani physicians to have de obstruent, desiccant, and softening and relaxant effect on vessel walls properties which further supports our hypothesis. These properties are also in cohesion with our hypothesis and perhaps these drugs may have scraping effect on atherosclerotic vessel walls.
  • Lipids are metabolized mainly in the liver and it is the error of the liver or the weakness of the liver that these lipids go unchecked into the blood stream.
  • Since most of constituents of Safoof-e-Muhazzil including Lac have been attributed to be liver strengthening agents, hence, due to their corrective effect on liver may help correcting raised lipid levels in the blood.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 20 Year(s) To 70 Year(s)
  • Gender Both
  • participate in Clinical Trial voluntarily.
  • Hyperlipidemic

Exclusion criteria

  • Persons below 20 yrs and Above 70 yrs of age
  • Pregnancy
  • Liver diseases
  • Renal diseases
  • Diabetes mellitus Type II
  • Alcoholic
  • AIDS
  • Thyroid Disease
  • Drug intake ? Corticosteroids, Diuretics, Beta-blockers, Oral contraceptives, Cyclosporin, Androgens & Retinoids

Treatment and study plan

safoof e muhazzil

Drug

drug is composed of 5 herbal(Carum Carvi,Trachyspermum copticum,Foeniculum Vulgare,Origanum Vulgare,Ruta Graveolens) 1 animal origin (Lac)and 1 mineral origin (Borax) ingredients.

to be given in a dosage of 5 gms twice daily

compressed tablet of safoof e muhazzil

Drug

drug is composed of 5 herbal(Carum Carvi,Trachyspermum copticum,Foeniculum Vulgare,Origanum Vulgare,Ruta Graveolens) 1 animal origin (Lac)and 1 mineral origin (Borax) ingredients.

compressed into tablets of 1 gm each+ binders qs. dose is 5 tablets twice daily

atorvastatin

Drug

atorvastatin 10 mgs once daily

Primary outcomes

  1. Total Cholesterol (TC)

    Time frame: six weeks

  2. Low density Lipoprotein (LDL)

    Time frame: six weeks

  3. Triglycerides (TG)

    Time frame: six weeks

  4. High Density Lipoprotein (HDL)

    Time frame: six weeks

  5. Very Low Density Lipoprotein (VLDL)

    Time frame: six weeks

Secondary outcomes

  1. Waist to Hip ratio

    Time frame: six weeks

  2. Body Mass Index

    Time frame: six weeks

Sponsors and collaborators

Lead sponsor

Jamia Hamdard University

Other

Registry information

Official study title

Clinical Study on Hyperlipidemia and Comparative Evaluation of Efficacy of a Compound Unani Formulation (Safoof e Muhazzil) and Compressed Tablet of Safoof e Muhazzil in Its Management

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 11, 2011
Registry last updated
Oct 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.