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

Hyperlipidemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332747
• Other study ID #: MD/SM/2008-11
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2011
• Last updated: October 18, 2014
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: October 2014
• Source: Jamia Hamdard University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• safoof e muhazzil
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 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
atorvastatin 10 mgs once daily

Locations

Country	Name	City	State
India	Majeedia Hospital	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Jamia Hamdard University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Cholesterol (TC)		six weeks	No
Primary	Low density Lipoprotein (LDL)		six weeks	No
Primary	Triglycerides (TG)		six weeks	No
Primary	High Density Lipoprotein (HDL)		six weeks	No
Primary	Very Low Density Lipoprotein (VLDL)		six weeks	No
Secondary	Waist to Hip ratio		six weeks	No
Secondary	Body Mass Index		six weeks	No