Clinical Study to Evaluate Antihyperlipidemic Effect of a Classical Unani Antiobesity Formulation - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hyperlipidemia	Drug: safoof e muhazzil Drug: compressed tablet of safoof e muhazzil Drug: Atorvastatin	Phase 2

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

Resource links provided by NLM:

Drug Information available for: Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Jamia Hamdard University:

Primary Outcome Measures:

Total Cholesterol (TC) [ Time Frame: six weeks ] [ Designated as safety issue: No ]
Low density Lipoprotein (LDL) [ Time Frame: six weeks ] [ Designated as safety issue: No ]
Triglycerides (TG) [ Time Frame: six weeks ] [ Designated as safety issue: No ]
High Density Lipoprotein (HDL) [ Time Frame: six weeks ] [ Designated as safety issue: No ]
Very Low Density Lipoprotein (VLDL) [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Waist to Hip ratio [ Time Frame: six weeks ] [ Designated as safety issue: No ]
Body Mass Index [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Enrollment:	128
Study Start Date:	May 2010
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Safoof e Muhazzil in its conventional powder form safoof e muhazzil in its conventional powder form 5 gms twice daily given orally	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
Experimental: compressed tablet of safoof e muhazzil compressed tablet of safoof e muhazzil is given in equivalent dose orally	Drug: 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
Active Comparator: atorvastatin atorvastatin 10mg daily as a standard control	Drug: Atorvastatin atorvastatin 10 mgs once daily

Detailed 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.

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332747

Locations

India
Majeedia Hospital
New Delhi, Delhi, India, 110062

Sponsors and Collaborators

Jamia Hamdard University

Investigators

Principal Investigator:	Umar Jahangir, MD Scholar	Jamia Hamdard
Principal Investigator:	Asim Ali Khan, MD	Jamia Hamdard

More Information

No publications provided

Responsible Party:	Dr.Asim Ali Khan MD, Faculty of Medicine (U) Jamia Hamdard
ClinicalTrials.gov Identifier:	NCT01332747 History of Changes
Other Study ID Numbers:	MD/SM/2008-11
Study First Received:	April 5, 2011
Last Updated:	August 16, 2011
Health Authority:	India: Institutional Review Board

Keywords provided by Jamia Hamdard University:

TC
TG
HDL
LDL
VLDL

Additional relevant MeSH terms:

Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hypolipidemic Agents
Atorvastatin
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013