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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01332747
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : October 21, 2014
Information provided by (Responsible Party):
Umar Jahangir, Jamia Hamdard University

Brief 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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: safoof e muhazzil Drug: compressed tablet of safoof e muhazzil Drug: Atorvastatin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Waist to Hip ratio [ Time Frame: six weeks ]
  2. Body Mass Index [ Time Frame: six weeks ]

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01332747

Majeedia Hospital
New Delhi, Delhi, India, 110062
Sponsors and Collaborators
Jamia Hamdard University
Principal Investigator: Umar Jahangir, MD Scholar Jamia Hamdard
Principal Investigator: Asim Ali Khan, MD Jamia Hamdard

Responsible Party: Umar Jahangir, Lecturer, Jamia Hamdard University Identifier: NCT01332747     History of Changes
Other Study ID Numbers: MD/SM/2008-11
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: October 21, 2014
Last Verified: October 2014

Keywords provided by Umar Jahangir, Jamia Hamdard University:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors