Clinical Study to Evaluate Antihyperlipidemic Effect of a Classical Unani Antiobesity Formulation
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): safoof e muhazzil; compressed tablet of safoof e muhazzil; Atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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; 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 10 mgs once daily
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TC; TG; HDL; LDL; VLDL