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CompletedNCT01332747Updated Oct 21, 2014

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

A Phase 2 interventional study of safoof e muhazzil and compressed tablet of safoof e muhazzil in Hyperlipidemia, sponsored by Jamia Hamdard University. Completed at 1 site in India. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-21.

Sponsored by Jamia Hamdard University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Hyperlipidemia

Keywords

  • TC
  • TG
  • HDL
  • LDL
  • VLDL
03

In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 128 is above the median of 87 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

This is the only study on the registry with Jamia Hamdard University as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (actual)

Study arms

  • 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

  • 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

  • Active comparator
    atorvastatin

    atorvastatin 10mg daily as a standard control

    Drug: Atorvastatin

Interventions

  • Drugsafoof 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

  • Drugcompressed 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

  • DrugAtorvastatin

    atorvastatin 10 mgs once daily

06

What researchers measure

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

07

Study locations

1 site
  • Majeedia Hospital
    New Delhi, Delhi 110062, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01332747
Lead sponsor
Jamia Hamdard University
Responsible party
Umar Jahangir (Lecturer, Jamia Hamdard University) — Principal investigator
First posted
Apr 11, 2011
Start date
May 2010
Primary completion
May 2011
Completion
May 2011
Last update
Oct 21, 2014

Study contacts

Umar Jahangir, MD Scholar
principal investigator · Jamia Hamdard
Asim Ali Khan, MD
principal investigator · Jamia Hamdard

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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