Clinical Study to Evaluate Antihyperlipidemic Effect of a Classical Unani Antiobesity Formulation
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
1 other identifier
interventional
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 5, 2011
CompletedFirst Posted
Study publicly available on registry
April 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedOctober 21, 2014
October 1, 2014
1 year
April 5, 2011
October 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Total Cholesterol (TC)
six weeks
Low density Lipoprotein (LDL)
six weeks
Triglycerides (TG)
six weeks
High Density Lipoprotein (HDL)
six weeks
Very Low Density Lipoprotein (VLDL)
six weeks
Secondary Outcomes (2)
Waist to Hip ratio
six weeks
Body Mass Index
six weeks
Study Arms (3)
Safoof e Muhazzil in its conventional powder form
EXPERIMENTALsafoof e muhazzil in its conventional powder form 5 gms twice daily given orally
compressed tablet of safoof e muhazzil
EXPERIMENTALcompressed tablet of safoof e muhazzil is given in equivalent dose orally
atorvastatin
ACTIVE COMPARATORatorvastatin 10mg daily as a standard control
Interventions
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
Eligibility Criteria
You may qualify if:
- Age 20 Year(s) To 70 Year(s)
- Gender Both
- participate in Clinical Trial voluntarily.
- Hyperlipidemic
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Majeedia Hospital
New Delhi, National Capital Territory of Delhi, 110062, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Umar Jahangir, MD Scholar
Jamia Hamdard
- PRINCIPAL INVESTIGATOR
Asim Ali Khan, MD
Jamia Hamdard
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
April 5, 2011
First Posted
April 11, 2011
Study Start
May 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
October 21, 2014
Record last verified: 2014-10