HyperlipidemiaPhase 2NCT01332747
Clinical Study to Evaluate Antihyperlipidemic Effect of a Classical Unani Antiobesity Formulation
A Phase 2 study testing safoof e muhazzil, compressed tablet of safoof e muhazzil and Atorvastatin in people with Hyperlipidemia, run by Jamia Hamdard University at 1 site in India.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- safoof e muhazzil, compressed tablet of safoof e muhazzil and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteIndia
- Study dates
- May 2010to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20 Year(s) To 70 Year(s)
- Gender Both
- participate in Clinical Trial voluntarily.
- Hyperlipidemic
Who cannot join
- Persons below 20 yrs and Above 70 yrs of age
- Pregnancy
- Liver diseases
- Renal diseases
- Diabetes mellitus Type II
- Alcoholic
Show all 9Show fewer
- AIDS
- Thyroid Disease
- Drug intake ? Corticosteroids, Diuretics, Beta-blockers, Oral contraceptives, Cyclosporin, Androgens \& Retinoids
Trial locations and contacts
1 site in 1 country.
India1 site
Majeedia Hospital
New Delhi, National Capital Territory of Delhi, 110062
About this study
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
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.
- Conditions
- Hyperlipidemia
- Being tested
- safoof e muhazzil, compressed tablet of safoof e muhazzil, Atorvastatin
- Keywords
- TC, TG, HDL, LDL, VLDL
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
safoof e muhazzilDrug
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
compressed tablet of safoof e muhazzilDrug
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
AtorvastatinDrug
atorvastatin 10 mgs once daily
| Study group | Role | What they receive |
|---|---|---|
| Safoof e Muhazzil in its conventional powder form | Experimental | safoof e muhazzil in its conventional powder form 5 gms twice daily given orally Receives: Drug: safoof e muhazzil |
| compressed tablet of safoof e muhazzil | Experimental | compressed tablet of safoof e muhazzil is given in equivalent dose orally Receives: Drug: compressed tablet of safoof e muhazzil |
| atorvastatin | Active comparator | atorvastatin 10mg daily as a standard control Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cholesterol (TC)
Measured: six weeks
Low density Lipoprotein (LDL)
Measured: six weeks
Triglycerides (TG)
Measured: six weeks
High Density Lipoprotein (HDL)
Measured: six weeks
Very Low Density Lipoprotein (VLDL)
Measured: six weeks
Secondary outcomes (2)
Waist to Hip ratio
Measured: six weeks
Body Mass Index
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startMay 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jamia Hamdard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umar Jahangir, Jamia Hamdard University
- Investigators
- Umar Jahangir, MD Scholar, Principal investigator, Jamia HamdardAsim Ali Khan, MD, Principal investigator, Jamia Hamdard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332747
- Sponsor's protocol ID
- MD/SM/2008-11
- Status last verified
- Oct 2014
- First submitted
- 5 Apr 2011
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01332747
- Acronym / sponsor ID
- MD/SM/2008-11
- Conditions
- Hyperlipidemia
- Keywords
- TC, TG, HDL, LDL, VLDL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Jamia Hamdard UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Safoof e Muhazzil in its conventional powder form | Experimental | Drug: safoof e muhazzilsafoof e muhazzil in its conventional powder form 5 gms twice daily given orally |
| compressed tablet of safoof e muhazzil | Experimental | Drug: compressed tablet of safoof e muhazzilcompressed tablet of safoof e muhazzil is given in equivalent dose orally |
| atorvastatin | Active comparator | Drug: Atorvastatinatorvastatin 10mg daily as a standard control |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 Year(s) To 70 Year(s)
- Gender Both
- participate in Clinical Trial voluntarily.
- Hyperlipidemic
Key exclusion criteria (9 listed)
- Persons below 20 yrs and Above 70 yrs of age
- Pregnancy
- Liver diseases
- Renal diseases
- Diabetes mellitus Type II
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| safoof e muhazzildrug 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 | Safoof e Muhazzil in its conventional powder form |
| compressed tablet of safoof e muhazzildrug 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 | Drug | compressed tablet of safoof e muhazzil |
| Atorvastatinatorvastatin 10 mgs once daily | Drug | atorvastatin |
Primary outcome
Total Cholesterol (TC)
Time frame: six weeks
Low density Lipoprotein (LDL)
Time frame: six weeks
Triglycerides (TG)
Time frame: six weeks
High Density Lipoprotein (HDL)
Time frame: six weeks
Very Low Density Lipoprotein (VLDL)
Time frame: six weeks
2 secondary outcomes
Waist to Hip ratio
Time frame: six weeks
Body Mass Index
Time frame: six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
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Cardiovascular Diseases, Hypertension
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umar Jahangir, MD Scholar principal investigator
Jamia Hamdard
Asim Ali Khan, MD principal investigator
Jamia Hamdard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing safoof e muhazzil, compressed tablet of safoof e muhazzil and Atorvastatin in people with Hyperlipidemia, run by Jamia Hamdard University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cholesterol (TC) (time frame: six weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2014.