- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02754089
The Effects of Rhus Coriaria L. on Body Weight (SomaghWeight)
The Effects of Rhus Coriaria L. (Rhus or Somagh) on Body Weight
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rhus coriaria L.(Rhus) is a well-known spice widely consumed in the world which has also been utilized extensively for medicinal purposes. The antioxidant components of this plant made it a favorable target for laboratory and animal studies in different conditions such as oxidative stress cytotoxicity, diabetes and hyperlipidemia. Rhus (Somagh) is found in temperate and tropical regions worldwide, often growing in areas of marginal agricultural capacity. Rhus is used as an herbal remedy in traditional medicine because of its assumed analgesic, antidiarrheic, antiseptic, anorexic and antihyperglycemic properties. The fruits of Rhus contain flavonols, phenolic acids, hydrolysable tannins, anthocyans and organic acids such as malice, citric and tartaric acids. Some studies have shown that polyphenols could have beneficial effects on cardiovascular disease and cancer and could be regarded as bioactive compounds with a high potential health-promoting capacity. Phenolic compounds inhibit lipid peroxidation, scavenge the superoxide anion and hydroxyl radical, and enhance the activities of detoxifying enzymes.
The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as Somagh on body weight.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Fars
-
Shiraz, Fars, Iran, Islamic Republic of
- Shahid Motahhari Clinic, Shiraz University of Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body mass index (BMI) >= 25 kg/m2
Exclusion Criteria:
- Diabetes mellitus
- Hypo. or hyperthyroidism
- Any systemic illnesses e.g. liver cirrhosis, acute or chronic renal failure, heart failure
- Use of drugs: Weight lowering agents, glucocorticoids, Oral contraceptive pills.
- Pregnancy
- History of allergic reaction to Somagh
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
500 mg twice daily after meal for 6 weeks
|
500 mg twice daily after meals for 6 weeks
|
Experimental: Rhus
500 mg twice daily after meal for 6 weeks
|
500 mg twice daily after meals for 6 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body Mass Index
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Waist Circumference (cm)
Time Frame: 6 weeks
|
6 weeks
|
Hip Circumference (cm)
Time Frame: 6 weeks
|
6 weeks
|
Leptin (ng/ml)
Time Frame: 6 weeks
|
6 weeks
|
Insulin (mU/l)
Time Frame: 6 weeks
|
6 weeks
|
Fasting Blood Glucose (mg/dl)
Time Frame: 6 weeks
|
6 weeks
|
Number of patients with adverse event
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Gholamhossein Ranjbar Omrani, MD, Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
- Principal Investigator: Mojtaba Heydari, MD, Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, IR Iran
- Principal Investigator: Zahra Hajmohammadi, MD, Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT-92-5581
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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