SomaghWeight: The Effects of Rhus Coriaria L. on Body Weight

Sponsor

Shiraz University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02754089

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as "Somagh" on body weight.

Condition or Disease	Intervention/Treatment	Phase
Body Weight	Drug: Rhus Coriaria L.(Rhus) Drug: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effects of Rhus Coriaria L. (Rhus or Somagh) on Body Weight

Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rhus 500 mg twice daily after meal for 6 weeks	Drug: Rhus Coriaria L.(Rhus) 500 mg twice daily after meals for 6 weeks Other Names: Somagh
Placebo Comparator: Placebo 500 mg twice daily after meal for 6 weeks	Drug: Placebo 500 mg twice daily after meals for 6 weeks

Arm

Intervention/Treatment

Experimental: Rhus

500 mg twice daily after meal for 6 weeks

Drug: Rhus Coriaria L.(Rhus)

500 mg twice daily after meals for 6 weeks

Other Names:

Somagh

Placebo Comparator: Placebo

500 mg twice daily after meal for 6 weeks

Drug: Placebo

500 mg twice daily after meals for 6 weeks

Outcome Measures

Primary Outcome Measures

Body Mass Index [6 weeks]

Secondary Outcome Measures

Waist Circumference (cm) [6 weeks]
Hip Circumference (cm) [6 weeks]
Leptin (ng/ml) [6 weeks]
Insulin (mU/l) [6 weeks]
Fasting Blood Glucose (mg/dl) [6 weeks]
Number of patients with adverse event [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shahid Motahhari Clinic, Shiraz University of Medical Sciences	Shiraz	Fars	Iran, Islamic Republic of

Sponsors and Collaborators

Shiraz University of Medical Sciences

Investigators

Principal Investigator: Mojtaba Heydari, MD, Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, IR Iran
Study Chair: Gholamhossein Ranjbar Omrani, MD, Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Principal Investigator: Zahra Hajmohammadi, MD, Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Iran