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

Primary Purpose

Body Weight

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Rhus Coriaria L.(Rhus)
Placebo
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Weight focused on measuring Body weight changes, Medicine, Traditional, Herbal medicine, Rhus, Waist Circumference, Waist-Hip Ratio, Body mass index

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rhus

Placebo

Arm Description

500 mg twice daily after meal for 6 weeks

500 mg twice daily after meal for 6 weeks

Outcomes

Primary Outcome Measures

Body Mass Index

Secondary Outcome Measures

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

Full Information

First Posted
April 26, 2016
Last Updated
August 22, 2018
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02754089
Brief Title
The Effects of Rhus Coriaria L. on Body Weight
Acronym
SomaghWeight
Official Title
The Effects of Rhus Coriaria L. (Rhus or Somagh) on Body Weight
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight
Keywords
Body weight changes, Medicine, Traditional, Herbal medicine, Rhus, Waist Circumference, Waist-Hip Ratio, Body mass index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rhus
Arm Type
Experimental
Arm Description
500 mg twice daily after meal for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
500 mg twice daily after meal for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Rhus Coriaria L.(Rhus)
Other Intervention Name(s)
Somagh
Intervention Description
500 mg twice daily after meals for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
500 mg twice daily after meals for 6 weeks
Primary Outcome Measure Information:
Title
Body Mass Index
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Waist Circumference (cm)
Time Frame
6 weeks
Title
Hip Circumference (cm)
Time Frame
6 weeks
Title
Leptin (ng/ml)
Time Frame
6 weeks
Title
Insulin (mU/l)
Time Frame
6 weeks
Title
Fasting Blood Glucose (mg/dl)
Time Frame
6 weeks
Title
Number of patients with adverse event
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mojtaba Heydari, MD
Organizational Affiliation
Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, IR Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gholamhossein Ranjbar Omrani, MD
Organizational Affiliation
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zahra Hajmohammadi, MD
Organizational Affiliation
Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effects of Rhus Coriaria L. on Body Weight

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