NCT02754089

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 23, 2018

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

April 26, 2016

Last Update Submit

August 22, 2018

Conditions

Body Weight

Keywords

Body weight changesMedicine, TraditionalHerbal medicineRhusWaist CircumferenceWaist-Hip RatioBody mass index

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    6 weeks

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Rhus

EXPERIMENTAL

500 mg twice daily after meal for 6 weeks

Drug: Rhus Coriaria L.(Rhus)

Placebo

PLACEBO COMPARATOR

500 mg twice daily after meal for 6 weeks

Drug: Placebo

Interventions

Rhus Coriaria L.(Rhus)DRUG

500 mg twice daily after meals for 6 weeks

Also known as: Somagh
Rhus
PlaceboDRUG

500 mg twice daily after meals for 6 weeks

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) \>= 25 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Body WeightBody Weight Changes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mojtaba Heydari, MD

    Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, IR Iran

    PRINCIPAL INVESTIGATOR

  • Gholamhossein Ranjbar Omrani, MD

    Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

    STUDY CHAIR

  • Zahra Hajmohammadi, MD

    Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Internal Medicine & Endocrinology

Study Record Dates

First Submitted

April 26, 2016

First Posted

April 28, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

August 23, 2018

Record last verified: 2016-09

Locations

IR(1)