NCT02891031

Brief Summary

The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as "Somagh" on serum uric acid levels.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 31, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
2.7 years until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

August 31, 2016

Last Update Submit

April 4, 2019

Conditions

Hyperuricemia

Keywords

RhusMedicine, TraditionalHerbal medicineUric acid

Outcome Measures

Primary Outcomes (1)

  • serum uric acid levels

    6 weeks

Secondary Outcomes (1)

  • Number of patients with adverse events.

    6 weeks

Study Arms (2)

Rhus (Somagh)

ACTIVE COMPARATOR

500 mg twice daily after meal for 6 weeks

Drug: Rhus (Somagh)

Placebo

PLACEBO COMPARATOR

500 mg twice daily after meal for 6 weeks

Drug: Placebo

Interventions

Rhus (Somagh)DRUG

500 mg twice daily after meal for 6 weeks

Also known as: Somagh
Rhus (Somagh)
PlaceboDRUG

500 mg twice daily after meal for 6 weeks

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy individuals

You may not qualify if:

  • Serum uric acid levels that need medical treatment
  • Gout
  • Diabetes mellitus
  • Hypo. or hyperthyroidism
  • Any systemic illnesses e.g. liver cirrhosis, acute or chronic renal failure, heart failure
  • Use of drugs: Uric acid lowering agents
  • Pregnancy
  • Lactation
  • 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

Hyperuricemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gholamhossein Ranjbar Omrani, MD

    Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Seiyed Mohammad Hosseini-Saadi, MD

    Department of Internal Medicine, Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mesbah Shams, MD

CONTACT

+98-71-36474316shams@sums.ac.ir

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 and Endocrinology

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 7, 2016

Study Start

June 1, 2019

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)