Body WeightSomaghWeightNCT02754089
The Effects of Rhus Coriaria L. on Body Weight
A study testing Rhus Coriaria L.(Rhus) in people with Body Weight, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as "Somagh" on body weight. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight
- What is being tested?
- Rhus Coriaria L.(Rhus)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- May 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) >= 25 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars
About this study
Official title: The Effects of Rhus Coriaria L. (Rhus or Somagh) on Body Weight
The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as "Somagh" on body weight.
Read the 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.
- Conditions
- Body Weight
- Being tested
- Rhus Coriaria L.(Rhus), Placebo
- Keywords
- Body weight changes, Medicine, Traditional, Herbal medicine, Rhus, Waist Circumference, Waist-Hip Ratio, Body mass index
- Medical subject headings
- Body Weight, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhus Coriaria L.(Rhus)Drug
Also called Somagh
500 mg twice daily after meals for 6 weeks
PlaceboDrug
500 mg twice daily after meals for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rhus | Experimental | 500 mg twice daily after meal for 6 weeks Receives: Drug: Rhus Coriaria L.(Rhus) |
| Placebo | Placebo comparator | 500 mg twice daily after meal for 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Measured: 6 weeks
Secondary outcomes (6)
Waist Circumference (cm)
Measured: 6 weeks
Hip Circumference (cm)
Measured: 6 weeks
Leptin (ng/ml)
Measured: 6 weeks
Insulin (mU/l)
Measured: 6 weeks
Fasting Blood Glucose (mg/dl)
Measured: 6 weeks
Number of patients with adverse event
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesbah Shams, MD, Shiraz University of Medical Sciences
- Investigators
- Mojtaba Heydari, MD, Principal investigator, Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, IR IranGholamhossein Ranjbar Omrani, MD, Study chair, Endocrine and Metabolism Research Center, Shiraz University of Medical SciencesZahra Hajmohammadi, MD, Principal investigator, Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754089
- Sponsor's protocol ID
- CT-92-5581
- Acronym
- SomaghWeight
- Status last verified
- Sep 2016
- First submitted
- 26 Apr 2016
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Rhus Coriaria L. (Rhus or Somagh) on Body Weight
- ClinicalTrials.gov ID
- NCT02754089
- Acronym / sponsor ID
- SomaghWeight / CT-92-5581
- Conditions
- Body Weight
- Keywords
- Body weight changes, Medicine, Traditional, Herbal medicine, Rhus, Waist Circumference, Waist-Hip Ratio, Body mass index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhus | Experimental | Drug: Rhus Coriaria L.(Rhus)500 mg twice daily after meal for 6 weeks |
| Placebo | Placebo comparator | Drug: Placebo500 mg twice daily after meal for 6 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) >= 25 kg/m2
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhus Coriaria L.(Rhus)Also: Somagh500 mg twice daily after meals for 6 weeks | Drug | Rhus |
| Placebo500 mg twice daily after meals for 6 weeks | Drug | Placebo |
Primary outcome
Body Mass Index
Time frame: 6 weeks
6 secondary outcomes
Waist Circumference (cm)
Time frame: 6 weeks
Hip Circumference (cm)
Time frame: 6 weeks
Leptin (ng/ml)
Time frame: 6 weeks
Insulin (mU/l)
Time frame: 6 weeks
Fasting Blood Glucose (mg/dl)
Time frame: 6 weeks
Number of patients with adverse event
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mojtaba Heydari, MD principal investigator
Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, IR Iran
Gholamhossein Ranjbar Omrani, MD study chair
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Zahra Hajmohammadi, MD principal investigator
Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhus Coriaria L.(Rhus) in people with Body Weight, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.