Determine the effect of Sumac on serum lipids, uric acid and BMI of hemodialysis patients
Design
A clinical trial with control group was performed on 120 patients undergoing hemodialysis, stratified blocking in a randomized way in three parallel groups, in a phase three clinical trials
Settings and conduct
After obtaining permission from the hospital authorities, by presenting a complete letter of introduction to the patients, based on the criteria for entry and no entry in the dialysis unit of the Shohadaye Ashayer Hospital. After obtaining informed consent, the pre-intervention data were collected in three groups And then the intervention will be done. So that the two groups will receive 2 and 3 grams of Sumac powder and the third group will receive the placebo powder wheat. Common treatments will not be removed. A dietary recall questionnaire and physical activity form are completed before and after the study. The primary and secondary outcome variables are measured and recorded before, sixth and twelfth weeks.
Participants/Inclusion and exclusion criteria
Conditions of entry:
The desire to participate in research with informed consent
Cure for chronic renal failure according to a doctor's diagnosisy
Conditions of No entry::
Any sensitivity and allergy to Sumac and their products
Mental disorders
Intervention groups
The two groups are as 2 grams and 3 grams of Sumac, and one as a placebo or control group (wheat flour).
Main outcome variables
Serum levels of lipids (primary outcome) and uric acid and body mass index (secondary outcome) are measured and recorded before the intervention, sixth and twelfth weeks after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180407039214N1
Registration date:2018-06-19, 1397/03/29
Registration timing:prospective
Last update:2018-06-19, 1397/03/29
Update count:0
Registration date
2018-06-19, 1397/03/29
Registrant information
Name
Fereshteh Allahnouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3522 8879
Email address
f.alahnoori95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rhus Coriaria(Sumac) on serum levels of lipids, uric acid and Body Mass Index(BMI) in patients under hemodialysis
Public title
The effect of Rhus Coriaria on serum levels of lipids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age range is 70-35 years
Cure for chronic renal failure according to a doctor's diagnosis
Start at least three months hemodialysis
Do three hemodialysis per week
Nephrologist confirmation for patient entry to study
Access to the patient 3 months after entering the study
The desire to participate in research with informed consent
Exclusion criteria:
Any sensitivity and allergy to Sumac and their products
Mental disorders
pain and acute illness
Excessive weight loss and obesity 40 ≥ BMI ≥ 19
Follow Weight Loss Diets Under Dieticians
History of obstructive and inflammatory diseases of the stomach and intestines
Severe constipation
Pregnancy and lactation
Smoking and drinking alcohol
Cold
Getting more than one lipid-lowering drug (Jim Fiberozyl, etc.)
Get a Uric acid-lowering drug
Having regular and intense activity
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified blocks are randomly divided into three groups, while gender, age, and base lipids are matched.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Deputy of Research and Technology of Lorestan University of Medical Sciences, Kamalvand, 5 km Khorramabad - Boroujerd Road
City
KhorramAbad
Province
Lorestan
Postal code
381251698
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.LUMS.REC.1396.399
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
Z49.0
ICD-10 code description
Preparatory care for renal dialysis
Primary outcomes
1
Description
serum levels of lipids
Timepoint
Before the intervention, 6 weeks after the intervention and 12 weeks after the intervention
Method of measurement
Laboratory tests
Secondary outcomes
1
Description
uric acid
Timepoint
Before the intervention, 6 weeks after the intervention and 12 weeks after the intervention
Method of measurement
Laboratory tests
2
Description
Body Mass Index
Timepoint
Before the intervention, 6 weeks after the intervention and 12 weeks after the intervention