The effect of Rheum Palmatum syrup (traditional medicine product) with diet and exercise in comparison with diet and exercise alone on liver enzymes in patients with non-alcoholic fatty liver (NAFLD)
Determining the effect of Rheum Palmatum syrup (traditional medicine product) with diet and exercise in comparison with diet and exercise alone on liver enzymes in patients with non-alcoholic fatty liver
Design
Two arm parallel groups randomized controlled trial on 50 patients, random allocation software was used for randomization.
Settings and conduct
Fifty patients referred to the Liver and Gastroenterology Clinic of Imam Khomeini Hospital who suffer from non-alcoholic fatty liver are randomly assigned to one of the two intervention or control groups. At the end of the treatment period, the drug will be discontinued and liver tests will be repeated and recorded. The patients will be followed up for another three months without receiving medication, and at the end of three months, liver and sono tests will be repeated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 60 years and also fatty liver disease based on high liver enzymes with the diagnosis of a gastroenterologist and exclusion criteria includes: type 1 and type 2 diabetes require medication, positive serology for viral hepatitis B and C, Liver and kidney disease, Blood pressure-requiring medication (BP>130/85 mmhg), Liver cirrhosis, Pregnancy and lactation, Hyperlipidemia requiring medication TG> 150 mg / dl, Taking drugs such as valproate, amiodarone, methotrexate, tamoxifen, corticosteroids, hypothyroidism require medication and active malignancy in the body.
Intervention groups
Intervention group: Receiving Rheum Palmatum syrup along with receiving diet modification training and exercise
Control group: receive diet modification and exercise training
Main outcome variables
ALT level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211019052813N1
Registration date:2021-11-21, 1400/08/30
Registration timing:prospective
Last update:2021-11-21, 1400/08/30
Update count:0
Registration date
2021-11-21, 1400/08/30
Registrant information
Name
Mina Mohebbi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3358 7989
Email address
dr.m_mohebi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rheum Palmatum syrup (traditional medicine product) with diet and exercise in comparison with diet and exercise alone on liver enzymes in patients with non-alcoholic fatty liver (NAFLD)
Public title
Rheum Palmatum syrup and NAFLD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 60 years
Fatty liver disease based on high liver enzymes
Exclusion criteria:
Type 1 and type 2 diabetes (requires medication)
Positive serology of viral hepatitis B and C (anti-HCV or HBsAg positive)
Liver and kidney disease
Blood pressure-requiring medication (BP> 85/85 mmhg)
Liver cirrhosis
Pregnancy and lactation
Hyperlipidemia (requires medication TG> 150mg / dl)
Wilson and hemochromatosis
Autoimmune hepatitis
Taking drugs such as valproate, amiodarone, methotrexate, tamoxifen, corticosteroids
Hypothyroidism (requires medication)
Active malignancy in the body
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected according to the inclusion criteria and then randomly assigned to the experimental and control groups according to the random sequence obtained through random allocation software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St, Keshavarz Blvd.