Effect of a diet based on the principles of traditional medicine on the clinical symptoms and Para clinical in the Class A and B patients with cirrhosis admitted to Imam Hussein and Taleghani hospital in 92-93 years
Aims: the goal of the project was to determine the effect of a diet based on the principles of Iranian Traditional Medicine Clinical and Para clinical patients with liver cirrhosis classes A and B referred to Imam Hussein and Taleghani hospital in 92-93 years.
Design: this studies a randomized controlled clinical trial, Phase 2 clinical trial. Setting and conduct: they are divided into two groups: the experimental group and the control group. The experimental group received diet plan and the control group received instructions to maintain health based on the principles of Traditional Medicine. Number of cases is 80 and during the 3-month study.
Including criteria: Class A and B cirrhotic patients diagnosed with ultrasound in age from 20-70 years and in the past two weeks have not been ill and acute complications and diabetes, Hepato cellular carcinoma, hepatic encephalopathy, and chronic renal failure are not included.
Excluding criteria: Failure to follow instructions for two weeks and Complications that lead to hospitalization and Intolerance Diet Plan whatever reason exclusion is due.
The main outcome variables: tests: albumin, bilirubin, INR, serum creatinine and LFT before and after the designs are evaluated, nausea and vomiting, muscle spasms are assessed with questionnaires and malnutrition with BMI.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122415864N1
Registration date:2014-02-06, 1392/11/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-02-06, 1392/11/17
Registrant information
Name
Jamileh Mahdavi Jafari
Name of organization / entity
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center, Shahid Behe
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3522
Email address
jmahdavi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a diet based on the principles of traditional medicine on the clinical symptoms and Para clinical in the Class A and B patients with cirrhosis admitted to Imam Hussein and Taleghani hospital in 92-93 years
Public title
Effect of diet based on the principles of traditional medicine in cirrhosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Class A and B cirrhosis diagnosed by ultrasonography; Age 20-70; Informed consent; Lack of complications of acute illness within 2 weeks; Not get out of the routine treatment protocols over the past 2 weeks; Non- hepato cellular carcinoma; Lack of hepatic encephalopathy; Lack of chronic renal failure; Non- diabetic.
Exclusion criteria were: Failure to follow instructions for two weeks; Complications leading to hospitalization; Intolerance Diet Plan whatever reason.
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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 Shahid Beheshti University of Medical Sciences, Office of Research Affairs, Depu
Street address
Parvaneh St., Yemen St., Shahid Chamran Highway, next to Taleghani Hospital, Sixth Floor, College Staff Building Number Two, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Approval date
2013-12-29, 1392/10/08
Ethics committee reference number
144
Health conditions studied
1
Description of health condition studied
cirrhosis of liver
ICD-10 code
K74.6
ICD-10 code description
Other and unspecified cirrhosis of liver
Primary outcomes
1
Description
Body Mass Index
Timepoint
Before intervention & week 12 after intervention
Method of measurement
Balance & Meter
2
Description
Muscle spasm
Timepoint
Weeks 4, 8 &12 from start of intervention
Method of measurement
Question from patient
3
Description
Nausea and vomiting
Timepoint
Weeks 4, 8 &12 from start of intervention
Method of measurement
Question from patient
4
Description
Serum Albumin
Timepoint
Before intervention & week 12 after intervention
Method of measurement
Electrophoresis
5
Description
Bilirubin Total
Timepoint
Before intervention & week 12 after intervention
Method of measurement
Spectrophotometer
6
Description
International normalized ratio
Timepoint
Before intervention & week 12 after intervention
Method of measurement
Spectrophotometer
7
Description
Aspartate aminotransferase
Timepoint
Before intervention & week 12 after intervention
Method of measurement
Spectrophotometer
8
Description
Alanine transaminase
Timepoint
Before intervention & week 12 after intervention
Method of measurement
Spectrophotometer
9
Description
Alkaline phosphatase
Timepoint
Before intervention & week 12 after intervention
Method of measurement
Spectrophotometer
10
Description
Serum Creatinine
Timepoint
Before intervention & week 12 after intervention
Method of measurement
Spectrophotometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: diet for breakfast, lunch, dinner, based on the principles of Traditional Medicine with commands to protect the health based on the principles of Traditional Medicine in the regulation of the habits of sleep and food
Category
Lifestyle
2
Description
Control group: daily diet with commands to protect the health based on the principles of Traditional Medicine in the regulation of the habits of sleep and food
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Hospital
Full name of responsible person
Mohammad Javad Ehsani Ardekani M.D
Street address
Shahid Madani (north side) St., before the Imam Hussain Square, Imam Hossein Hospital