The purpose of this study was to investigate the effect of a traditional medicine on the serum level of liver enzymes in patients with fatty liver disease.The drug is "Dava AL-balgham" that includes the equal proportions of Nigella Sativa ,Zataria Multiflora, Trachyspermum ammi, Pistacia lentiscus which is found in authentic texts of traditional medicine and the official authorities of the drug botanic and new papers on the effects of digestion and eliminating swollen and anti-inflammatory drugs. Anti Atherogenic, have antioxidants. This project is done at the traditional medicine Clinic of the Qom University of Medical Sciences and a gastroenterologist's office. Participants who are satisfied with participation in the ultrasound diagnosis of Fatty Liver Disease and who have been tested for elevated liver enzymes have two A group of 50 patients and matched controls are randomly assigned a code that randomly receives a drug or placebo at two servings per each meal, and at the end of three months, liver enzymes, urea and creatinine levels , Ferritin, weight and ratio of waist circumference to hip and quality of life will be checked.Participants will be given a plan for modifying lifestyle guidelines Until the main treatment of fatty liver disease is not deprived.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017073135415N1
Registration date:2017-09-17, 1396/06/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-17, 1396/06/26
Registrant information
Name
Fatemeh Tooiserkani
Name of organization / entity
Iranian Traditional Medicine of qom
Country
Iran (Islamic Republic of)
Phone
+98 25 3770 7843
Email address
ftooyserkani@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
The financial resources are through the university's research deputy.
Expected recruitment start date
2017-08-21, 1396/05/30
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Dva’-Albalgham ,on serum levels of liver enzymes in patients with NAFLD.
Public title
Assesment of "Dawa al-Blaghm" on liver enzymes in patients with fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Non-Alcohol-Fatty Liver Detection (NAFLD-Based Ultrasonography) 2- Serum Liver Enzyme Levels above Normal 3- Age between 18 and 65 years. 4- Fill in the consent form for participation in the plan.
Exclusion criteria: 1. Patient's lack of consent to continue participating in the project. 2. Any allergy to the drug. 3. The occurrence of any new liver disease that requires the use of specific liver medicines. 4. Pregnancy.
Age
From 17 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
By using the available sampling method, individuals with entry and failure criteria will be included in the study, then treatments will be assigned based on random blocks of four. The blocks and its size and code of cure will be provided by a counselor to a person other than the medical, who measures the response of the patients. Blocks will be randomly selected. According to the estimated number of samples, 25 blocks of volume 4 will be used to select random blocks of dice throwing or Proc PLAN in SAS 9.2 software. Which is based on the treatments provided.
In this way, the choice of treatment type, block selection and sequence of individuals in each block will also be random.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
University of Medical Sciences, Saheli street, Qom, Iran
City
Qom
Postal code
Approval date
2017-07-04, 1396/04/13
Ethics committee reference number
IR.MUQ.REC.1396.44
Health conditions studied
1
Description of health condition studied
Fatty liver desease
ICD-10 code
k76.0
ICD-10 code description
Nonalcoholic fatty liver disease (NAFLD)
Primary outcomes
1
Description
Ast
Timepoint
On arrival, three months after taking a medication or placebo
Method of measurement
U / L, Spectrophotometer
2
Description
Alt
Timepoint
On arrival, three months after taking a medication or placebo
Method of measurement
U / L, Spectrophotometer
3
Description
Alkp
Timepoint
On arrival, three months after taking a medication or placebo
Method of measurement
U / L, Spectrophotometer
Secondary outcomes
1
Description
Crt
Timepoint
At the beginning of the intervention, three months after taking the medication or placebo
Method of measurement
U / L, Spectrophotometer
2
Description
BUN
Timepoint
At the beginning of the intervention, three months after taking the medication or placebo
Method of measurement
U / L, Spectrophotometer
3
Description
PT
Timepoint
At the beginning of the intervention, three months after taking the medication or placebo
Method of measurement
U / L, Spectrophotometer
4
Description
PTT
Timepoint
At the beginning of the intervention, three months after taking the medication or placebo
Method of measurement
U / L, Spectrophotometer
5
Description
INR
Timepoint
At the beginning of the intervention, three months after taking the medication or placebo
Method of measurement
U / L, Spectrophotometer
6
Description
level of quality of life
Timepoint
At the beginning of the intervention, three months after taking the medication or placebo
Method of measurement
Questionnaire 36 questions
7
Description
BMI
Timepoint
At the beginning of the intervention, three months after taking the medication or placebo
Method of measurement
Weight/(height(meter))2 Kg/m2
8
Description
WHR
Timepoint
At the beginning of the intervention, three months after taking the medication or placebo
Method of measurement
Waist to hip circumference Cm/cm
9
Description
Blood presure
Timepoint
At the beginning of the intervention, three months after taking the medication or placebo
Method of measurement
Mercury pressure meter mmHg
Intervention groups
1
Description
The case group receives Dava Al-balgham tablets two pills with each meal, for three months.
Category
Treatment - Drugs
2
Description
The control group receives cellulose tablets in two tablets each serving for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Gastroenterology and Traditional Medicine of Qom University of Medical Sciences, located i
Full name of responsible person
Fateme Tooiserkani
Street address
Faculty of Traditional Iranian Medicine, Third Floor, Faculty of Dentistry, Shahlahi St., Qom.
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qom University of Medical Sciences
Full name of responsible person
Hossein Saghafi
Street address
No. 83, Alley No.4, Alley 1.1, Safashahr sr. Qom.
City
Qom
Grant name
د.2647
Grant code / Reference number
د.2647
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Qom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Traditional Iranian Medicine Qom
Full name of responsible person
Hossein Moradi
Position
Professor of Iranian traditional medicine
Other areas of specialty/work
Street address
Faculty of Traditional Iranian Medicine, Third Floor, Faculty of Dentistry,Saheli St. Qom.Iran.
City
Qom
Postal code
Phone
+98 25 3770 7843
Fax
Email
moradi.medicine@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Medicine, Qom University of Medical Sciences
Full name of responsible person
Hossein moradi
Position
professor of iranian traditional medicin
Other areas of specialty/work
Street address
Faculty of Traditional Iranian Medicine, Third Floor, Faculty of Dentistry,Saheli St. Qom.Iran.
City
Qom
Postal code
Phone
+98 25 3770 7843
Fax
Email
moradi.medicine@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of traditional Medicine, Qom University of Medical Sciences
Full name of responsible person
Fatemeh Tooiserkani
Position
Assistant of iranian traditional medicine
Other areas of specialty/work
Street address
Faculty of Traditional Iranian Medicine, Third Floor, Faculty of Dentistry,Saheli St. Qom.Iran.
City
Qom
Postal code
Phone
+98 25 3770 7843
Fax
Email
ft@muq.ac.ir dr.tooiserkani@gmail.cpm
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)