Protocol summary

Summary
The purpose of this research is to evaluate of Kashoos herbal syrup on clinical and paraclinical symptoms of patients affected of fatty liver. The patients with 25 to 50 years old in Liver Clinic of the Firoozgar Hospital who were not affected of other agents of chronic hepatitis including chronic active viral hepatitis, liver metabolic disorders, autoimmune, drug side effects and negative alcohol consumption with positive fatty liver markers (LFT-sonography) for 6 months before study are invited. After giving explanations about the disease and treatment regardless of patients' written consent will be obtained and then the patients enrolled in the study. Initially patients received recommendations in terms of changing lifestyle, physical activity and followed up for three months. If continuous high level of liver enzymes observe in patients, they will enter the second phase. For all patients, a questionnaire including demographic (gender and age), anthropometric (height, weight and BMI), clinical symptoms, bowel symptoms and test results of laboratory and sonography of the liver is completed. With confirmed existence of active fatty liver (high liver enzymes and evidence of sonography), patients are treating with Kashoos syrup for 3 months, ten ml, three meals daily, half an hour before the main meal food. Patients are visited monthly for weight indexes, abdominal circumference (at three points around the navel, above and below the navel), blood pressure (in three positions of lying, sitting and standing) and gastrointestinal, nervous and other symptoms in patients with liver enzymes are measured and recorded. Sonography will be assessed after treatment. Process of response to treatment will follow with sonography (before and after the intervention), clinical and laboratorial parameters (monthly). In the absence of regular follow-up treatment in 2 consecutive visits, volunteers are excluded and a new volunteer enters. With the completion of the 40 persons the study will complete and the data will be presented to one other than those involved in the clinical study for analyze.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014120320197N1
Registration date: 2015-12-14, 1394/09/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-14, 1394/09/23
Registrant information
Name
monirsadat roohollahi
Name of organization / entity
Mashhad University
Country
Iran (Islamic Republic of)
Phone
+98 21 7720 3531
Email address
roohollahi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial for evaluation of Kashoos herbal syrup on clinical and paraclinical symptoms (enzymes and liver sonography) of patients of 25 to 50 years old with Non-Alcoholic Steatohepatitis (NASH)
Public title
Evaluation of Kashoos syrup on clinical and paraclinical symptoms of patients with Non-Alcoholic Steatohepatitis (NASH)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: non presence of CAH; hepatotoxic drug; alcoholic drinks; uncontrolled hypothyroidism; elevation of LFT 6 months before exam; presence of fatty liver in sonography; non using herbal or chemical drugs effective on fatty liver. Exclusion criteria: absence in 2 consecutive visits; demonstration of any unexpected medical side effects (refereed to Liver Clinic of Traditional Medicine).
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Since this intervention by kashoos syrup in the treatment of fatty liver was the first clinical trial and no similar work has been done yet, the study has been done as a pilot study and a formula to determine the sample size was not used.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University
Street address
Quods avenue
City
Tehran
Postal code
Approval date
2015-08-08, 1394/05/17
Ethics committee reference number
IR.TUMS.REC.1394.534

Health conditions studied

1

Description of health condition studied
Nonalcoholic steatohepatitis (NASH)
ICD-10 code
K75.8
ICD-10 code description
One of specified inflammatory liver diseases

Primary outcomes

1

Description
Liver enzymes (ALT, AST)
Timepoint
Monthly
Method of measurement
Laboratory

2

Description
Degree of fatty liver in sonography
Timepoint
Before and after intervention
Method of measurement
Ultrasound

3

Description
Abdominal circumference at three points (around the navel, above and below the navel)
Timepoint
Monthly
Method of measurement
Meter

4

Description
Blood pressure in three positions (lying, sitting and standing)
Timepoint
Monthly
Method of measurement
Mercury sphygmomanometer

Secondary outcomes

empty

Intervention groups

1

Description
Consumption of ten ml of Kashoos herbal syrup three meals daily, half an hour before the main meal food with half cup of boiling water for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Liver Clinic of Firoozgar Hospital
Full name of responsible person
Monirosadat Roohollahi
Street address
Behafarin avenue, Valiasr square
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Traditional Medicine College of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Monirosadat Roohollahi
Street address
East Razi avenue, Tenth of Day square
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Traditional Medicine College of Mashhad 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
Traditional Medicine College of Mashhad University of Medical Sciences
Full name of responsible person
Dr. monirosadat Roohollahi
Position
PHD student of traditional medicine
Other areas of specialty/work
Street address
No 36, Bagheri alley, Hengam avenue, Resalat square.
City
Tehran
Postal code
Phone
+98 21 7720 3531
Fax
Email
roohollahi@razi.tums.ac.ir; asadi.mj@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Traditional Medicine College of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Monirosadat Roohollahi
Position
PHD student of traditional medicine
Other areas of specialty/work
Street address
No 36, Bagheri alley, Hengam avenue, Resalat square.
City
Tehran
Postal code
Phone
+98 21 7720 3531
Fax
Email
roohollahi@razi.tums.ac.ir; asadi.mj@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Traditional Medicine College of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Monirosadat Roohollahi
Position
PHD student of traditional medicine
Other areas of specialty/work
Street address
No 36, Bagheri alley, Hengam avenue, Resalat square.
City
Tehran
Postal code
Phone
+98 21 7720 3531
Fax
Email
roohollahi@razi.tums.ac.ir; asadi.mj@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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