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The effect of Matricaria chamomilla L. on insulin resistance, inflammatory status and other related indices in patients with non-alcoholic fatty liver

Protocol summary

Study aim
To determine the effect of chamomile consumtion on non-alcoholic fatty liver
Design
In this study 44 eligible patients will attend.This double-blind, randomized clinical trial has two groups of intervention and control in parallel.
Settings and conduct
This study is a double blind clinical trial that screening will be done at Fasa University of Medical Sciences Health centers. All patients, physicians and statisticians are unaware of the type of medicine or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1-Diagnosis of fatty liver and steatohepatitis with: A- serum level of Alanine Transaminease (ALT) More than one and a half times the highest normal limit and, the amount of aspartate transaminase (AST) In both sexes is greater than 30 units per liter. B- Diagnosis of fatty liver in liver ultrasound 2-The patient have not to consume some drugs like silybin, ursodeoxycholic acid, Polyene Phosphatidylcholine, vitamin E and other medicines or Medicinal herbs with blood lipid regulation effect and hepatoprotective effect from four weeks bfore entering to the study. exclusion criteria:1-pregnancy and lactation 2-Liver diseases such as Liver failure,autoimmune hepatitis, viral hepatitis B and C (active or inactive), and etc.3-Hypo and hyperthyroidism 4-Any malignancy (treated or not)5-Taking warfarin 6-Taking contraceptives, ouroso-doxycyclic acid, glucocorticoid, statins, probiotics, vitamin E over the past three months 7-Chamomile allergy history
Intervention groups
Patients are divided into two groups of 22.the first group is given chamomile and control group is given placebo.The medication and placebo are 500 mg capsules that will be used two items in fasting morning and two items before bedtime for three months.
Main outcome variables
Degree of fatty liver; Aminotransferase levels; Insulin resistance, lipid profiles

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180903040941N1
Registration date: 2019-06-03, 1398/03/13
Registration timing: prospective

Last update: 2019-06-03, 1398/03/13
Update count: 0
Registration date
2019-06-03, 1398/03/13
Registrant information
Name
sadegh amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3672 3826
Email address
sadeghamiri2877@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-05, 1398/03/15
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Matricaria chamomilla L. on insulin resistance, inflammatory status and other related indices in patients with non-alcoholic fatty liver
Public title
To evaluate effects of Matricaria chamomilla L. on patients with non alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
sign the consent form age between 25-65 years BMI between 22-35 Diagnosis of fatty liver and steatohepatitis with: A- serum level of Alanine Transaminease (ALT) More than one and a half times the highest normal limit(66/5000This means that more than 45 men and women more than or equal to 29 units per liter)Also, the amount of aspartate transaminase (AST) In both sexes is greater than 30 units per liter(According to the latest definition of ALT and abnormal AST in men and women). B- Diagnosis of fatty liver (moderate to high) in liver ultrasound. The patient have not to consume lipid regulating drugs for four weeks The patient have not to consume some drugs like silybin, ursodeoxycholic acid, Polyene Phosphatidylcholine, vitamin E and Medicinal herbs with blood lipid regulation effect and hepatoprotective effect from four weeks bfore entering to the study.
Exclusion criteria:
pregnancy and lactation Liver failure (acute or chronic) Liver diseases such as autoimmune hepatitis, viral hepatitis B and C (active or inactive), Wilson's disease and etc. Hypo and hyperthyroidism Renal failure (creatinine above 1.5 mg / dL) Any malignancy (treated or not) Taking warfarin Addiction and alcohol consumption Taking contraceptives, ouroso-doxycyclic acid, glucocorticoid, statins, probiotics, vitamin E over the past three months Chamomile allergy history
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization Random unit: Individual Randomization Tool: Random Numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researchers will not be aware of the study groups. Drug capsules and placebo capsules are also similar to each other and they are only labeled A and B.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of fasa university of medical science
Street address
Ibn Sina Square, Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2019-02-17, 1397/11/28
Ethics committee reference number
IR.FUMS.REC.1397.150

Health conditions studied

1

Description of health condition studied
non alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Fatty liver grade
Timepoint
Initially and three months later
Method of measurement
Ultrasound

2

Description
Hepatic aminotransferases
Timepoint
Initially and six weeks later and three months later
Method of measurement
Laboratory Kit

3

Description
Fatty liver index(FLI)
Timepoint
Initially and three months later
Method of measurement
Using formula: [e 0.953*loge (triglycerides) + 0.139*BMI + 0.718*loge (ggt) + 0.053*waist circumference - 15.745) / (1 + e 0.953*loge (triglycerides) + 0.139*BMI + 0.718*loge (ggt) + 0.053*waist circumference - 15.745)] × 100

4

Description
Alpha Tumor Necrosis Factor
Timepoint
Initially and three months later
Method of measurement
Laboratory Kit

5

Description
Insulin resistance index
Timepoint
Initially and three months later
Method of measurement
Calculate the HOMA-IR

6

Description
Alkaline phosphatase
Timepoint
initially and three months later
Method of measurement
Laboratory Kit

Secondary outcomes

1

Description
Body mass composition
Timepoint
At the entrance and three months later
Method of measurement
Body mass composition machine

2

Description
Inflammation
Timepoint
At the entrance and three months later
Method of measurement
hs-CRP labratory kit

3

Description
Lipide profile
Timepoint
At the entrance and three months later
Method of measurement
Blood test

Intervention groups

1

Description
Intervention group: A capsule containing 500 mg of chamomile flower powder will be taken four times a day, two fasting morning and two nights before bedtime for three months.
Category
Treatment - Drugs

2

Description
Control group: placebo capsules containing roasted wheat flour plus 50 mg of chamomile powder will be taken four times a day, two fasting morning and two nights before bedtime for three months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali asr hospital
Full name of responsible person
Sadegh amiri
Street address
Ibn sina Square, Vali Asr Hospital
City
Fasa
Province
Fars
Postal code
8668874616
Phone
+98 71 5331 6300
Fax
+98 71 5331 6300
Email
clinicalresearch@fums.com
Web page address
http://vh.fums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mojtaba farjam
Street address
Ibn sina Square, Fasa university of medical science
City
Fasa
Province
Fars
Postal code
8668874616
Phone
+98 71 5331 6300
Email
research@fums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Sadegh amiri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ibn Sina Square, Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
86688-74616
Phone
+98 71 5331 6300
Email
sadeghamiri2877@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr Mohammad hashem hashempur
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Ibn Sina Square, Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
8668874616
Phone
+98 71 5331 6300
Email
hashempur@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Sadegh amiri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ibn sina Square, fasa university of medical science
City
Fasa
Province
Fars
Postal code
8668874616
Phone
+98 71 5331 6300
Email
sadeghamiri2877@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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