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Comparison of the effect of plantago major with placebo on liver enzymes in patients with nonalcoholic fatty liver disease(NAFLD): a double-blind randomized clinical trial

Protocol summary

Study aim
Comparison of the effect of Plantago major with placebo on liver enzymes in patients with nonalcoholic fatty liver disease: a double-blind randomized clinical trial
Design
Clinical trial with placebo,parallel groups,double blind,randomized
Settings and conduct
.In this double-blind clinical trial, the effect of placebo on liver enzymes in non-alcoholic fatty liver patients was evaluated. Patients are randomly divided into two groups of case and control. Liver enzymes (ALT, AST) were measured at baseline and at 6th and 12th week . Both groups received dietary and exercise recommendations alike.Case group recive 2 grams Plantago major per day and the control group receive 2 grams of placebo daily capsules 500 mg. The drug and placebo are coded in similar capsules and in identical packages, with the same color and aroma, and the patient, clinician, and researcher are unaware of how the drug or placebo is coded.
Participants/Inclusion and exclusion criteria
Inclusion critria Non Alcoholic Fatty Liver Disease(NAFLD) pationts with liver enzymes rising (AST>38, ALT>40) and sonographic report grade 1&2 of fatty liver Exclusion critria Age between 12 -80 years old Patient dislike to enter this study Pregnancy & lactation Anti coagulant drugs consumption Thyroid diseases Spleen diseases Cirrhosis, viral hepatitis and obstructive disese of liver Under treatment dyslipidemia Overt D.M Lung diseases History of Alcoholism Consumption of any drug that affects on liver enzymes and liver metabolism such as OCP, corticosteroids, salazins and ext.
Intervention groups
Intervention group: Plantago major seed, 2 grams daily,, Orally, For 12 weeks Control group: Placebo(Sokhari powder) 2 grams daily, , Orally, For 12 weeks
Main outcome variables
Comparison of changes in liver enzymes ََ (ALT, AST) in non-alcoholic fatty liver patients in drug and placebo groups before and after the study.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191006044993N1
Registration date: 2019-11-05, 1398/08/14
Registration timing: registered_while_recruiting

Last update: 2019-11-05, 1398/08/14
Update count: 0
Registration date
2019-11-05, 1398/08/14
Registrant information
Name
Seyedeh ferdos Jazayeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 1303
Email address
sf.jazayeri46@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of plantago major with placebo on liver enzymes in patients with nonalcoholic fatty liver disease(NAFLD): a double-blind randomized clinical trial
Public title
Effect of Plantago major on nonalcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Sono graphic report of Grade 1 and 2 fatty liver Increase in ALT> 40 Increase in AST>38 Ages 12 to 80 years
Exclusion criteria:
The patient's unwillingness to participate in the scheme Pregnancy & lactation Anti coagulant drugs consumption Thyroid diseases Spleen diseases Cirrhosis ,viral hepatitis and obstructive liver disese Treated dyslipidemia Overt Diabetes mellitus Lung diseases Taking any medication that affects liver metabolism and enzymes, including oral contraceptives, corticosteroids, salazines, etc.
Age
From 12 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is used using 4-way blocks and a random number table.Interventions A and B define six blocks of four.Using random numbers, we select and write blocks. Each individual is then assigned to an A or B intervention. For allocation concealment, sealed envelopes are used, so that the individual number is written on the envelope and the treatment group inside the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug and placebo are coded in similar capsules and in identical packages, with the same color and aroma, and the patient, clinician, and researcher are unaware of how the drug or placebo is coded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
No. 167,Mojahedine Eslam Ave.,Behnam Towers
City
Tehran
Province
Tehran
Postal code
1154838346
Approval date
2019-07-20, 1398/04/29
Ethics committee reference number
IR.IUMS.REC.1398.412

Health conditions studied

1

Description of health condition studied
Non Alcoholic Fatty Liver Disease
ICD-10 code
K76-0
ICD-10 code description
Non Alcoholic Fatty Liver Disease

Primary outcomes

1

Description
Comprison of the Plantago major seed with Placebo on ALT enzyme(Alanin trasaminase) in Non Alcoholic Fatty Liver Disease (NAFLD)
Timepoint
Onset, 6th and 12th week of study.(End of study)
Method of measurement
Hitachi 912 instrument

2

Description
Comprison of the Plantago major seed with Placebo on AST enzyme(Aspartate transaminase) in Non Alcoholic Fatty Liver Disease (NAFLD)
Timepoint
Liver enzymes measurement at baseline, 6th and 12th weeks (end of study).
Method of measurement
Hitachi 912 instrument

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:In the intervention group in addition to lifestyle training and in-person follow-up once every 2 weeks, the 500 mg capsule of Plantago major seed twice per day is given, 2 capsules each time, orally for 12 weeks.The seeds of Plantago major are planted and placed in 500 mg capsules in the laboratory of the Faculty of Traditional Medicine.
Category
Treatment - Drugs

2

Description
Control group:In the intervention group in addition to lifestyle training and in-person follow-up once every 2 weeks, the 500 mg capsule of toasted flour twice per day is given, 2 capsules each time, orally for 12 weeks.After preparation, the bread powder was placed in 500 mg capsules in the laboratory of the Faculty of Traditional Medicine.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat-Rasool hospital
Full name of responsible person
Seyede Ferdos Jazayeri
Street address
No.167, Behnam Towers, Mojahedhne Eslam Ave.
City
Tehran
Province
Tehran
Postal code
1154838346
Phone
+98 21 7752 1303
Email
sf.jazayeri46@gmail.com

2

Recruitment center
Name of recruitment center
Behesht Persian Medicin clinic
Full name of responsible person
Seyede Ferdos Jazayeri
Street address
No.167, Behnam Towers, Mojahedhne Eslam Ave.
City
Tehran
Province
Tehran
Postal code
1154838346
Phone
+98 21 7752 1303
Email
sf.jazayeri46@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
ُShahid Hemmat Highway, Iran University of Medical Science
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Seyede Ferdos Jazayeri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 167,Mojahedine Eslam Ave.,Behnam Towers
City
Tehran
Province
Tehran
Postal code
1154838346
Phone
+98 21 7752 1303
Email
sf.jazayeri46@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyede Ferdos Jazayeri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 167,Mojahedine Eslam Ave.,Behnam Towers
City
Tehran
Province
Tehran
Postal code
1154838346
Phone
+98 21 7752 1303
Email
sf.jazayeri46@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyede Ferdos Jazayeri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 167,Mojahedine Eslam Ave.,Behnam Towers
City
Tehran
Province
Tehran
Postal code
1154838346
Phone
+98 21 7752 1303
Email
sf.jazayeri46@gmail.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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