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A randomized, double‐blind, placebo‐controlled trial evaluating the effect of Morus nigra extract on patients with liver cirrhosis

Protocol summary

Study aim
Evaluating the effect of Morus nigra extract on MELD (Model for End‐stage Liver Disease) and Child-Pugh scores in patients with liver cirrhosis
Design
Clinical trial with a control group, parallel, double-blind, randomized, phase 2 on 80 patients (two groups of forty). The patients will be randomized into blocks; the randomization sequence will generate using an online randomization service (www.randomization.com).
Settings and conduct
The patients with liver cirrhosis will be randomized by block randomization method into 2 groups. In the intervention group, patients will receive capsules containing Morus nigra fruit extract (two 500 mg capsules, three times daily) orally for 12 weeks. Subjects in the placebo group will receive two 500 mg capsules orally containing microcrystalline cellulose, three times a day for 12 weeks. In addition to patients, physicians and individuals who perform serum biochemical tests and liver ultrasounds are blinded. Only the person responsible for randomizing and analyzing the results knows about grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with liver cirrhosis awaiting liver transplantation. Exclusion criteria: Hepatocellular carcinoma or other malignancy, history of liver transplantation, alcoholic drink, variceal bleeding, portal vein thrombosis, and pregnancy.
Intervention groups
The treatment group will receive capsules containing Morus nigra extract (two 500 mg capsules, three times daily) for 12 weeks. Subjects in the placebo group will receive capsules containing microcrystalline cellulose (Avicel) with the same schedule.
Main outcome variables
MELD index (Model for End‐stage Liver Disease)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140301016776N3
Registration date: 2021-06-15, 1400/03/25
Registration timing: prospective

Last update: 2021-06-15, 1400/03/25
Update count: 0
Registration date
2021-06-15, 1400/03/25
Registrant information
Name
Ahmad Ghorbani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1800 2262
Email address
ghorbania@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized, double‐blind, placebo‐controlled trial evaluating the effect of Morus nigra extract on patients with liver cirrhosis
Public title
The effect of Morus nigra extract on patients with liver cirrhosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with liver cirrhosis awaiting liver transplantation
Exclusion criteria:
Hepatocellular carcinoma or other malignancy History of liver transplantation Alcoholic drink Variceal bleeding Portal vein thrombosis Pregnancy
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In order to balance the number of patients in the two groups (A and B), the block randomization method will be used. After confirming the inclusion criteria and obtaining consent, patients are randomized by the research assistant based on blocks with size 4 or 6 . According to the sample size of 80 participants, 8 blocks with size 4 from AABB, ABAB, ABBA, BABA, BBAA, BAAB and 8 with size 6 from AAABBB, BBBAAA, BAAABB, BAABBA, BBAAAB, ABBABA, BABBAA, ABBAAB, BBABAA, ........ are selected using a random number table. The sealed envelope will be used for randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Packages containing drug and placebo capsules are marked A and B. After randomization of patients by the research assistant, the capsules are provided to the participants by the same assistant. Two groups of participants (intervention patients and control patients) and researchers evaluating patients (serum biochemical factors and liver ultrasound) are not aware of grouping.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Qoreyshi building - Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-01-27, 1399/11/08
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.817

Health conditions studied

1

Description of health condition studied
Liver cirrhosis
ICD-10 code
K74
ICD-10 code description
Fibrosis and cirrhosis of liver

Primary outcomes

1

Description
MELD index.
Timepoint
Before intervention and end of the study.
Method of measurement
The MELD index is determined by total bilirubin, serum creatinine, and INR (9.57 Ln(Creat) + 3.78 Ln(bili) + 11.2 Ln(INR) + 6.43).

Secondary outcomes

1

Description
Child-Pugh
Timepoint
before intervention and at the end of study
Method of measurement
This index is calculated based on total bilirubin, albumin, INR, ascites and encephalopathy.

2

Description
Patient survival
Timepoint
One year after enrollment.
Method of measurement
Record the number of patient deaths

3

Description
Liver enzymes
Timepoint
Before intervention and at the end of study
Method of measurement
Fasting blood test

Intervention groups

1

Description
Intervention group: In this group, patients will receive capsules containing Morus nigra fruit extract (two 500 mg capsules, three times daily) orally for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: Subjects in the placebo group will receive capsules containing microcrystalline cellulose (two 500 mg capsules, three times daily) orally for 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Educational Research and Treartment Center
Full name of responsible person
Dr. Mitra Ahadi
Street address
Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Qoreyshi building - Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad Ghorbani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Department of Pharmacology, Faculty of Medicine, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2278
Fax
+98 51 1882 8567
Email
ghorbania@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad Ghorbani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Department of Pharmacology, Faculty of Medicine,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2278
Fax
+98 51 1882 8567
Email
ghorbania@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad Ghorbani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Department of Pharmacology, Faculty of Medicine,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2278
Fax
+98 51 1882 8567
Email
ghorbania@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study data including results related to primary and secondary outcomes after statistical analysis can be shared.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
Available for people working in academic institutions
Under which criteria data/document could be used
Sharing of study data is subject to permission of Mashhad University of Medical Sciences.
From where data/document is obtainable
Applicants can contact the principle Investigator via email.
What processes are involved for a request to access data/document
Sharing of study data is subject to permission of Mashhad University of Medical Sciences.
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