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Evaluation of the effectiveness of Curcumin in the improving patients with autoimmune hepatitis

Protocol summary

Study aim
Evaluation of the effectiveness of Curcumin in the improving patients with autoimmune hepatitis (HIA) referred to Imam Ali research hospital and Edaalat clinic of Zahedan
Design
A randomized clinical trial with placebo and treatment with Curcumin groups, 2 Blinded, including 68 patients, randomized, The rand function of Excel software was used for randomization.
Settings and conduct
This study will be performed on 68 patients with HIA referred to Imam Ali Research Hospital and Edaalat Clinic of Zahedan city. Patients in the Curcumin treatment group will receive the standard HIA treatment protocol with 500 mg per day of curcumin for 2 months and in the placebo group will receive the standard HIA treatment protocol with placebo for 2 months (with the same duration). Finally, laboratory tests (CBC, Bill, Cholesterol, ANA, ALT, ALP, AST and IgG) will be measured in 2 time periods before curcumin consumption and 2 months after curcumin consumption to determine the effect of Curcumin.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range from 18 to 50 years, Patients with HIA based on diagnostic criteria (abnormalities of AST and ALT levels, hypergammaglobulinemia and increased serum IgG levels), positive serological findings (SMA, ANA and anti-LKM1). Exclusion criteria: Primary Biliary Cirrhosis, Primary Sclerosing Cholangitis, Wilson's or Hemochromatosis, Liver Cirrhosis, Fulminant Liver Failure, history of drug treatment with hepatotoxicity
Intervention groups
Placebo group: patients with standard HIA treatment protocol with placebo for 2 months, Experimental group: patients with standard HIA treatment protocol with 500 mg/day curcumin for 2 months
Main outcome variables
Laboratory tests complete blood count (CBC), Bilirubin (Bill), antinuclear antibody (ANA), alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), Immunoglobulin G (IgG)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221112056476N1
Registration date: 2024-03-06, 1402/12/16
Registration timing: prospective

Last update: 2024-03-06, 1402/12/16
Update count: 0
Registration date
2024-03-06, 1402/12/16
Registrant information
Name
Samira Shahraki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 2040
Email address
shahrakis@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-10, 1402/12/20
Expected recruitment end date
2025-02-08, 1403/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Curcumin in the improving patients with autoimmune hepatitis
Public title
Evaluation of the effectiveness of Curcumin in the improving patients with autoimmune hepatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 18 to 50 years Suffering from autoimmune hepatitis based on diagnostic criteria (abnormalities of AST and ALT levels, hypergammaglobulinemia and increased serum IgG levels), positive serological findings (SMA, ANA and anti-LKM1) and histological findings and confirmed by an adult gastroenterologist
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
People have been blinded: Participant and Data analyzer Curcumin and placebo are completely similar in shape, color and administration method
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
University 25, University Street, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
۹۸۱۶۷۴۳۱۱۱
Approval date
2023-06-18, 1402/03/28
Ethics committee reference number
IR.ZAUMS.REC.1402.133

Health conditions studied

1

Description of health condition studied
Autoimmune hepatitis
ICD-10 code
K75.4
ICD-10 code description
Autoimmune hepatitis

Primary outcomes

1

Description
Complete Blood Count (CBC)
Timepoint
Before curcumin consumption and 2 months after curcumin consumption
Method of measurement
Blood cells count

2

Description
Bilirubin (Bill)
Timepoint
Before curcumin consumption and 2 months after curcumin consumption
Method of measurement
Based on laboratory tests

3

Description
Antinuclear antibody
Timepoint
Before curcumin consumption and 2 months after curcumin consumption
Method of measurement
ELISA

4

Description
Alanine Transaminase (ALT)
Timepoint
Before curcumin consumption and 2 months after curcumin consumption
Method of measurement
Based on laboratory tests

5

Description
Alkaline Phosphatase (ALP)
Timepoint
Before curcumin consumption and 2 months after curcumin consumption
Method of measurement
Based on laboratory tests

6

Description
Aspartate Aminotransferase (AST)
Timepoint
Before curcumin consumption and 2 months after curcumin consumption
Method of measurement
Based on laboratory tests

7

Description
Immunoglobulin G (IgG)
Timepoint
Before curcumin consumption and 2 months after curcumin consumption
Method of measurement
ELISA

Secondary outcomes

1

Description
Response to treatment
Timepoint
2 months after consumption the Curcumin
Method of measurement
Based on the normalization of Aminotransferases and Gammaglobin levels less than UMN

Intervention groups

1

Description
Intervention group: Patients with standard autoimmune hepatitis treatment protocol with 500 mg per day of curcumin for 2 months
Category
Treatment - Drugs

2

Description
Control group: Patients with standard autoimmune hepatitis treatment protocol with placebo for 2 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Research Hospital
Full name of responsible person
samira shahraki
Street address
Imam Ali Research Hospital, Persian Gulf Highway, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 915 340 9110
Email
shahrakis@zaums.ac.ir

2

Recruitment center
Name of recruitment center
Edaalat Clinic of Zahedan
Full name of responsible person
Hamed taheri
Street address
Health 13, Health Boulevard, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743222
Phone
+98 54 3344 2149
Email
Dr.taheri.113119@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ebrahim Kord
Street address
University 25, University Street, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3337 2116
Email
e.kord58@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Samira Shahraki
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University 25, University Street, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 915 340 9110
Email
shahrakis@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hamed Taheri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Ali Research hospital, Persian Gulf Highway, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743122
Phone
+98 54 3341 2030
Email
Dr.taheri.113119@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Samira Shahraki
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University 25, University Street, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3341 2040
Email
shahrakis@zaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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