]>
IRCT20221112056476N1 IRCT 2024-03-06 Zahedan University of Medical Sciences Evaluation of the effectiveness of Curcumin in the improving patients with autoimmune hepatitis Evaluation of the effectiveness of Curcumin in the improving patients with autoimmune hepatitis 2024-03-10 anticipated 68 Complete https://irct.ir/trial/73910 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Blinding description: People have been blinded: Participant and Data analyzer Curcumin and placebo are completely similar in shape, color and administration method. 1-2 Autoimmune hepatitis. Intervention 1: Intervention group: Patients with standard autoimmune hepatitis treatment protocol with 500 mg per day of curcumin for 2 months. Intervention 2: Control group: Patients with standard autoimmune hepatitis treatment protocol with placebo for 2 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Samira Shahraki
University 25, University Street, Zahedan, Iran
Zahedan Iran (Islamic Republic of) 9816743111 +98 915 340 9110 shahrakis@zaums.ac.ir Zahedan University of Medical Sciences scientific Hamed Taheri
Imam Ali Research hospital, Persian Gulf Highway, Zahedan, Iran
Zahedan Iran (Islamic Republic of) 9816743122 +98 54 3341 2030 Dr.taheri.113119@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 50 years Both K75.4 Autoimmune hepatitis Treatment - Drugs Treatment - Drugs Intervention group: Patients with standard autoimmune hepatitis treatment protocol with 500 mg per day of curcumin for 2 months Control group: Patients with standard autoimmune hepatitis treatment protocol with placebo for 2 months Complete Blood Count (CBC). Timepoint: Before curcumin consumption and 2 months after curcumin consumption. Method of measurement: Blood cells count. Bilirubin (Bill). Timepoint: Before curcumin consumption and 2 months after curcumin consumption. Method of measurement: Based on laboratory tests. Antinuclear antibody. Timepoint: Before curcumin consumption and 2 months after curcumin consumption. Method of measurement: ELISA. Alanine Transaminase (ALT). Timepoint: Before curcumin consumption and 2 months after curcumin consumption. Method of measurement: Based on laboratory tests. Alkaline Phosphatase (ALP). Timepoint: Before curcumin consumption and 2 months after curcumin consumption. Method of measurement: Based on laboratory tests. Aspartate Aminotransferase (AST). Timepoint: Before curcumin consumption and 2 months after curcumin consumption. Method of measurement: Based on laboratory tests. Immunoglobulin G (IgG). Timepoint: Before curcumin consumption and 2 months after curcumin consumption. Method of measurement: ELISA. 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. Zahedan University of Medical Sciences Approved 2023-06-18 Ethics committee of Zahedan University of Medical Sciences University 25, University Street, Zahedan, Iran Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)