IRCT | Evaluation of the effect of oral Curcumin on Liver enzymes and Liver T2*MRI in patients with major and intermediate Thalassemia at Amirkabir hospital in Arak in 2020.

Protocol summary

Study aim: The effect of oral curcumin on liver enzymes and liver T2 * MRI in patients with thalassemia major and intermediate is determined.
Design: The clinical trial has two intervention and control groups, double-blind, randomized on 60 patients. For randomization, the block method is used using 4 blocks (AABB, ABBA, BABA, etc.).
Settings and conduct: In this study, there are two groups of intervention and control. The intervention group will be given curcumin and the control group will be given a placebo. Both groups receive the same medication for 6 months. The required information will be collected at Amirkabir Hospital in Arak. This study is a double-blind study. Participants will be blinded using the same appearance of curcumin and placebo, and patients have no idea which group they belong to. Also, the researcher who gives the drugs to the two groups will not be aware of the type of drug and the researcher will be blinded in this way.
Participants/Inclusion and exclusion criteria: Age over 5 years old; patients with thalassemia major and intermedia; having conscious satisfaction; no contraindications to the drug under study (curcumin); do not take drugs that affect liver metabolism and liver enzymes and ferritin levels; no liver problems or pregnancy; no history of turmeric allergy.
Intervention groups: Participants in the intervention group will be given curcumin capsules twice a day for 6 months. The control group will be given a placebo. The appearance and dosage of this drug will be similar to curcumin.
Main outcome variables: Liver iron load as a result of this study was investigated that is one of common problems in patients with thalassemia major and intermedia. Initially, the levels of liver enzymes and bilirubin (total and direct) and ferritin will be measured and liver T2 * MRI will be performed for patients and these cases will be compared with the end of the intervention.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20200807048328N1

Registration date: 2020-10-28, 1399/08/07

Registration timing: retrospective

Last update: 2020-10-28, 1399/08/07

Update count: 0
Registration date: 2020-10-28, 1399/08/07

Registrant information: Name

Arash Vahdati

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 86 3402 0470

Email address

arashvhdt@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2020-06-21, 1399/04/01
Expected recruitment end date: 2020-09-22, 1399/07/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Evaluation of the effect of oral Curcumin on Liver enzymes and Liver T2*MRI in patients with major and intermediate Thalassemia at Amirkabir hospital in Arak in 2020.

Public title: Effect of Curcumin on Liver enzymes and Liver T2*MRI in patients with Thalassemia.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Age over 5 years old. Patients diagnosed with Thalassemia major and intermedia. Having conscious satisfaction.

Exclusion criteria:

Pregnancy. History of liver disease. Consumption of drugs affecting liver metabolism and liver enzymes and ferritin levels. History of turmeric allergy. Having bleeding disease. Taking anticoagulants.
Age: From 5 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Investigator

Sample size

Target sample size: 60

Randomization (investigator's opinion)

Randomized

Randomization description

The stochastic method of this study will be block type using 4 blocks (AABB, ABBA, BABA, etc.). For this purpose, the letter Intervention (I) is written on two cards and the letter Control (C) is written on two cards. To hide, the cards are placed in the envelope and turned upside down several times so that the order is not clear. Upon arrival of each participant, a card is selected for him and the selected card is discarded. This is also done for the next three patients to identify 4 people. Then, in the same way, randomization will be done for other groups of 4 to achieve the desired sample size. Then, after randomization and assigning the person to one of the groups, the necessary tests mentioned above are performed for him. The drug is then given to the person for 6 months as mentioned above and every month and after 6 months, tests are performed for him again. In addition, at the beginning of the project, informed written consent and demographic information such as age, sex, height, weight and body mass index will be completed.

Blinding (investigator's opinion)

Double blinded

Blinding description

This study is a double-blind study. Participants will be blinded using the same appearance of curcumin and placebo, and patients have no idea which group they belong to. Also, the researcher who gives the drugs to the two groups will not be aware of the type of drug and the researcher will be blinded in this way.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Arak University of Medical Sciences

Street address

Second floor, Research Deputy Building, Complex of Payambare Azam, Basij Square (Sardasht)

City

Arak

Province

Markazi

Postal code

3819693345
Approval date: 2020-10-05, 1399/07/14
Ethics committee reference number: IR.ARAKMU.REC.1399.203

Health conditions studied

1

Description of health condition studied: Iron Overload in Beta Thalassaemia Major and Intermedia patients
ICD-10 code: D56
ICD-10 code description: Thalassemia

Primary outcomes

1

Description: Aspartate aminotransferase
Timepoint: At the beginning of the study and every month for up to 6 months.
Method of measurement: Patient blood sample.

2

Description: Alanine transaminase
Timepoint: At the beginning of the study and every month for up to 6 months.
Method of measurement: Patient blood sample.

3

Description: Alkaline phosphatase
Timepoint: At the beginning of the study and every month for up to 6 months.
Method of measurement: Patient blood sample.

4

Description: Total bilirubin.
Timepoint: At the beginning of the study and every month for up to 6 months
Method of measurement: Patient blood sample.

5

Description: Direct bilirubin
Timepoint: At the beginning of the study and every month for up to 6 months
Method of measurement: Patient blood sample

6

Description: Serum Ferritin
Timepoint: At the beginning of the study and every month for up to 6 months
Method of measurement: Patient blood sample

7

Description: T2*-weighted imaging
Timepoint: At the beginning of the study and 6 months later
Method of measurement: Magnetic resonanse imaging machine

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: participants in the intervention group will be given the drug curcumin karen containing 95% turmeric extract. This drug will be given as a capsule in the amount of 500 mg twice a day, daily for 6 months.
Category: Treatment - Drugs

2

Description: Control group: a placebo will be given to participants in the control group. The appearance of this drug will be exactly the same as curcumin (we put it in similar pillboxes) and 2 capsules a day for up to 6 months will be given to patients in this group.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Amirkabir hospital

Full name of responsible person

Arash Vahdati

Street address

Amirkabir hospital, Parastar Square, Shahid shirudy Ave, Arak Town

City

Arak

Province

Markazi

Postal code

٣٨١٩٦٩٣٣٤٥

Phone

+98 86 3313 5075

Fax

+98 86 3313 2510

Email

It@arakmu.ac.ir

Web page address

https://arakmu.ac.ir/amirkabirhos/fa

1

Sponsor: Name of organization / entity

Arak University of Medical Sciences

Full name of responsible person

Dr Kamali

Street address

Vice Chancellor for Research and Technology, Payambar Azam University Complex, Arak University of Medical Sciences, Basij Square (Sardasht)

City

Arak

Province

Markazi

Postal code

3848176341

Phone

+98 86 3417 3639

Fax

+98 86 3417 3645

Email

research@arakmu.ac.ir

Web page address

https://www.arakmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Arak 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

Arak University of Medical Sciences

Full name of responsible person

Arash Vahdati

Position

Intern

Latest degree

A Level or less

Other areas of specialty/work

General Practitioner

Street address

Second floor, Research Deputy Building, Complex of Payambare Azam, Basij Square (Sardasht)

City

Arak

Province

Markazi

Postal code

3819693345

Phone

+98 86 3417 3645

Fax

Email

research@arakmu.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Arak University of Medical Sciences

Full name of responsible person

Arash Vahdati

Position

Intern

Latest degree

A Level or less

Other areas of specialty/work

General Practitioner

Street address

Second floor, Research Deputy Building, Complex of Payambare Azam, Basij Square (Sardasht)

City

Arak

Province

Markazi

Postal code

3819693345

Phone

+98 86 3417 3645

Fax

Email

research@arakmu.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Arak University of Medical Sciences

Full name of responsible person

Arash Vahdati

Position

Intern

Latest degree

A Level or less

Other areas of specialty/work

General Practitioner

Street address

Second floor, Research Deputy Building, Complex of Payambare Azam, Basij Square (Sardasht)

City

Arak

Province

Markazi

Postal code

3819693345

Phone

+98 86 3417 3645

Fax

Email

research@arakmu.ac.ir

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

Evaluation of the effect of oral Curcumin on Liver enzymes and Liver T2*MRI in patients with major and intermediate Thalassemia at Amirkabir hospital in Arak in 2020.