Comparison of the average depression score 8 weeks after receiving (drug plus curcumin) and receiving group (drug plus placebo)
Design
A clinical trial with a control group/double blind/randomized with block method/phase 3/on 100 patients
Settings and conduct
The place of research in this study is a psychiatrist's doctor's office in Tabriz city. A written informed consent form will be obtained and a depression and anxiety questionnaire specific to patients with depression and anxiety will be completed before allocation in groups. Then, the participants will be randomized by block method with the size of blocks of four and six and with an allocation ratio of 1:1. They will be assigned to two intervention groups (curcumin capsule recipients) and control groups (placebo recipients). Allocation sequence will be done by someone not involved in sampling and data collection. Curcumin and placebo capsules will be prepared by Dina Pharmaceutical Company in a completely similar way in terms of appearance
Participants/Inclusion and exclusion criteria
Admission of people suffering from depression and anxiety from the age of 18 to 65 years
Exclusion of pregnant and lactating people, people who are allergic to curcumin, people who take other curcumin supplements, and people who have other mental disorders.
Intervention groups
For the intervention group, curcumin capsules with a dose of 500 mg were considered, and for the control group, a placebo for 8 weeks
Main outcome variables
Eight weeks after the start of the intervention, the re-evaluation of depression and anxiety symptoms and quality of life for patients with depression and anxiety will be completed by the participants.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039187N10
Registration date:2023-07-22, 1402/04/31
Registration timing:registered_while_recruiting
Last update:2023-07-22, 1402/04/31
Update count:0
Registration date
2023-07-22, 1402/04/31
Registrant information
Name
Elnaz Shaseb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 2250
Email address
shasebe@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effectiveness of curcumin on depression in patients with depression and anxiety
Public title
The effect of turmeric on depression and anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at least 18 years old and at most 65 years old
Suffering from depression and anxiety
Exclusion criteria:
Allergy to curcumin
pregnancy
breastfeeding
Consumption of curcumin products
Age less than 18 and more than 65 years
Having a mental illness other than depression and anxiety
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be assigned to two groups of intervention (receiver of curcumin capsule) and control (receiver of placebo) by random block method with the size of blocks of four and six and with allocation ratio of 1:1. Allocation sequence will be done by someone not involved in sampling and data collection
Blinding (investigator's opinion)
Double blinded
Blinding description
participant/ investigator
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz university of medical sciences
Street address
Research and technology dept, central building No.2, third floor, tabriz university of medical sciences, golgasht St, tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2023-06-11, 1402/03/21
Ethics committee reference number
IR.TBZMED.REC.1402.197
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate
2
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Symptoms of depression and anxiety
Timepoint
At the beginning of the study and week 4 and week 8
Method of measurement
Hamilton questionnaire for depression and Beck questionnaire for anxiety
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receive 500 mg curcumin capsules for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: placebo recipient
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Elnaz shaseb
Street address
Pharmacy faculty of tabriz medical university, golgasht St, azadi avenue, tabriz