Protocol summary

Study aim
Determining the effect of curcumin supplementation on depression, anxiety, pain and BDNF serum concentration in patients with gastrointestinal cancer, treated in hospitals covered by Zahedan University of Medical Sciences.
Design
A concealed, randomized, blinded, sham controlled clinical trial with a parallel group
Settings and conduct
In this research, 64 patients with gastrointestinal cancer referred to the hospitals covered by Zahedan University of Medical Sciences were included in the study. Then, the patients were divided into two intervention and placebo groups using the permutation block stratified randomization method (patients were matched in terms of age and blinding was double-blind, with blinding of the researcher and statistical consultation).
Participants/Inclusion and exclusion criteria
In this study, male patients over 18 years of age, who have passed at least 6 months since the onset of the disease and met the criteria of depression according to DSM-V criteria and did not have contraindications for curcumin consumption, were included in the study. Also, in this research, patients with end-stage cancer, or with panic disorder, bipolar disorder, co-occurring obsessive-compulsive disorder, post-traumatic stress disorder, eating disorder, or any substance abuse or dependence disorder, and people at high risk of suicide or patients with Clinical diseases such as diabetes, autoimmune diseases, cardiovascular diseases, high blood pressure, Alzheimer's disease, Parkinson's disease, stroke and multiple sclerosis, chronic fatigue syndrome, fibromyalgia and asthma were excluded from the study.
Intervention groups
Curcumin group - placebo group
Main outcome variables
Depression, anxiety, pain, BDNF

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240521061860N1
Registration date: 2024-07-13, 1403/04/23
Registration timing: registered_while_recruiting

Last update: 2024-07-13, 1403/04/23
Update count: 0
Registration date
2024-07-13, 1403/04/23
Registrant information
Name
Yalda Sargazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3322 6701
Email address
hafezi61mokhtar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of curcumin supplementation on depression, anxiety, pain and BDNF serum concentration in patients with gastrointestinal cancer
Public title
the effect of curcumin supplementation on depression, anxiety, pain and BDNF serum concentration in patients with gastrointestinal cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Men over 18 years old with gastrointestinal cancers At least 6 months have passed since the onset of the disease. They must meet the depression criteria according to DSM-5 criteria They must be willing to participate in the study. do not have any contraindications for prescribing curcumin. No previous use of pharmaceutical antidepressants, no use of cigarettes and curcumin supplements.
Exclusion criteria:
People who are in the end stage of cancer. Do not want to participate in the study. Do not have depression criteria. Patients under 18 years old Patients with panic disorder, bipolar disorder, co morbid obsessive-compulsive disorder, post traumatic stress disorder, eating disorder, or any substance abuse or dependence disorder and people at high risk of suicide. Patients with medical diseases such as diabetes, autoimmune diseases, cardiovascular diseases, high blood pressure, Alzheimer's disease, Parkinson's disease, stroke and multiple sclerosis, chronic fatigue syndrome, fibromyalgia and asthma.
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of patients to two groups is done by permuted block stratified randomization method. In this study, first, a replacement block sample was designed by R statistical software, and the studied population will be included in the study after being examined in terms of entry and exit criteria.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, the double-blind method is used, So the researcher and statistical consultant will not be aware of the desired intervention. In fact, after entering the research, the patients will be blinded by the person responsible for implementing the plan, and during the research, the researcher responsible for the treatment of the patients and the data analyst will not be aware of the names of the groups, and the groups will be named with English letters.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Zahedan University Of Medical Sciences
Street address
Medical Sciences Campus, Doctor Hasabi Square, Zahedan City
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2024-05-12, 1403/02/23
Ethics committee reference number
IR.ZAUMS.REC.1403.094

Health conditions studied

1

Description of health condition studied
Gastrointestinal Malignancy
ICD-10 code
C26.9
ICD-10 code description
Malignant neoplasm of ill-defined sites within the digestive system

Primary outcomes

1

Description
Depression
Timepoint
Before starting the intervention, after completing the treatment period
Method of measurement
Beck depression questionnaire

2

Description
Anxiety
Timepoint
Before starting the intervention, after completing the treatment period
Method of measurement
Beck's anxiety questionnaire

3

Description
Pain
Timepoint
Before starting the intervention, after completing the treatment period
Method of measurement
Pain Self-Efficacy Questionnaire

4

Description
BDNF
Timepoint
Before starting the intervention, after completing the treatment period
Method of measurement
ELISA method

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: combined treatment with curcumin - patients who receive 80 mg of Curcumin Elixir Nano Sina capsules along with antidepressants from the SSRI group including fluoxetine capsules with a dose of 20 to 60 mg daily.
Category
Treatment - Drugs

2

Description
Control group: standard treatment with fluoxetine - patients who receive antidepressants along with placebo.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Radio-Oncology Clinic, Ali Ebn Abitaleb Hospital, Zahedan
Full name of responsible person
Dr. Pegah Sasanpour
Street address
Ali Ebn Abitaleb Hospital, Persian gulf highway, Zahden City
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5570
Email
hafezi61mokhtar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Kord
Street address
Medical Sciences Campus, Doctor Hasabi Square, Zahedan City
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
zaums.research@zaums.ac.ir
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
Dr. Yalda Sargazi
Position
Psychiatry specialist assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Medical Sciences Campus, Doctor Hasabi Square, Zahedan City
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
hafezi61mokhtar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mansour Shakiba
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Medical Sciences Campus, Doctor Hasabi Square, Zahedan
City
Zahean
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
dr.mansoorshakiba2006@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Yalda Sargazi
Position
Psychiatry specialist assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Medical Sciences Campus, Doctor Hasabi Square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
hafezi61mokhtar@gmail.com

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is from the proposal, raw data and project reports.
When the data will become available and for how long
Data is available from the legal system six months after publication for two years
To whom data/document is available
All persons will be able to access the Zahedan University of Medical Sciences's request to the Kurdistan University of Medical Sciences.
Under which criteria data/document could be used
For legal issues and the need to use data in future studies
From where data/document is obtainable
Dr. Yalda Sargazi
What processes are involved for a request to access data/document
After submitting a request to the Zahean Research and Technology Dept. of Science and Technology, a call for submission is given.
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