(1) Objective: The effect of green tea consumption on the treatment of mild to moderate depression in patients with HIV compared with placebo who are being treated with highly active antiretroviral therapy.(2) Design: Randomized, double blind, controlled clinical trials, single center, phase II prospective clinical trial in Fifty HIV-infected patients. (3) Setting and conduct: Patients referred to Imam Khomeini Hospital Counseling Center during 1396 to 1397 are randomly allocated to the intervention and placebo groups.(4) Participants: Main inclusion criteria are confirmation of HIV infection based on the Western Blot test; diagnosing mild to moderate of depression and have a Hamilton test score of under 20; lack of other psychiatric and cognitive diseases; Major exclusion criteria: Opportunistic infection during 90 days before entering the study; Severe depression and suicidal tendency based on the Hamilton suicide rate score ≥2; have cancer and pregnancy or delivery in three months ago, or breastfeeding; consuming tea and herbal products for 1 week before baseline evaluation and during the study period. (5) Intervention: The intervention group takes every 12 hours of the Green tea capsule (400 mg polyphenol) and the placebo group takes placebo capsule every 12 hours, for 3 months. (6) Main outcome measures: Hamilton score is measured at weeks 6 and 12 and side effects are measured at weeks 1, 6 and 12 in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071128308N2
Registration date:2017-10-14, 1396/07/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-14, 1396/07/22
Registrant information
Name
Ali Asadollahi Amin
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 0856
Email address
emadiham@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2017-11-01, 1396/08/10
Expected recruitment end date
2018-11-01, 1397/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of green tea consumption in the treatment of mild to moderate depression in HIV patients. A randomized, double-blind, controlled clinical trial
Public title
The effect of green tea on the treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : confirmation of HIV infection based on Western blot test; receiving highly active antiretrovirals; diagnosing mild to moderate of depression based on DSM IV criteria (Diagnostic and Statistical Manual of mental disorders) and have a Hamilton test (17 items) score of under 20; satisfaction for research; lack of other psychiatric and cognitive diseases (including AIDS-induced dementia). Exclusion criteria: opportunistic infection 90 days before entering the study; severe depression, and a tendency to suicide based on the Hamilton suicide rate, ≥2; have cancer and pregnancy or delivery in three months ago, or breastfeeding; alcohol dependency; people with malabsorption disorder such as Crohn's disease or chronic pancreatitis; the intake of proton pump inhibitor or H2 blocker; the inability to refrain from drinking tea / tea products (including herbal, caffeine free, caffeine free, Apple juice, chocolate, bean, cherry, juice containing apple, cherry, or plum, food supplements, and herbs for 1 week before baseline evaluation and during the study period.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is done by Permuted-4th block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, School of medicine
City
Tehran
Postal code
Approval date
2017-09-25, 1396/07/03
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.3572
Health conditions studied
1
Description of health condition studied
HIV
ICD-10 code
B24
ICD-10 code description
Unspecified human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Depression
Timepoint
Before intervention, 6 weeks after the intervention and 12 weeks after intervention
Method of measurement
Hamilton Standard Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
A green tea capsule containing 400 mg of green tea polyphenols (GTP) every 12 hours for 12 weeks
Category
Treatment - Drugs
2
Description
A placebo capsule every 12 hours for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Behavioral health counseling center, Imam Khomeini.
Full name of responsible person
Dr. Mousavi
Street address
Imam Khomeini Hospital, End of Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Tehran University of Medical Sciences Headquarters, Keshavarz Blvd., First of Ghods St.,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Ali Asadollahi Amin
Position
Infectious disease specialist
Other areas of specialty/work
Street address
End of Keshavarz Blvd., Imam Khomeini Hospital.
City
Tehran
Postal code
Phone
+98 21 6119 2811
Fax
Email
amiyaneh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Ali Asadollahi Amin
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Imam Khomeini Hospital, End of Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6119 2811
Fax
Email
amiyaneh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Asadollahi Amin
Position
Infectious disease specialist
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 6119 2811
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)