Evaluation of the effect of clove-based Iranian traditional medicine (Eugenia Caryophyllata) On improving the score of Hamilton questionnaire in patients with depression
Determining and comparing level of depression in patients receiving traditional Iranian medicine based on cloves and placebo 2, 4 and 6 weeks after treatment
Design
A clinical trial with a control group, with parallel groups, double-blind, phase 2-3, was performed on 62 patients, randomized with random number generator software.
Settings and conduct
This study was performed on patients referred to 505 AJA (The Islamic Republic of Iran Army) Psychiatric Hospital who were diagnosed with major depression by psychiatrists based on DSM-5 (Diagnostic and Statistical Manual of Mental Disorders). In addition to the main treatment with citalopram, patients were given medication or placebo and the patient's depression status was assessed at 2, 4 and 6 weeks after starting treatment. The patient and the researcher were blinded to the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
A score of 19 or higher on the 17-item HAM-D (hamilton depression scale) scoring tool and a score of 2 or higher on the first HAM-D item
No entry conditions:
Received any type of antidepressant in the past months
Received an electric shock during the last 2 months
Have evidence in favor of psychosis or other mental illness
Suicidal thoughts (score higher than 2 on HAM-D suicide item)
Addiction or abuse of alcohol or other substances (excluding nicotine)
Uncontrollable physical diseases such as thyroid, heart and liver diseases
Intervention groups
All patients will be treated with citalopram 10 mg daily for two weeks and then 20 mg daily. Participants are randomly divided into two groups; The first group is given the product of traditional Iranian medicine based on cloves at a dose of 250 mg per day and the second group is given a placebo for six weeks.
Main outcome variables
Hamilton Depression Inventory; Side effects of the drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220426054668N1
Registration date:2022-06-21, 1401/03/31
Registration timing:retrospective
Last update:2022-06-21, 1401/03/31
Update count:0
Registration date
2022-06-21, 1401/03/31
Registrant information
Name
Mohammadreza Ghasemzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2248 1806
Email address
m.rezaghasemzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-30, 1400/04/09
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
2021-06-30, 1400/04/09
Actual recruitment end date
2022-03-09, 1400/12/18
Trial completion date
2022-04-20, 1401/01/31
Scientific title
Evaluation of the effect of clove-based Iranian traditional medicine (Eugenia Caryophyllata) On improving the score of Hamilton questionnaire in patients with depression
Public title
Evaluation of the effect of cloves in the treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A score of 19 or higher on the 17-item HAM-D Scoring Tool and a score of 2 or higher on the first HAM-D item
Exclusion criteria:
Received any type of antidepressant in the past months
Received electroshock during the last 2 months
Having evidence in favor of psychosis or other mental illnesses
Suicidal thoughts (score higher than 2 on HAM-D suicide item)
Addiction or abuse of alcohol or other substances (excluding nicotine)
Uncontrollable physical diseases such as thyroid, heart and liver diseases
Patient dissatisfaction with participation in the study
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
62
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients are included in the study and are divided into two groups A and B by sequentially numbered method. Randomization is done by random number generator software in quadruple blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and the physician are both blinded to the treatment received. After obtaining patient information, the researcher gives the patient a sealed envelope that contains code A (a product of traditional medicine based on cloves) or code B (placebo). Without opening the envelope, the patient presents it to the pharmacist's colleague, so that after the relevant code is determined, the drug A or B, which are covered by the manufacturer, will be given to the patient. The pharmacist colleague records the patient's name and code without identifying the medication, and this information will be kept until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of AJA University of Medical Sciences
Street address
AJA University of Medical Sciences, Shaheed Etemadzadeh St, West Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2021-07-03, 1400/04/12
Ethics committee reference number
IR.AJAUMS.REC.1400.084
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Depression score on the Hamilton questionnaire
Timepoint
Before the study, two, four and six weeks after starting treatment
Method of measurement
Hamilton Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Processed clove syrup; One gram of cloves with ten grams of pomegranate juice and one gram of honey are kept in an incubator at 40 ° C for one week. Then the desired syrup is prepared by adding sugar. The product will be stored in a sterile glass container and closed until dark, in the dark and in the refrigerator at 4 ° C. At a dose of 250 mg (3 cc) daily for 6 weeks.
Category
Treatment - Drugs
2
Description
Control group: placebo; Ten grams of pomegranate juice and one gram of honey are stored in an incubator at 40 degrees for one week. Then the desired syrup is prepared by adding sugar. The product will be stored in a sterile glass container and closed until dark, in the dark and in the refrigerator at 4 ° C. At a dose of 3 cc daily for 6 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Artesh 505 Hospital
Full name of responsible person
Mohammadreza ghasemzadeh
Street address
The end of Avshan Boulevard, Artesh Boulevard, Aqdasiyeh
City
Tehran
Province
Tehran
Postal code
4414119569
Phone
+98 21 2248 1806
Email
m.rezaghasemzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mojtaba Yousefi Zoshk
Street address
Aja University of Medical Sciences, Shaheed Etemadzadeh St, West Fatemi Blvd
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
Dr.yousefi.md@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?