Determining the effectiveness of ginseng on the symptoms of depression and anxiety in drug users
Design
A clinical trial with a control group, with parallel groups, double-blind
, randomized, phase 3 on 34 patients. Random list by
A statistician was prepared
Settings and conduct
Patients referred to the drug addiction clinic of Golestan Hospital and undergoing maintenance treatment with methadone and buprenorphine with drug dependence for at least one year, have been using drugs at a fixed dose for at least one month, are divided into two experimental and control groups. Blinding It is done in a two-way blind way. The experimental group, the control group, and all the researchers related to the patients are unaware of the drug or placebo received. Evaluation and analysis of the results is done by someone outside the treatment team. A limited random sequence is generated by a random assignment rule by a person outside the treatment group. Then, based on the volume, a number of non-transparent letter envelopes are prepared and each of the randomly created sequences is recorded on a card and the cards are placed inside the letter envelopes in order. To maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Drug users who are undergoing maintenance treatment with methadone and buprenorphine in the age range of 18 to 60 years
Exclusion criteria: Pregnant or lactating mothers
Intervention groups
One group of patients (34 people) will receive Jaising capsules (100 mg) and the other group (34 people) will receive a placebo for 4 weeks
Main outcome variables
Changes in symptoms of depression and anxiety in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240310061238N1
Registration date:2024-04-10, 1403/01/22
Registration timing:prospective
Last update:2024-04-10, 1403/01/22
Update count:0
Registration date
2024-04-10, 1403/01/22
Registrant information
Name
Seyede Fateme MESBAHI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5242 8035
Email address
fatememesbahi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2024-12-05, 1403/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of ginseng on the symptoms of depression and anxiety in drug users
Public title
Effectiveness of Ginseng on the Symptoms of depression and anxiety in Drug users
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Drug users who are undergoing maintenance treatment with methadone and buprenorphine in the age range of 18 to 60 years will be included in the study.
Drug-dependent patients for at least one year using fixed-dose drugs at least in the last month
Exclusion criteria:
Pregnant or lactating mothers
Patients with other psychological problems (bipolar-schizophrenia-dementia or mental retardation)
Concomitant serious medical diseases
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the size of the blocks will be equal. Patients are included in the study in order of referral. Distribution of patients with a ratio of 1:1 and by 17 blocks (the length of each block is 2) (the sample size is
Study 34) will be done. Randomization sequence using software
Create a randomization command in the Excel program (RandomBetween).
will be.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient is treated with drug packages selected by the supervisor. The drug packages are completely similar in shape and the patient and operator are not aware of their content. Also, collecting information, evaluating patients, and completing the forms are done by the operator and his assistant. They are not aware of the contents of the package. The stage of data analysis is also done by the operator will be carried out and only the group of patients (groups 1 and 2) will be analyzed when the data is specified. Therefore, this study is double-blind
and the stage of entering the patient until operating the study, collecting data, and analyzing information contents of the two drug groups are unknown
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committe of Ahvaz Jondishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Approval date
2024-02-28, 1402/12/09
Ethics committee reference number
IR.AJUMS.REC.1402.644
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
2
Description of health condition studied
Anxiety
ICD-10 code
F39
ICD-10 code description
Unspecified mood [affective] disorder
Primary outcomes
1
Description
Anxious mood score with Hamilton questionnaire criteria
Timepoint
Examining the anxiety score with the Hamilton questionnaire, at the beginning of the study (before the start of the intervention), and 14 and 28 days after receiving ginseng.
Method of measurement
Hamilton anxiety and depression questionnaire
2
Description
Depressed mood score with Hamilton questionnaire criteria
Timepoint
Examining the depression score with the Hamilton questionnaire, at the beginning of the study (before the start of the intervention), and 14 and 28 days after receiving ginseng.
Method of measurement
Hamilton anxiety and depression questionnaire
Secondary outcomes
1
Description
Sleep disorder score with Hamilton questionnaire criteria
Timepoint
Examining the sleep disorder score with the Hamilton questionnaire, at the beginning of the study (before the start of the intervention), and 14 and 28 days after receiving ginseng.
Method of measurement
Hamilton anxiety and depression questionnaire
2
Description
Diminished ability to concentrate score with Hamilton questionnaire criteria
Timepoint
Examining the difficulty in concentration score with the Hamilton questionnaire, at the beginning of the study (before the start of the intervention), and 14 and 28 days after receiving ginseng.
Method of measurement
Hamilton anxiety and depression questionnaire
3
Description
General physical condition score with Hamilton questionnaire criteria
Timepoint
Examining the score of general physical symptoms with the Hamilton questionnaire, at the beginning of the study (before the start of the intervention), and 14 and 28 days after receiving ginseng.
Method of measurement
Hamilton anxiety and depression questionnaire
Intervention groups
1
Description
Intervention group: Patients receive ginseng capsules (100 mg) . The intervention group received two ginseng capsules (100 mg) daily for four weeks.
Category
Treatment - Other
2
Description
Patients receive placebo capsules, which are similar to ginseng capsules (in terms of shape, smell, taste, size, and color), from starch powder with an approved color, which is made by the pharmacy laboratory of the Faculty of Pharmacy of Ahvaz University of Medical Sciences, for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital clinic
Full name of responsible person
Seyede Fateme Mesbahi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd,
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 5242 8035
Email
fatememesbahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sahand Jourfi
Street address
Department of Psychiatry,Golestan Hospital,Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3447 3333
Email
fatememesbahi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Seyede Fateme Mesbahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Golestan hospital, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+9861330383374
Email
fatememesbahi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyede Fateme Mesbahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry Golestan Hospital,Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3038 3374
Email
fatememmesbahi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyede Fateme Mesbahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Golestan hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3038 3374
Email
fatememesbahi@yahoo.com
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