Evaluation of the effects of berberis vulgaris L. on the treatment of opiate withdrawal syndrome
Design
Half of the patients are randomly selected as the control group and the other half are selected as the target group. Both groups are treated with methadone and the daily dose of methadone is adjusted daily by the physician so that the signs and symptoms of substance abuse are eliminated and, if necessary, the dose is gradually increased (maximum 5-10 mg per day. The capsules filled with powdered dried plant root extract powder are given to patients in the case group (500 mg, twice a day) and capsules containing the ineffective starch (placebo). ) Control group patients are prescribed. Questionnaires assessing depression, anxiety, sleep quality, and withdrawal symptoms are completed on days 0, 3, 7, 14, and 28 by the researcher.
Settings and conduct
This study was performed to investigate the effect of barberry extract on the symptoms of opioid recovery and psychological symptoms. Patients are randomly selected and the patient and physician are unaware of the content of the capsules received.
Participants/Inclusion and exclusion criteria
Inclusion criteria: opioid addiction; age between 20-60 years old with no history of medical comorbidities and history of allergy to this plant.
Exclusion criteria: non-continuation of treatment; sensitivity to plant extracts and continued use of opiates during treatment.
Intervention groups
The control group that will receive the placebo and the intervention group that will receive the plant extract.
Main outcome variables
Withdrawal symptoms; neurological problems and duration of methadone treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180114038356N3
Registration date:2020-07-16, 1399/04/26
Registration timing:retrospective
Last update:2020-07-16, 1399/04/26
Update count:0
Registration date
2020-07-16, 1399/04/26
Registrant information
Name
Somayyeh Karami-Mohajeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5001
Email address
somayyehkarami@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-19, 1398/01/30
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of berberis vulgaris L. on the treatment of opiate withdrawal syndrome
Public title
Investigating the effects of berberis vulgaris L. on the treatment of opiate withdrawal syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Opioid addiction of at least 2.3 grams per day continuously for at least one year,
Age between 20-60 years old
No history of medical comorbidities
No history of allergies to this plant
Exclusion criteria:
History of medical comorbidities
History of allergies to this plant
Do not take the capsules
Dissatisfaction with methadone dose reduction
Intolerance to some of side effects of the extract, such as dry mouth
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization. The size of each block was 4 people. In this way, the first block is given the capsule with code 1 and the second block is given the capsule with code 2 and the 3rd block is given the capsule with code 1 again and so on.
Blinding (investigator's opinion)
Single blinded
Blinding description
The capsules were given to the treating physician with a code, and patients are not aware of the contents of the capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Ebn-e-Sina St., Jahad Blvd., Kernan, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2018-05-12, 1397/02/22
Ethics committee reference number
IR.KMU.REC.1397.205
Health conditions studied
1
Description of health condition studied
Patients addicted to opioids treated with methadone
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
Examination of opioid withdrawal symptoms and neurological complications with the questionnaires
Timepoint
Before intervention and 7, 14 and 28 days after intervention
Method of measurement
Questionnaires
Secondary outcomes
1
Description
Assessment of depression, anxiety, sleep quality
Timepoint
Before intervention and 7, 14 and 28 days after intervention
Method of measurement
Questionnaires
Intervention groups
1
Description
Intervention group: 28 patients under methadone therapy will be assigned to the treatment group to receive the extract (500 mg, twice a day for 30 days).
Category
Treatment - Drugs
2
Description
Control group: 28 patients under methadone therapy will be assigned to the control group to receive the placebo (500 mg, twice a day for 30 days).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Addiction treatment clinics in Kerman
Full name of responsible person
Dr. Mahin Eslami
Street address
Shahid Beheshti Educational Center, Jomhuri Eslami Blvd.
City
Kerman
Province
Kerman
Postal code
8-32111006
Phone
+98 34 3211 1006
Email
h_beheshti@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Prof. Abbas Pardakhti
Street address
Ebn-e-Sina St., Jahad Blvd., Kernan,Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Somayyeh Karami-Mohajeri
Position
Assistance prof.
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 4142 5001
Email
somayyehkarami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Somayyeh Karami Mohajeri
Position
assistance prof
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5001
Email
somayyehkarami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Somayyeh Karami-Mohajeri
Position
Assistance prof
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5001
Email
Somayyehkarami@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Part of the data, such as information about the main consequence or the like, can be shared.
When the data will become available and for how long
after publication
To whom data/document is available
people working in academic institutions or people working in businesses
Under which criteria data/document could be used
meta analysis
From where data/document is obtainable
Email of the main executor of the project
What processes are involved for a request to access data/document
Review the request by the project executor, consult with other colleagues, announce the result