The purpose of this study is to reduce the daily dose of methadone to reduce its side effects and supplement barberry.
Design
This is a double-blind clinical trial (Phase 3) that is conducted on clients referring to addiction treatment centers in Sabzevar Of the eligible individuals (obtaining informed consent, having complete vigilance and not taking another drug by the patient), 40 are selected (two groups of 20).
Settings and conduct
This study was performed on 40 patients referring to addiction treatment centers in Sabzevar, which are in the stage of stabilization of treatment (methadone and methadone dose on a weekly basis). The intervention group was treated with methadone syrup and barberry self-made capsules and the control group received methadone and placebo syrup for 2 months.
Participants/Inclusion and exclusion criteria
Getting informed consent and having full vigilance and no other drug use by the patient
Intervention groups
The intervention group was treated with methadone syrup and barberry self-made capsules and the control group received methadone and placebo syrup for 2 months.
Main outcome variables
Each week, variables: Renorrhea, muscle aches, appetite loss, obsession and diarrhea are recorded in the self-designed checklist.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170404033202N5
Registration date:2017-11-29, 1396/09/08
Registration timing:prospective
Last update:2017-11-29, 1396/09/08
Update count:0
Registration date
2017-11-29, 1396/09/08
Registrant information
Name
Atefeh Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 9180
Email address
a.asadi.mm.1384@gmail.com
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Barberry and Placebo on the symptoms of Turkish syndrome in patients undergoing methadone maintenance treatment
Public title
Effect of Barberry on the symptoms of withdrawal syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acquiring informed consent; Having full vigilance when completing the consent form; Accompanying a trusted person in the family
Exclusion criteria:
Existence of illness; The use of another drug by the patient
Age
From 60 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug (powdered Barberry) and the medication in the capsules of the same type are packed in A and B. Researcher and patients are not aware of the content, and then the data analysis will be presented to examine the outcome of the type A and B groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Central University, Asadabad Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Approval date
2017-12-22, 1396/10/01
Ethics committee reference number
IR.Medsab.Rec.1395.146
Health conditions studied
1
Description of health condition studied
Addiction syndrome
ICD-10 code
f10-f11-f1
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance use
Primary outcomes
1
Description
Rhinorrhea
Timepoint
Every week up to 2 months
Method of measurement
Checklist
2
Description
diarrhea
Timepoint
Every week up to 2 months
Method of measurement
Checklist
3
Description
Reduce appetite
Timepoint
Every week up to 2 months
Method of measurement
Checklist
4
Description
Dyspnea
Timepoint
Every week up to 2 months
Method of measurement
Visual Scale of Pain
5
Description
Obsession
Timepoint
Every week up to 2 months
Method of measurement
Test Beck
Secondary outcomes
1
Description
Occupation
Timepoint
first
Method of measurement
chek List
2
Description
Age
Timepoint
first
Method of measurement
Birth certificate
3
Description
Sex
Timepoint
first
Method of measurement
male - female
Intervention groups
1
Description
Intervention group: During the 2 months of the study, methadone syrup and barberry cream capsules (250 mg of barberry dried extract of barberry powder were shed)
Category
Treatment - Drugs
2
Description
Control group: During the 2 months of the study, methadone and placebo syrup (color and size similar to barberry capsules) were treated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Addiction Clinic Behzist
Full name of responsible person
Atefeh Asadi
Street address
Floor (-1), Deputy Medical Building, no. 15, Kashefialasl Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 51 4422 9180
Email
a.asadi.mm.1384@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh GHorat
Street address
Pardiss of University, Kosar street, Toohid Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 51 4401 1035
Email
ghorat.f@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Atefeh Asadi
Position
General Peractis
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Department of Health، Talghani Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 51 4422 9180
Fax
Email
a.asadi.mm.1384@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Nematshahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Central University، Asadabad Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 51 4422 9180
Fax
Email
9157638703mn@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Atefeh Asadi
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Department of Health، Taleghani street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 51 4422 9180
Fax
Email
a.asadi.mm.1384@gmail.com
Web page address
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