Purpose: assessment effect of habb-o-shefa in maintenance treatment of opiate dependent patients. Design: This study is a randomized double blind placebo controlled. Blindness done for patients and researchers. Inclusion criteria: DSM-IV criteria for addiction healthy medical condition; detoxification at least one month before intervention. Exclusion criteria: Addiction to alcohol ; positive history of other psychological disorders ; pregnancy and breast feeding; serious medical disease ; allergic reaction to medical herbs ; incidence of side effect. People in study: opiate addicted male and females 18-65 years old who referred to addiction treatment centers in Isfahan. Sample size: 60. Intervention: This study will include two groups. Each group will consist of 30 opiate addicted patients. In intervention group capsules containing 500 mg Habb-o-shefa and in control group placebo capsules containing 500 mg sugar three times a day is prescribing for 3 month (12 weeks) .Outcomes are measured by standardized questionnaires in weeks 0, 2, 4,8 and 12 after intervention in two group and will be comprised. Primary outcome: anxiety; craving; quality of life
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101024446N1
Registration date:2015-11-16, 1394/08/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-16, 1394/08/25
Registrant information
Name
Sayyed Abdolali Moosavyzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9073
Email address
alimoosavy@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahed University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of habb-o-shefa in maintenance treatment of opiate dependent person
Public title
effect of habb-o-shefa in treatment of adiction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18 - 65 years old ; DSM-IV criteria for addiction ; healthy condition ; detoxification at least one month before intervention; signed informed consent
Exclusion criteria: Addiction to alcohol ; positive history of other psychological disorders ; taking psychiatric drug ; pregnancy and breast feeding ; serious medical disease such as glaucoma ,retention ,epilepsy ,parkinsonism ; allergic reaction to medical herbs ; incidence of side effect
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahed University
Street address
Shahed University, Opposite of Imam Khomeiny Shrine, Tehran-Qom Freeway
City
Tehran
Postal code
Approval date
2015-03-09, 1393/12/18
Ethics committee reference number
4/1233
Health conditions studied
1
Description of health condition studied
addiction
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
anxiety
Timepoint
Baseline, 4,8 and12 weeks after starting the medication
Method of measurement
Hamilton rating scale for anxiety
2
Description
craving
Timepoint
Baseline, 4,8 and12 weeks after starting the medication
Method of measurement
Craving Beliefs Questionnaire
3
Description
quality of life
Timepoint
Baseline, 4,8 and12 weeks after starting the medication
Method of measurement
wHO-QOL Brief
Secondary outcomes
1
Description
side effect
Timepoint
4,8 and12 weeks after starting the medication
Method of measurement
physical examination and checklist
Intervention groups
1
Description
Intervention group: habb-o-shefa capsule( 500 mg ) dose: 1 cap three time a day for 12 weeks( 3 month)
Category
Treatment - Drugs
2
Description
control group: sugar capsule( 500 mg ) dose: 1 cap three time a day for 12 weeks( 3 month)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Treatment Addiction Centers of Etemad
Full name of responsible person
Sayyed Abdalali Moosavyzadeh
Street address
Amir Building, Ghods square, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahed University of Medical Sciences
Full name of responsible person
Hasan Namdar
Street address
Shahed university, Opposite of Imam Khomeiny shrine, Tehran-Qom freeway
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 of Shahed 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
Shahed University
Full name of responsible person
Sayyed Abdalali Moosavyzadeh
Position
PhD student
Other areas of specialty/work
Street address
Tim Health care, Third Dashtestan Ave, Shariati Ave
City
Tehran
Postal code
Phone
+98 21 2288 2521
Fax
Email
alimoosavy@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohsen Naseri
Position
Associate Professor of Pharmacology
Other areas of specialty/work
Street address
1471 plaque, between Forsat and Nosrat Street, North kargar Avenue, Engelab square
City
Tehran
Postal code
Phone
+98 21 6646 4320
Fax
Email
naseri@shahed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Sayyed Abdalali Moosavyzadeh
Position
PhD student
Other areas of specialty/work
Street address
1471 plaque, between Forsat and Nosrat Street, North kargar Avenue, Engelab square
City
Tehran
Postal code
Phone
+98 21 6646 4322
Fax
Email
alimoosavy@yahoo.com; sa.moosavy@shahed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)