The purpose of this study was to investigate the effect of Rosemary plant in reducing undesirable symptoms of opium withdrawal syndrome. In this double blind controlled trial, 80 opium addicted persons who are candidates of leaving addiction were assigned in the intervention or control group to receive methadone & rosemary or methadone & placebo for two weeks, retrospectively. Withdrawal signs and symptoms were measured 3, 7, and 14 days after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903054033N1
Registration date:2010-04-21, 1389/02/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-21, 1389/02/01
Registrant information
Name
Hasan Solhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1222 1041
Email address
solhi2@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij essence pharmaceutical co and Arak University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-07-11, 1389/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Rosemarinus officinalis effects on decreasing opium withdrawal syndrome
Public title
Rosemary effects in leaving addiction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 20-60 years, opium consumption less than 2.3g daily, more than a year opium consumption,
Exclusion criteria: known hypersensitivity to rosemary plant, previous history of psychological disorders, incidence of side effects, opium consumption during the study
Age
From 20 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Arak University of Medical Sciences
Street address
Faculty of Medicine, University campus, Sardasht St., Arak
City
Arak
Postal code
Approval date
empty
Ethics committee reference number
88-71-2
Health conditions studied
1
Description of health condition studied
opium addiction
ICD-10 code
F11
ICD-10 code description
mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
heart rate
Timepoint
day before and day 3,7,14 after intervention
Method of measurement
physical exam
2
Description
perspiration
Timepoint
day 3,7,14 after intervention
Method of measurement
opium withdrawal questionnaire
3
Description
pupil size
Timepoint
day 3,7,14 after intervention
Method of measurement
physical exam
4
Description
sialorrhea
Timepoint
day 3,7,14 after intervention
Method of measurement
opium withdrawal questionnaire
5
Description
yawn
Timepoint
day 3,7,14 after intervention
Method of measurement
opium withdrawal questionnaire
6
Description
respiratory rate
Timepoint
day before and day 3,7,14 after intervention
Method of measurement
physical exam
7
Description
sneezing
Timepoint
day 3,7,14 after intervention
Method of measurement
visual analogue scale
8
Description
nausea
Timepoint
day 3,7,14 after intervention
Method of measurement
visual analogue scale
9
Description
vomiting
Timepoint
day 3,7,14 after intervention
Method of measurement
opium withdrawal questionnaire
10
Description
defication
Timepoint
day before and day 3,7,14 after intervention
Method of measurement
opium withdrawal questionnaire
11
Description
insomnia
Timepoint
day 3,7,14 after intervention
Method of measurement
opium withdrawal questionnaire
12
Description
sleep duration in a day
Timepoint
day 3,7,14 after intervention
Method of measurement
opium withdrawal questionnaire
13
Description
muscle jerking
Timepoint
day 3,7,14 after intervention
Method of measurement
visual analogue scale
14
Description
muscle pain
Timepoint
day 3,7,14 after intervention
Method of measurement
visual analogue scale
15
Description
deep tendon reflex
Timepoint
day 3,7,14 after intervention
Method of measurement
physical exam
16
Description
change body temprature feeling
Timepoint
day 3,7,14 after intervention
Method of measurement
visual analogue scale
17
Description
craving
Timepoint
day 3,7,14 after intervention
Method of measurement
visual analogue scale
18
Description
epiphora
Timepoint
day 3,7,14 after intervention
Method of measurement
opium withdrawal questionnaire
19
Description
rhinorroea
Timepoint
day 3,7,14 after intervention
Method of measurement
opium withdrawal questionnaire
20
Description
Social/occupational dysfunction
Timepoint
day 3,7,14 after intervention
Method of measurement
opium withdrawal questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Methadone 5mg tabs po 4 times a day for the first week & 3 times a day for the 2nd week plus placebo capsules
Category
Placebo
2
Description
Methadone 5mg tabs 4 times a day po for the 1st week & 3 times a day for the 2nd week plus Rosemary 300mg capsules, 16 capsules a day po for 3 days then 12 capsules daily for the following 4 days & then 8 capsules daily for the following 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Hassan Solhi, Forensic Sciences and poisoning specialists
Street address
Valiasr hospital, Valiasr square, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hasan Solhi
Street address
Faculty of Medicine, University campus, Sardasht St., Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hasan Solhi
Position
Forensic science and poisoning specialist
Other areas of specialty/work
Street address
Valiasr hospital, Valiasr square, Arak
City
Arak
Postal code
Phone
+98 861222203
Fax
Email
solhi2@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hasan Solhi
Position
Forensic sciences and poisoning specialist
Other areas of specialty/work
Street address
Valiasr hospital, Valiasr square, Arak
City
Arak
Postal code
Phone
+98 86 1222 2003
Fax
Email
solhi2@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seyyed Ali Mohammad Saleh
Position
Medical student
Other areas of specialty/work
Street address
Faculty of Medicine, University campus, Sardasht St., Arak
City
Arak
Postal code
Phone
Fax
Email
ali_saleh2020@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)