purpose: Comparison Effect of Matricaria chamomilla and Trachyspermum copticum on Withdrawal syndrome in Narcotics Anonymous.
Study design: triple blind clinical trial with a control group.
Inclusion criteria were: age between 18 to 100 years, having opium addiction, man
Exclusion criteria: known underlying disease (physical and mental); Mental retardation; taking other pain medication or herbs in order to reduce symptoms, patients taking methadone, having allergy to drug plants
Sample size: 135
Interventions studied: after sampling, Samples with randomization divided in 2 case and control group.
Intervention group 1: will take Matricaria chamomilla (oral drops) 3cc (TDS) one hours post parandial and intervention group 2 patients will receive Trachyspermum copticum (oral drops) similar.control group Controls the amount of Clonidine tablets daily 2 mg is given
Intervention time: two months
Primary outcome: reduction of the uncomfortable symptoms of drug addiction.
Data collection Instrument: Questionnaire symptoms of opiate withdrawal syndrome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309053227N4
Registration date:2015-08-19, 1394/05/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-19, 1394/05/28
Registrant information
Name
Ashraf Salehi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 5222 7550
Email address
salehi.a@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Effect of Matricaria chamomilla and Trachyspermum Copticum on Withdrawal Syndrome in Narcotics Anonymous
Public title
Effect of Matricaria chamomilla and Trachyspermum Copticum on Addiction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 to 100 years, having opium addiction, man.
Exclusion criteria: known underlying disease (physical and mental); Mental retardation; taking other pain medication or herbs in order to reduce symptoms, patients taking methadone,having allergy to drug plants
Age
From 18 years old to 100 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not 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
Iran-arak-Arak University of Medical Sciences
City
Arak
Postal code
Approval date
2013-08-23, 1392/06/01
Ethics committee reference number
5-150-92
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
Resting Pulse Rate
Timepoint
2,5,12,19,26 days
Method of measurement
clinical opiate withdrawal scale
2
Description
GI Upset
Timepoint
2,5,12,19,26 days
Method of measurement
clinical opiate withdrawal scale
3
Description
Sweating
Timepoint
2,5,12,19,26 days
Method of measurement
clinical opiate withdrawal scale
4
Description
Tremor
Timepoint
2,5,12,19,26 days
Method of measurement
clinical opiate withdrawal scale
5
Description
Restlessness
Timepoint
2,5,12,19,26 days
Method of measurement
clinical opiate withdrawal scale
6
Description
yawning
Timepoint
2,5,12,19,26 days
Method of measurement
clinical opiate withdrawal scale
7
Description
pupil size
Timepoint
2,5,12,19,26 days
Method of measurement
clinical opiate withdrawal scale
8
Description
anxiety or irritability
Timepoint
2,5,12,19,26 days
Method of measurement
clinical opiate withdrawal scale
9
Description
bone or joint aches
Timepoint
2,5,12,19,26 days
Method of measurement
clinical opiate withdrawal scale
10
Description
gooseflesh skin
Timepoint
2,5,12,19,26 days
Method of measurement
clinical opiate withdrawal scale
11
Description
runny nose or tearing
Timepoint
2,5,12,19,26 days
Method of measurement
clinical opiate withdrawal scale
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group 1: will take Matricaria chamomilla 20% (oral drops)3cc, TDS, one hours post parandial for one month
Category
Treatment - Drugs
2
Description
in intervention group 2 patients will receive Trachyspermum copticum10%(oral drops), 3cc, TDS for one month
Category
Treatment - Drugs
3
Description
In control group will take tab clonidin 2 mg per day with in a period one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Narcotics Anonymous Camps khomein City
Full name of responsible person
Hamid Momeni
Street address
Arak University Of Medical Science
City
khomein
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiei
Street address
Arak University of Medical Sciences
City
Arak, Shahid Shiroudi, Alamolhoda, University of Medical Sciences
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 Science
Full name of responsible person
Ashraf Salehi
Position
Academic Member Of khomain-college of Medical Science
Other areas of specialty/work
Street address
khomain Medical Science Faculty
City
khomain
Postal code
Phone
+98 86 4622 4143
Fax
Email
najm54@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamid Momeni
Position
MSN
Other areas of specialty/work
Street address
khomein Medical Science Faculty
City
khomein
Postal code
Phone
+98 86 4622 4143
Fax
Email
hamid52us@tahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamid Momeni
Position
Other areas of specialty/work
Street address
khomain Medical Science Faculty
City
Khomain
Postal code
Phone
+98 86 4622 4143
Fax
Email
hamid52us@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)