We performed this randomized, double blind, placebo-controlled study to conclude a clinical data in human about the effects of Ginseng on opioid withdrawal symptoms. A total of 36 opioid dependent patients, all male, aged between 18 to 50 who met DSM-IV criteria for opioid dependence and started MMT protocol were randomly assigned to two groups of 18 to receive Ginseng (two 250 mg capsules daily) or placebo for first 15 days of detoxification. Patients were discharged from the study if they had positive urine tests indicating abuse of any drug and also if they missed more than one dose of Ginseng or a dose of methadone. Opioid withdrawal symptoms were measured by the COWS (clinical opioid withdrawal scale) on days 0, 1, 7, 10, 15. Also, the needed methadone dosage was counted everyday to be compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009063106N4
Registration date:2010-11-29, 1389/09/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-29, 1389/09/08
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
1.Goldaroo company 2. Pharmaceutical sciences branch of Islamic Azad university
Expected recruitment start date
2009-07-23, 1388/05/01
Expected recruitment end date
2010-04-21, 1389/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A placebo controlled double-blind add-on study of Ginseng on the opioid withdrawal syndrome
Public title
The effect of Ginseng augmentation on the intensity of opioid withdrawal symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Iinclusion criteria: -all patients were male abusing opioids for at least 1 year -age range was between 18 and 50. -all patients were at the beginning of induction phase of MMT protocol -subjects should not recieve any other medication which affects withdrawal symptoms. Exclusion criteria: -incidence of any allergic effect to ginseng or other ingredients of capsules -patient unlikely to continue the intervention -positive urine tests indicating abuse of any opioid or stimulant drug -missing more than 1 dose of ginseng or a day of methadone treatment
Age
From 18 years old to 50 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
36
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
Pharmaceutical science branch of Islamic azad university
Street address
No 99, Yasaman alley, Yakhchal St, Shariati Av
City
Tehran
Postal code
Approval date
2010-05-23, 1389/03/02
Ethics committee reference number
4115
Health conditions studied
1
Description of health condition studied
opioid withdrawal
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids / Dependence syndrome
Primary outcomes
1
Description
clinical opioid withdrawal symptoms
Timepoint
days 0,1,7,10,15
Method of measurement
clinical opioid withdrawal scale
Secondary outcomes
1
Description
methadone dosage
Timepoint
every day
Method of measurement
base on ducuments and patients records
Intervention groups
1
Description
drug group: patients recieved 250 mg oral capsule of ginseng twice daily for 15 days along with MMT protocol.
Category
Treatment - Drugs
2
Description
placebo group: patients recieved placebo oral capsule of gensing twice daily for 15 days along with MMT protocol.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khane mehr clinic
Full name of responsible person
Dr Hamidreza Mokhberian
Street address
1008, between 1st and 2nd square of Sadeghie
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmaceutical sciences branch of Islamic Azad university
Full name of responsible person
Dr. O. Dadras
Street address
No.99, Yasaman alley, Shariatee street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical sciences branch of Islamic Azad university
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmaceutical science branch of Islamic azad university
Full name of responsible person
Dr. Farshad Hashemian
Position
Assisstani proffesor/clinical pharmasist
Other areas of specialty/work
Street address
99 yasaman, Yakhchal St, Shariati Av.
City
Tehran
Postal code
Phone
+98 9802122606133
Fax
+98 21 8857 7961
Email
hashemian.f@iaups.ac.ir , fhashemian@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)