The aim of this study was to evaluate the effect of jadwar plant on quality of life and therapeutic indicators in patients deprived of opioid drugs.
Design
A randomized controlled clinical trial and triple blind, parallel study
Settings and conduct
This study is conducted at Shahid Beheshti Hospital in Qom.In this study 60 eligible patients who will be referred with opioid deprivation will be selected and will be randomly assigned to two groups of 30 people. Patients in the control group will receive the standard treatment regimen and placebo. Patients in the treatment group In addition to the standard regimen will be treated with 500 mg of jadwar capsules three times a day for 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria : all patients were abusing opioids for at least 1 year
.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: any allergies to the active ingredient of the drug or side effects. Getting cancer
Intervention groups
Patient deprived of opioids are divided into two groups: jadwar capsules and placebo capsules.
Main outcome variables
The opiate withdrawal score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170112031893N7
Registration date:2020-06-18, 1399/03/29
Registration timing:prospective
Last update:2020-06-18, 1399/03/29
Update count:0
Registration date
2020-06-18, 1399/03/29
Registrant information
Name
Hossein Yusefi
Name of organization / entity
Qom University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 25 3886 0146
Email address
driran1399@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and efficacy of jadwar plant in improving the withdrawal symptoms of opioids: A triple blind trial Study
Public title
Evaluation of safety and efficacy of Jadwar plant in improving the withdrawal symptoms of opioids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients were abusing opioids for at least 1 year
All patients were at the beginning of induction phase of Methadone maintenance treatment protocol
Subjects should not recieve any other medication which affects withdrawal symptoms
Exclusion criteria:
Any allergies to the active ingredient of the drug or side effects
Getting Cancer
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be performed by random numbers generated by a computer (Stat Trek software). From list 1 to 60, this list is randomly divided between the two groups of jadwar and controls, and by considering the numbers, the two groups are randomized. Couples will be in the jadwar group and odd numbers will be in the placebo group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, patients, statistical analyst and physicians are not aware of the allocation of drugs and placebo, and someone outside the group is aware of the allocation of treatment.The placebo is a combination of starch with edible color that is similar to the jadwar capsule.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Vice chancellor for research of Qom University of Medical Sciences, Safashar road, Qom, Iran
City
Qom
Province
Ghoum
Postal code
87366-37169
Approval date
2014-06-03, 1393/03/13
Ethics committee reference number
IR.MUQ.REC.1399.098
Health conditions studied
1
Description of health condition studied
mental and behavioural disorders due to use of opioids
ICD-10 code
F11
ICD-10 code description
Opioid related disorders
Primary outcomes
1
Description
Opiate withdrawal syndrome score
Timepoint
Baseline, 4,8 and12 weeks after starting the medication
Method of measurement
Opiate withdrawal syndrome questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receiving 500 mg capsules of Jadwar plant powder produced by Shefangar Company three times daily for three months
Category
Treatment - Drugs
2
Description
Control group: Patients receiving 500 mg capsules of placebo (Starch) produced by Shefangar Company three times daily for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Addiction treatment centers under the supervision of Qom University of Medical Sciences
Full name of responsible person
Masumeh Akbari
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3886 0146
Email
driran1399@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Ehsan Sharifipour
Street address
Namber 83, Alley 4, Alley 1.1, Safashahr Street
City
Qom
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3285 4011
Email
driran1399@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Yusefi
Position
Non-faculty
Latest degree
Bachelor
Other areas of specialty/work
Health Economy
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3886 0146
Email
driran1390@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Yusefi
Position
Non-faculty
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3886 0146
Email
driran1390@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hosseın Yusefi
Position
Non-faculty
Latest degree
Bachelor
Other areas of specialty/work
Health Economy
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3886 0146
Email
driran1390@yahoo.com
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