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The comparison of the effect of passiflora and piroxicam on the reduction of myalgia on the Patients requesting the leave of Methadone

Protocol summary

Study aim
The purpose of most effective least cost to reduce muscle pain caused by Opiate leave.
Design
This project is a one-stop clinical trial that will be carried out at the Centers for Addictive Disorders in Sabzevar County on 43 individuals who visit the facility (single-phase in Phase 3). Patients are randomly divided into two groups, 20 (control-B) and 23 (intervention group-A), randomly and in combination with codes A and B. The patients are randomly divided into two groups, 20 (control-B) and 23 patients (intervention group A).
Settings and conduct
This plan is a one-stop clinical trial (patients are not informed about the type of medicine, drugs are given as new capsules for the patient), which will be completed at the 43 patients who visit the center of Sabzevar's addiction treatment center. At the same time, with the onset of methadone, the control group, piroxicam, and the intervention group, will be prescribed a pumpkin drop, which should be consumed until the signs of withdrawal and stabilization of methadone dose are resolved
Participants/Inclusion and exclusion criteria
Individuals who enter into the design are logged in, and they should not use alcohol, glass or Druge Injectable .
Intervention groups
At the same time, with the onset of methadone, the control group, piroxicam, and the intervention group, will be prescribed a pumpkin drop, which should be consumed until the signs of withdrawal and stabilization of methadone dose are resolved. In the first days, 3rd, 6th and 9th treatments, the patient's vital signs, muscle pain (based on the visual scale of the pain) and anxiety (based on the test) will be recorded.
Main outcome variables
In the first days, 3rd, 6th and 9th treatments, the patient's vital signs, muscle pain (based on the visual scale of the pain) and anxiety (based on the test) will be recorded.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170404033202N6
Registration date: 2017-12-16, 1396/09/25
Registration timing: prospective

Last update: 2017-12-16, 1396/09/25
Update count: 0
Registration date
2017-12-16, 1396/09/25
Registrant information
Name
Atefeh Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 9180
Email address
a.asadi.mm.1384@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Sabzevar University of Medical Sciences
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of passiflora and piroxicam on the reduction of myalgia on the Patients requesting the leave of Methadone
Public title
Investigation of the effect of passiflora on the reduction of myalgia after the withdrawal of drug addiction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A quit candidate with methadone has personal satisfaction Age of more than 18 and less than 60 years old
Exclusion criteria:
The visual score of pain is greater than 9 co-administration of sadation people with a history of injecting narcotic and scoliosis BMI> 30.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 43
Randomization (investigator's opinion)
Randomized
Randomization description
The envelopes containing the medication are identified as A and B, given randomly and in the same way to patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
The envelopes containing the drug are identified as A and B, which the researcher does not know about envelopes. After the data is recorded by the researcher and the data analyst, the rows A and B will be reported to the researcher for the outcome.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical
Street address
Pardiss University, Kuosar Street, Toohid Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
IR.Medsab.Rec.1395.146

Health conditions studied

1

Description of health condition studied
Musculoskeletal pain and anxiety after seeking addiction
ICD-10 code
f10-f11-f1
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance use

Primary outcomes

1

Description
Muscular pain
Timepoint
In the first days, 3rd, 6th and 9th treatments
Method of measurement
Based on the visual scale of pain

2

Description
Anxiety
Timepoint
In the first days, 3rd, 6th and 9th treatments
Method of measurement
Beck Test

Secondary outcomes

1

Description
Sex
Timepoint
First
Method of measurement
Identity Card

2

Description
age
Timepoint
first
Method of measurement
Identity Card

Intervention groups

1

Description
Intervention group: At the same time, with the onset of methadone, the intervention group will be prescribed a dropsy pumpkin that should be used until the signs of withdrawal and stabilization of the dose of methadone are consumed.
Category
Treatment - Drugs

2

Description
Control group: At the same time, with the onset of methadone, the control group will be prescribed piroxicam which should be used until the symptoms of withdrawal and stabilization of the dose of methadone are consumed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Behzist addiction Clinic
Full name of responsible person
Atefeh Asadi
Street address
Floor (-1), Deputy Medical Building, no. 15, Kashefialasl Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 51 4422 4519
Email
a.asadi.mm.1384@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh GHorat
Street address
Pardiss of University, Kousar street, toohid Blvd.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 21 4401 1035
Email
ghorat.f@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Nematshahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Central University, Asadabadi Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 51 4422 9180
Fax
Email
9151737407mn@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Nematshahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Central University, Asadabad Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 51 4422 9180
Fax
Email
9151737407mn@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Atefeh Asadi
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Health Service Management
Street address
Department of Health, Taleghani street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 51 4422 9180
Fax
Email
a.asadi.mm.1384@gmail.com
Web page address

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
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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