Protocol summary

Summary
This study will be designe to evaluate the efficacy of administration of Hab-o Shefa during 21 days in the management of acute opioid withdrawal. A total of 90 treatment-seeking opioid dependents will be admitted and randomly assigned to three groups(placebo, Hab-o Shefa and clonidine groups) in a double blind, cotroled trial, using a computer-generated list of random numbers. The study will be conducted from Ceptember of 2011 through December of 2011 on the addiction center Tavalod-e Dobare (the major addiction center affiliated with Welfare Organization, Iran). They will be evaluated prior to admission with ECG and medical history and physical examination and will be assessed after admission with Laboratory tests including CBC, FBS, TG, Chole, AST, ALT, BUN, Crea, Na, K. Common study design for 3 groups included; 1th day each patients receive one purple capsule (cap) and four pink capsules (caps), 2th day receive 2 purple caps and 4 pink caps, 3th - 7th days receive 3 purple and 4 pink caps in four divided doses, 8th – 11th days receive 3 purple and 3 pink caps, 12th – 18th days 3 purple and 2 pink caps, 19th day 2 purple and 1 pink caps, 20th day 1 purple and 1 pink caps. For placebo group all caps contains sugar, for Hab-o Shefa group pink caps; each cap contain 750 mg Hab-o Shefa and purple caps contain sugar, for clonidine group purple caps; each cap contain 0.2 mg clonidine and pink caps contain sugar. Variables that will be checked daily by the investigator and recorded in forms included retention in treatment, rates of successful detoxification, the Subjective Opiate Withdrawal Scale (SOWS) scores, the Objective Opiate Withdrawal Scale (OOWS) scores, Clinical opioid withdrawal Scale (Cows) Scores, intensity of craving, depression Bek, depression Hamilton, drug side effects. The rater, a fourth year resident of Traditional Iranian Medicine (TIM) who will be trained in the use of the scales and will be blind to treatment group. All subjects will be given informed written consent prior to admission. Subjects can withdraw their participation at any time and transfer to a conventional detoxification treatment. The study will be conducted in accordance with the Declaration of Helsinki and was approved by the ethical committee at Shahed University and research steering committee at Shahed University of Medical Sciences.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109107518N1
Registration date: 2012-03-16, 1390/12/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-03-16, 1390/12/26
Registrant information
Name
Seyed mohammad Nazari
Name of organization / entity
Shahed university
Country
Iran (Islamic Republic of)
Phone
+98 21 6648 2491
Email address
smnazari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University, Research Affairs
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation of effect of Hab-o-Shefa in control of withdrawal symptoms in treatment of opioid addiction to acute detoxification.
Public title
The investigation of effect of Hab-o Shefa in control of withdrawal symptoms in opioid addicts.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Opioids addiction according to DSM IV; Age between 25 to 40 years old; male; Posittive urinary morphine testو Exclusion criteria: Addiction to stimulants or alchole; Acute incontrollable to physical disease; antisocial or borderline personality or inability to answer questionnaire; Not patient consent for the study; Severe withdrawal symptoms or complications and drug allergies; Beginning of the study positive urinary stimulants test or negative urinary morphine test
Age
From 25 years old to 40 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
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
The university shahed of Ethics committee
Street address
Shahed university, opposite of holy senctury imam khomaini, Tehran-Qom highway, Tehran
City
Tehran
Postal code
Approval date
2011-09-11, 1390/06/20
Ethics committee reference number
118967

Health conditions studied

1

Description of health condition studied
Opioid addiction
ICD-10 code
f11.2
ICD-10 code description
Mental and behavioural disorders due to use of opioids

Primary outcomes

1

Description
Clinical withdrawal symptoms
Timepoint
Daily
Method of measurement
questionair according to DSM IV

2

Description
Objective withdrawal symptoms
Timepoint
Daily
Method of measurement
questionair according to DSM IV

3

Description
Subjective withdrawal symptoms
Timepoint
Daily
Method of measurement
questionair according DSM IV

4

Description
Depression Bek
Timepoint
Daily
Method of measurement
Bek questionaire

5

Description
Depression Hamilton
Timepoint
Daily
Method of measurement
Hamilton questionair

6

Description
craving on opioids
Timepoint
Daily
Method of measurement
Halikas questionaire

Secondary outcomes

1

Description
Adverse effect of Hab-o-Shefa and Clonidine
Timepoint
Daily
Method of measurement
Accordingto Traditional Iranian Medicine refrences and textbook of Katzong: tachicardic arrythmia, Blurred vision, Changes in vision- photophobia, constipation, urinary disorder, vertigo, Sleep disorders, Dry mouth, nausea and vomitting, flashing

Intervention groups

1

Description
Clonidine is a specific a2-adrenergic receptor agonist that has been widely used in opioid detoxification. Treatment program in this study included the first day 0/2 mg and 2th days 0/4 mg and 3th days until 18th days 0/6mg and tapering down until 20th days and then stops.
Category
Treatment - Drugs

2

Description
Hab-o Shefa is a combination drug of Traditional Iranian Medicine that it is combination of different ratios of datura stramonium, Rheum Palmatum, Zingiber Officionalis and Acacia Arabica. This is a combined oral with daily dose of 3 g. This combination is available in capsules of 500 mg and 750 mg per capsule. Treatment program in this study included the first day four capsules daily for seven days and 3 capsules daily for eighth until eleventh days and one capsule until twentieth day and then stops.
Category
Treatment - Drugs

3

Description
In this study sugar is used as a placebo.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical center of Tavalod-e-Dobare
Full name of responsible person
Hasani Reza
Street address
Treatment Addiction centers of Tavalod-dobare, opposite to Metro entrances, mohamad shahr, karaj
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Studies and Research afair of University shahed.
Full name of responsible person
Dr. Mohammadreza jalali
Street address
Shahed university, Opposite to holy shrine of Imam Khomaini, Highway Tehran-Qom, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Studies and Research afair of University shahed.
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
Medicine callege of Shahed University
Full name of responsible person
seyed mohammad nazari
Position
Final year Resident of Traditional Iranian Medicine
Other areas of specialty/work
Street address
Medicine callege, Bolvare Keshavarz, Abdollah zade street,
City
Tehran
Postal code
Phone
+98 912 808 7714
Fax
Email
drnazari43@gmail.com shamidrezanazari@yahoo.com timshahed@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Traditional Iranian Medicine Groups of Shahed University
Full name of responsible person
seyed mohammad nazari
Position
final year resident of Traditional Iranian Medicine
Other areas of specialty/work
Street address
Shahed medicine callage, Bolvar-e Keshavarz, Abdollah zade street
City
Tehran
Postal code
Phone
+98 21 2288 2521
Fax
Email
drnazari43@gmail.com shamidrezanazari@yahoo.com timshahed@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University School of Medicine of Shahed
Full name of responsible person
seyed mohammad nazari
Position
final year resident of Traditional Iranian Medicine
Other areas of specialty/work
Street address
Medicine college, Abdullah Zadeh street, Farmer's Boulevard, Tehran
City
Tehran
Postal code
Phone
Fax
Email
drnazari43@gmail.com shamidrezanazari@yahoo.com timshahed@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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