Protocol summary

Study aim
Determining the effect of rosemary on anxiety, depression, sexual disorders, sleep and cognitive disorders in patients undergoing maintenance treatment with methadone
Design
A clinical trial with 2 groups, with parallel groups (intervention group: recipient of rosemary capsules containing 500 mg of the active ingredient of rosemary, every 12 hours for 4 weeks, control group: recipient of a placebo with the same color, smell and appearance but the content of an ineffective substance like starch, but with a similar scent), double-blind, randomized, phase 2 on 52 patients. Randomization is done using a table of random numbers.
Settings and conduct
Place:addiction treatment clinic of Shahid Beheshti Hospital, Kerman, drugs are given to patients in similar capsules for 4 weeks. randomization and allocation remain hidden from the researchers and participants until the completion of the statistical analysis.
Participants/Inclusion and exclusion criteria
Age between 18 and 60 years Literacy for reading and writing Proficiency in Persian language Methadone maintenance treatment No history of heart disease No diabetes Absence of liver and kidney failure Absence of pregnancy Epilepsy and life-threatening diseases Lack of chronic treatment with antidepressants Not receiving antidepressants, benzodiazepines, melatonin and other sleep medications during the past month Not having moderate to severe mental disability No history of allergic reaction to rosemary and similar products
Intervention groups
Intervention group: receiving rosemary capsules containing 500 mg of the effective ingredient of rosemary, every 12 hours for 4 weeks. Control group: receiving a placebo with a similar color, smell and appearance, but containing an ineffective substance such as starch, but with a similar scent.
Main outcome variables
Anxiety, sexual disorders, cognitive disorder, sleep disorder and depression disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240429061589N1
Registration date: 2024-05-09, 1403/02/20
Registration timing: prospective

Last update: 2024-05-09, 1403/02/20
Update count: 0
Registration date
2024-05-09, 1403/02/20
Registrant information
Name
Marziyeh Heidarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 420 5054
Email address
mim.heidarzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-04, 1403/03/15
Expected recruitment end date
2025-04-04, 1404/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating of the the effect of Rosmarinus officinalis L.on anxiety, depression, sexual dysfunction sleep disorder and cognitive disorders in patients undergoing maintenance treatment with methadone, double-blind, with placebo-controlled trial
Public title
Investigating the effect of rosemary on anxiety, depression, sexual disorders, sleep and cognitive disorders of patients undergoing maintenance treatment with methadone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 60 years Proficiency in Persian language Literacy for reading and writing Methadone maintenance treatment
Exclusion criteria:
No history of heart disease No diabetes Absence of liver and kidney failure Absence of pregnancy Epilepsy and life-threatening diseases Lack of chronic treatment with antidepressants Not receiving antidepressants, benzodiazepines, melatonin and other sleep medications during the past month Not having moderate to severe mental disability No history of allergic reaction to rosemary and similar products
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
The study samples will be blinded in a two-way and randomly using a table of random numbers in one of two groups of 26 people receiving medicine or placebo. For randomization, people will be divided into two groups based on the order of even and odd numbers. It is divided and the placebo is given to the executive by the project partner and it is recorded and specified for the project partner.
Blinding (investigator's opinion)
Double blinded
Blinding description
The placebo is given to the executive by the project partner and is recorded and specified for the project partner. In this study, randomization and allocation remain hidden from the researchers and participants until the completion of the statistical analysis, so the researchers and participants in this study are blinded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Afzalipour Hospital- Kerman University of Medical Sciences
Street address
Imam Khomeini Highway, Afzalipur Hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Approval date
2024-04-28, 1403/02/09
Ethics committee reference number
IR.KMU.AH.REC.1403.021

Health conditions studied

1

Description of health condition studied
drug abuse
ICD-10 code
F11
ICD-10 code description
Opioid related disorders

2

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

3

Description of health condition studied
depression
ICD-10 code
F32.9
ICD-10 code description
Major depressive disorder, single episode, unspecified

4

Description of health condition studied
sexual dysfunction
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction not due to a substance or known physiological condition

5

Description of health condition studied
Sleep disorder
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified

6

Description of health condition studied
Cognitive disorders
ICD-10 code
F11.7
ICD-10 code description
Mental and behavioural disorders due to use of opioids : residual and late-onset psychotic disorder

Primary outcomes

1

Description
Anxiety
Timepoint
Immediately before the beginning of the study and after the end of the intervention (fourth week)
Method of measurement
Hospital Anxiety and Depression Scale (HADS)

2

Description
Sexual disorders
Timepoint
Immediately before the beginning of the study and after the end of the intervention (fourth week)
Method of measurement
changes in sexual functioning questionnaire (csfq-14)

3

Description
Cognitive impairment
Timepoint
immediately before the beginning of the study and after the end of the intervention (fourth week)
Method of measurement
Montreal Cognitive Assessment

4

Description
Sleep disorder
Timepoint
Immediately before the beginning of the study and after the end of the intervention (fourth week)
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)

5

Description
Depression disorder
Timepoint
immediately before the beginning of the study and after the end of the intervention (fourth week)
Method of measurement
Hospital Anxiety and Depression Scale (HADS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: recipients of rosemary capsules containing 500 mg of the effective ingredient of rosemary, every 12 hours for 4 weeks.
Category
Treatment - Drugs

2

Description
Control group: receiving a placebo with a similar color, smell and appearance, but containing an ineffective substance such as starch, but with a similar scent.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
payam salehi
Street address
Jomhori BLVD. Shahid Beheshti Hospital
City
Kerman
Province
Kerman
Postal code
7618833639
Phone
+98 34 3211 1398
Email
h_beheshti@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Ebn-e-Sina St.,Jahad Blvd.,Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
KMU_RESEARCH@YAHOO.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Marziyeh Heidarzadeh
Position
Psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Emamreza highway, afzalipoor town, galayol8, unit:5
City
Kerman
Province
Kerman
Postal code
7617911111
Phone
+98 915 420 5054
Fax
Email
mim.heidarzadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nabi Banazadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hospital, Jomhori Blvd., Kerman
City
Kerman
Province
Kerman
Postal code
7617911111
Phone
+98 34 3211 1398
Email
n_banazadeh@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Marziyeh Heidarzadeh
Position
Psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Emamreza highway, afzalipoor town, galayol8, unit:5
City
Kerman
Province
Kerman
Postal code
7617911111
Phone
+98 915 420 5054
Fax
Email
mim.heidarzadeh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the study, part of the information including the effect of dexmedetomidine drug infusion on hemodynamic changes and sedation after coronary artery bypass surgery in opium addicted patients, after de-identifying the individuals, was shared with those interested in health, treatment and research. will be
When the data will become available and for how long
6 months after data analysis
To whom data/document is available
Researchers in the field of health and treatment
Under which criteria data/document could be used
Part of the information included at the end of the study,
From where data/document is obtainable
Marzieh Heydarzadeh - Email
What processes are involved for a request to access data/document
Purpose of data access - request to e-mail
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