Protocol summary

Study aim
Investigating the effect of saffron extract on oxidative stress, sexual dysfunction, measurement of sex hormones, prolactin and sperm parameters in the group of opioid-dependent men undergoing maintenance treatment with methadone, opium tincture and voluntary withdrawal
Design
A parallel clinical trial with a randomized control group. SPSS 26 software
Settings and conduct
De-addiction clinic centers in Semnan (Saba and Hayat) and People staying in Mehdi Shahr drug addiction camp
Participants/Inclusion and exclusion criteria
Entry:Consciously married men, without coercion, with literacy.Use of opioid substances for at least 5 years and receiving methadone and opium tincture for at least 1 year. sexual disorders with the minimum score of sexual problems Non-entry: severe anxiety disorders, depression, suicidal thoughts and withdrawal, autism, mental retardation, psychosis, bipolar and cardiovascular diseases, kidney, liver, thyroid, diabetes, digestive diseases, blood pressure, cancer diseases, AIDS
Intervention groups
group, in addition to receiving methadone maintenance treatment, tincture, and the group staying in the camp, took oral tablets of saffron extract 50 mg/day every morning for 12 weeks, and the second group, in addition to receiving methadone maintenance treatment, tincture, and staying in the camp, placebo tablets (control group) ) consume Before the intervention of saffron tablets and 1 day after taking the last received dose, filling out questionnaires, taking sperm samples and taking blood from patients to determine the evaluation of parameters. After the statistical analysis of the data in the groups, a follow-up (sexual function questionnaire) is completed by the patient after 1 month
Main outcome variables
Improve sexual performance Improving the quality of sexual life Reducing relapse and craving for drug use

General information

Reason for update
Acronym
عصاره زعفران- ختلال عملکرد جنسی-متادون، تنتور اوپیوم - ترک اختیاری
IRCT registration information
IRCT registration number: IRCT20240311061254N1
Registration date: 2024-04-14, 1403/01/26
Registration timing: prospective

Last update: 2024-04-14, 1403/01/26
Update count: 0
Registration date
2024-04-14, 1403/01/26
Registrant information
Name
Mehrana Mehranpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3105 2124
Email address
m.mehranpoor@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
2024-06-21, 1403/04/01
Actual recruitment end date
2024-09-22, 1403/07/01
Trial completion date
2024-10-22, 1403/08/01
Scientific title
Effect of saffron (Crocus sativus L.) extract on oxidative stress, sex hormones and sexual dysfunction in opioid-dependent men undergoing methadone, opium tincture maintenance treatment and voluntary abstinence
Public title
Investigating the effect of saffron extract on sex hormones and sexual dysfunction in opioid-dependent men undergoing maintenance treatment with methadone, opium tincture and voluntary withdrawal
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
The entry of married men knowingly, without coercion and freely, who are literate and literate, will participate in this study by filling and signing a written consent form, and they are psychologically and cognitively healthy, aware and alert. Active use of opioid substances for at least 5 years before the study and people receiving methadone or opium tincture have been under maintenance treatment with methadone or opium tincture for at least 1 year. According to the sexual disorders questionnaire, have sexual problems with a minimum score (average). Patients' evaluation: all the relevant information will be available in accordance with the ethical principles in maintaining and trusting the identity of the patients. 1- Personal characteristics: name, surname, father's name, ID number, place of birth, date of birth 2- Basic demographic characteristics: gender, marital status, level of education, occupation, weight, height, level of physical activity, race (native or not) 3- The type of narcotic used by the patients 4- Determining the dosage and duration of the narcotic in the past months 5- Examining the previous treatment history of the patients in the field of addiction, including outpatient methods, hospitalization, self-medication, staying in camps and camps etc. 6- History of sexual problems, including late or early ejaculation, dysfunction of erectile function, decreased sexual desire, sexual behavior problems, general dissatisfaction with sexual relations 7- History of prison 8- History of physical and special diseases
Exclusion criteria:
All patients who have severe anxiety, depression, stress, mental disorders (suicidal thoughts and withdrawal, dementia, autism, mental retardation, psychosis, bipolar disease, etc.) and have cardiovascular, kidney, liver, lung, thyroid, diabetes, Gastrointestinal diseases, blood pressure, all types of cancer and infectious diseases and AIDS, and they also have drug sensitivity, plant allergies, autoimmune diseases, sexual problems and congenital reproductive system, and taking medicine is harmful for them. They have absolute prohibition conditions.
Age
From 25 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 240
More than 1 sample in each individual
Number of samples in each individual: 40
There are 30 people in each group (180 people in total). With an estimate of 25% attrition, we first include 40 people in each group who are eligible to enter the study.
Actual sample size reached: 180
More than 1 sample in each individual
Actual sample size in each individual: 30
We include 30 people in each group.
Randomization (investigator's opinion)
Randomized
Randomization description
There are 30 people in each group (180 people in total). With an estimate of 25% attrition, we first include 40 people in each group who are eligible to enter the study. Because the work will be done in several stages, we will use the information of the initial stages to estimate the exact sample size and continue the study until reaching that number of samples, and they will be divided into two groups using blocks of four.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Investigating the sexual dysfunction of opioid-dependent patients that saffron extract can improve sexual function and improve the quality of their sexual life.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
IR.SEMUMS.REC
Street address
Five kilometers from Damghan road - Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3513138111
Approval date
2024-03-12, 1402/12/22
Ethics committee reference number
1402.302

Health conditions studied

1

Description of health condition studied
Opioid dependent men undergoing maintenance treatment with methadone, opium tincture and voluntary withdrawal
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Investigation of saffron extract on sexual dysfunction in opioid-dependent men undergoing maintenance treatment with methadone, opium tincture and voluntary withdrawal
Timepoint
Before the intervention of saffron tablets and 1 day after taking the last dose, questionnaires will be filled, sperm sampling and blood sampling will be done to determine the evaluation of the desired parameters. After the statistical analysis of the data in the relevant groups, if the saffron extract is effective after 1 month to ensure the durability of the effect of saffron on sexual function, the sexual disorders questionnaire will be completed by the patients in the form of follow-up and support.
Method of measurement
Investigation of sexual disorders based on questionnaire

Secondary outcomes

1

Description
Investigating saffron extract on oxidative stress, sex hormones, sperm parameters and craving intensity in opioid dependent men undergoing maintenance treatment with methadone, opium tincture and voluntary withdrawal
Timepoint
Before the intervention of saffron tablets and 1 day after taking the last dose, questionnaires, sperm sampling and blood sampling of patients will be done to determine the evaluation of the desired parameters. After the statistical analysis of the data in the relevant groups, if the saffron extract is effective after 1 month to ensure the durability of the effect of saffron on sexual function, the sexual disorders questionnaire will be completed by the patients in the form of follow-up and support.
Method of measurement
Investigating oxidative stress, sex hormones through blood sampling and sperm samples through marital relationships and severity of addiction and craving based on questionnaires

Intervention groups

1

Description
Intervention group: Intervention group: under maintenance treatment with methadone and opium ventor and voluntary withdrawal who are taking saffron extract tablets.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Saba and Hayat Clinic
Full name of responsible person
Asadi
Street address
Five kilometers from Damghan road - Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 912 131 6936
Email
m.mehranpoor@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Hosseinzadeh
Street address
Mashhad Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
3513138111
Phone
+98 915 116 4156
Email
hosseinzadehh@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
50
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
Semnan University of Medical Sciences
Full name of responsible person
Hossein Miladi Georgi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Five kilometers from Damghan Road - Semnan Medical School
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 912 531 3069
Email
miladi331@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hossein Miladi Georgi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Five kilometers from Damghan Road - Semnan Medical School
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 912 531 3069
Email
miladi331@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
mehrana mehranpour
Position
PHD student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Semnan Medical School
City
Semnan
Province
Semnan
Postal code
3013138111
Phone
+98 904 630 5483
Email
m.mehranpoor@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
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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