1. Home
  2. Approved trials
  3. » فارسی

A Clinical trial to assess the effect of crocin supplementation compared with the placebo on mental health parameters, metabolic profiles and genetic response in methadone maintenance treatment patients

View the latest revision

History
# Registration date Revision Id
2 2019-09-14, 1398/06/23 103668
1 2018-12-31, 1397/10/10 73269
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
    Clinical trial with control group, parallel groups, double-blind (both patients and researchers), randomized, 60 patients, phase 2
    طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، دو سویه کور (هم بیماران و هم محققان)، تصادفی شده، 60 بیمار، فاز 2
    Inclusion criteria: Patients on methadone maintenance treatment and aged 18 to 60 years will be included in this study. Exclusion criteria: Unwillingness to cooperate.
    Inclusion criteria: Patients on methadone maintenance treatment and aged 18 to 60 years, Beck Depression Scores > 20 and Beck Anxiety > 15 will be included in this study. Exclusion criteria: Taking crocin, anti‐inflammatory and antioxidant supplements during the last 3 months before the intervention, history of metabolic diseases including diabetes, hypertension, thyroid, and cardiovascular disease.
    معیار ورود به مطالعه: بیماران تحت درمان نگهدارنده با متادون در محدوده سنی 18 تا 60 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد.
    معیار ورود به مطالعه: بیماران تحت درمان نگهدارنده با متادون در محدوده سنی 18 تا 60 سال، نمرات افسردگی بک بیشتر از 20 و اضطراب بک بیشتر از 15 وارد مطالعه خواهند شد. معیار خروج از مطالعه: گرفتن مکمل های کروسین، ضد التهابی و آنتی اکسیدانت در طی سه ماه قبل از مداخله گرفتن، سابقه بیماری متابولیک از قبیل دیابت، فشار خون، تیروئید و بیماری قلبی عروقی.
    Mental health parameters (primary outcome), metabolic profiles and genetic response (secondary outcome) will be quantified at study baseline and end-of-trial.
    Mental health parameters (primary outcome), metabolic profiles and genetic response (secondary outcome)
    پارامترهای سلامت روان (پیامد اولیه)، پروفایل های متابولیک و پاسخ ژنتیکی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
    پارامترهای سلامت روان (پیامد اولیه)، پروفایل های متابولیک و پاسخ ژنتیکی (پیامدهای ثانویه)

  • General information

    Patients on methadone maintenance treatment
    Age of 18 to 60 years old
    Currently undergoing MMT and opioid dependence in the past year
    Age of 18 to 60 years old
    Evaluated by the drug abuse section of the Structured Clinical Interview for DSM‐IV
    Beck Depression Scores > 20 and Beck Anxiety > 15
    Seeking for treatment
    بیماران تحت درمان نگهدارنده با متادون
    محدوده سنی 18 تا 60 سال
    بیماران در حال حاضر تحت درمان نگهدارنده با متادون و وابستگی به اپیوئید در یک سال گذشته باشند.
    محدوده سنی 18 تا 60 سال
    ارزیابی از طریق راهنمای تشخیصی و آماری اختلال‌های روانی یا DSM‐IV
    نمرات افسردگی بک بیشتر از 20 و اضطراب بک بیشتر از 15
    به دنبال درمان باشد.
    Unwillingness to cooperate
    Taking crocin, anti‐inflammatory and antioxidant supplements during the last 3 months before the intervention.
    History of metabolic diseases including diabetes, hypertension, thyroid, and cardiovascular disease.
    عدم تمایل به همکاری
    گرفتن مکمل های کروسین، ضد التهابی و آنتی اکسیدانت در طی سه ماه قبل از مداخله گرفتن
    سابقه بیماری متابولیک از قبیل دیابت، فشار خون، تیروئید و بیماری قلبی عروقی
    To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<40 and ≥40 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
    Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups. .
    برای کاهش اثرات مخدوش کنندگی بالقوه، همه شرکت کنندگان بر اساس نمایه توده بدنی (<25 و ≥25 کیلوگرم بر متر مربع) و سن (<40 و ≥40) تصادفی سازی لایه ای خواهند شد. سپس، افراد در هر بلوک به طور تصادفی به دو گروه برای دریافت مکمل یاری یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار کامپیوتری انجام خواهد شد.
    نحوه تصادفی سازی با روش ساده و استفاده از اعداد تصادفی ایجاد شده توسط نرم افزار کامپیوتری (نرم افزار Stat Trek) انجام خواهد شد. در اين روش كامپيوتر اعداد تصادفي انتخاب مي كند. با در نظرگرفتن اعداد براي دو گروه تصادف سازي انجام مي گيرد.
    Placebo has been used to achieve masking of participants and investigators. The researchers and patients will be concealed until the final analyses by a trained staff.
    Placebo will be used to achieve participants and investigators masking. The researchers and patients will be concealed until the final analyses by a trained staff.
    از پلاسبو برای کور سازی استفاده شده است. محققان و بیماران کور تا زمان آنالیز نهایی توسط یک کارمند آموزش دیده خواهند شد.
    از پلاسبو برای کور سازی استفاده شده است. محققان و بیماران تا زمان آنالیز نهایی توسط یک کارمند آموزش دیده کور نگاه داشته خواهند شد.

  • Primary outcomes

    #1
    Sleep quality
    empty
    کیفیت خواب
    empty
    At the beginning of the study and after 8 weeks of intervention
    empty
    در ابتدای مطالعه و 8 هفته بعد از مداخله
    empty
    Questionnaire(PSQI)
    empty
    پرسشنامه (PSQI)
    empty

Protocol summary

Study aim
The aim of this study is to determine the effects of crocin supplementation on mental health parameters, metabolic profiles and genetic response in methadone maintenance treatment patients
Design
Clinical trial with control group, parallel groups, double-blind (both patients and researchers), randomized, 60 patients, phase 2
Settings and conduct
Population and sample size: 60 eligible patients on methadone maintenance treatment referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients on methadone maintenance treatment and aged 18 to 60 years, Beck Depression Scores > 20 and Beck Anxiety > 15 will be included in this study. Exclusion criteria: Taking crocin, anti‐inflammatory and antioxidant supplements during the last 3 months before the intervention, history of metabolic diseases including diabetes, hypertension, thyroid, and cardiovascular disease.
Intervention groups
Intervention: Patients will be assigned to receive either crocin (n=30) or placebo (n=30).
Main outcome variables
Mental health parameters (primary outcome), metabolic profiles and genetic response (secondary outcome)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170420033551N4
Registration date: 2018-12-31, 1397/10/10
Registration timing: registered_while_recruiting

Last update: 2019-09-15, 1398/06/24
Update count: 1
Registration date
2018-12-31, 1397/10/10
Registrant information
Name
Amir Ghaderi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 771 7435
Email address
ghaderi-am@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-13, 1397/09/22
Expected recruitment end date
2019-01-12, 1397/10/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trial to assess the effect of crocin supplementation compared with the placebo on mental health parameters, metabolic profiles and genetic response in methadone maintenance treatment patients
Public title
Effect of crocin supplementation in treatment of methadone maintenance treatment patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Currently undergoing MMT and opioid dependence in the past year Age of 18 to 60 years old Evaluated by the drug abuse section of the Structured Clinical Interview for DSM‐IV Beck Depression Scores > 20 and Beck Anxiety > 15 Seeking for treatment
Exclusion criteria:
Taking crocin, anti‐inflammatory and antioxidant supplements during the last 3 months before the intervention. History of metabolic diseases including diabetes, hypertension, thyroid, and cardiovascular disease.
Age
From 18 years old to 60 years old
Gender
Male
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups. .
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo will be used to achieve participants and investigators masking. The researchers and patients will be concealed until the final analyses by a trained staff.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Approval date
2018-12-11, 1397/09/20
Ethics committee reference number
IR.KAUMS.REC.1397.006

Health conditions studied

1

Description of health condition studied
Addiction
ICD-10 code
F19
ICD-10 code description
Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances

Primary outcomes

1

Description
Depression beck score
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Questionnaire

2

Description
Anxiety beck score
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Total antioxidant
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry

2

Description
HDL
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit

3

Description
Total cholesterol
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit

4

Description
Triglycerides
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit

5

Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit

6

Description
Insulin
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Elisa kit

7

Description
Nitric oxide
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry

8

Description
Hs-CRP
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Elisa kit

9

Description
Expressed levels of LL-1 gene
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
PCR

10

Description
Expressed levels of TNF-a gene
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
PCR

11

Description
Expressed levels of PPAR-γ
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
PCR

12

Description
Total glutathione
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
Spectrophotometry

13

Description
Malondialdehyde
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
Spectrophotometry

14

Description
Expressed levels of TGF-β gene
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
PCR

15

Description
Expressed levels of LDLR gene
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
PCR

Intervention groups

1

Description
Intervention group: tablet of Crocin, 15 mg, two oral tablet for 8 weeks.
Category
Treatment - Drugs

2

Description
Control group: Placebo tablet, two oral tablet for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Gholabchi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 4455 2200
Email
asemi_r@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 2999
Email
banafshe57@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0021
Email
asemi_z@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0021
Email
asemi_z@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0021
Email
asemi_z@kaums.ac.ir

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
No - There is not a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...