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
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
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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 will be included in this study. Exclusion criteria: Unwillingness to cooperate.
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) will be quantified at study baseline and end-of-trial.
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:2018-12-31, 1397/10/10
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:
Patients on methadone maintenance treatment
Age of 18 to 60 years old
Exclusion criteria:
Unwillingness to cooperate
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
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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
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
3
Description
Sleep quality
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Questionnaire(PSQI)
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