Evaluating the effect of Crocus sativus L. (Saffron) on appetite and weight of subjects with binge eating disorder: A randomized, double-blind, placebo-controlled clinical trial
Evaluating the effect of Crocus sativus L. (Saffron) on appetite and weight of subjects with binge eating disorder
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
This study will be performed on patients attending Imam Khomeini Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals with binge eating disorder confirmed by the SCID-V semi-structured questionnaire - No specific diet - Normal physical activity - No drug or non-drug treatment. Exclusion criteria: Diabetes - Cancer - Drug addiction - Thyroid dysfunction - Drugs effective in appetite and weight - Taking psychiatric drugs - Stomach surgery or taking food supplements - Diagnosis of other eating disorders.
Intervention groups
Control group: patients take placebo capsules twice a day - Intervention group: patients take saffron capsules with a dose of 15 mg twice a day.
Main outcome variables
The severity of binge eating disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N149
Registration date:2023-04-04, 1402/01/15
Registration timing:prospective
Last update:2023-04-04, 1402/01/15
Update count:0
Registration date
2023-04-04, 1402/01/15
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Crocus sativus L. (Saffron) on appetite and weight of subjects with binge eating disorder: A randomized, double-blind, placebo-controlled clinical trial
Public title
The effect of saffron on binge eating disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with binge eating disorder confirmed by the SCID-V semi-structured questionnaire
No specific diet
Normal physical activity
No drug or non-drug treatment
Exclusion criteria:
Diabetes
Cancer
Drug addiction
Thyroid dysfunction
Drugs effective in appetite and weight
Taking psychiatric drugs
Stomach surgery or taking food supplements
Diagnosis of other eating disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups).
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Medicine, Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-01-02, 1401/10/12
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.454
Health conditions studied
1
Description of health condition studied
The severity of binge eating disorder
ICD-10 code
F50.02
ICD-10 code description
Anorexia nervosa, binge eating/purging type
Primary outcomes
1
Description
The severity of binge eating disorder
Timepoint
Baseline, and weeks 4, 8, 12
Method of measurement
By SCID-V semi-structured questionnaire - DASS-21 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: patients take placebo capsules twice a day for three months.
Category
Placebo
2
Description
Intervention group: patients take saffron capsules with a dose of 15 mg twice a day for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Dr. Mohammad Reza Mohammadi
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
mohammadimr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 5541 2222
Email
afotouhi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
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
No - There is not a plan to make this available
Title and more details about the data/document
The data will be distributed through final report
When the data will become available and for how long
5 years from 2023 to 2028
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Users should cite the resource of data
From where data/document is obtainable
Prof. Shahin Akhondzadeh
What processes are involved for a request to access data/document