The effect of crocin on weight gain in patients taking clozapine
Design
This study is a double-blind, randomized, placebo-controlled clinical trial. In this study, using purposive sampling method, 74 patients taking antipsychotic drugs admitted to Hejazi Hospital in Mashhad, who take clozapine for at least one month with the prescription of a psychiatrist, after completing the informed consent form of guardian or legal guardian and The patient himself will enter the study. Patients will then be randomly assigned to one of the drug or placebo groups (37 in each group)
Settings and conduct
The place of this research is Dr. Hejazi Psychiatric Hospital in Mashhad. It is a two-way blind study in which the people under study and evaluators are blind and the blinding is done by sealed envelopes
Participants/Inclusion and exclusion criteria
Admission requirements:
1) Patients taking clozapine who at least one month before the start of the study with a BMI greater than 25 or weight gain greater than 10%
(2) Age range 20 to 60 years
(3) Satisfaction of the patient and his guardian for the company
Conditions of non-entry:
(1) No entry of schizoaffective and bipolar patients
(2) Non-pregnancy and lactation
(3) Do not enter patients who are taking drugs that affect weight at the same time
(4) Do not admit patients who are addicted to drugs, stimulants and alcohol
(5) Lack of untreated medical condition affecting weight such as hypothyroidism
(6) Dissatisfaction of the patient or her guardian to participate in the study
Intervention groups
Intervention group: Taking crocin 15 mg tablets twice a day for 8 weeks
Control group: placebo tablets are prescribed twice a day for 8 weeks with appearance and protocol
Main outcome variables
Weight; Waist size and BMI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211202053250N2
Registration date:2022-07-24, 1401/05/02
Registration timing:registered_while_recruiting
Last update:2022-07-24, 1401/05/02
Update count:0
Registration date
2022-07-24, 1401/05/02
Registrant information
Name
Mahboubeh eslamzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2721
Email address
eslamzadehmh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-20, 1401/03/30
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of crocin on weight gain in patients taking clozapine
Public title
The effect of crocin on weight gain in patients taking clozapine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients taking clozapine for at least one month before the start of the study with a BMI greater than 25 or weight gain greater than 10%
Age range 20 to 60 years
Patient and guardian consent to participate in the study
No entry of schizoaffective and bipolar patients
No history of allergies to crocin
No pregnancy and lactation
Do not admit patients who are taking drugs that affect weight at the same time
Do not admit patients who are addicted to drugs, stimulants and alcohol
Lack of untreated medical condition affecting weight such as hypothyroidism
Exclusion criteria:
No patient entering below the age range of 20 years and above 60 years
No entry of schizoaffective and bipolar patients
Absence of pregnancy and lactation
Do not admit patients who are taking drugs that affect weight at the same time
Do not admit patients who are addicted to drugs, stimulants and alcohol
Lack of untreated medical condition affecting weight such as hypothyroidism
Patient dissatisfaction to participate in the study
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization will be done using the random block method. By using www.randomizer.org, randomization will be done using random blocks. In the optimization part, the list of random numbers will be generated as 37 blocks of 2. Based on that, people will be randomly assigned to one of the intervention and control groups using a sealed envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, blinding will be done in relation to the participants in the research, researcher and data evaluator. The form of drugs and placebos is exactly the same, so the patient will not know the type of intervention. Also, the treating physician will not know the type of intervention. Therefore, the study will be conducted blindly. To evaluate the data, groups will be assigned a number instead of a name, so that the course can be evaluated
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ibn Sina Psychiatric Hospital, Hore ameli Blvd, Ferdowsi Squaree
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Approval date
2022-05-15, 1401/02/25
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.083
Health conditions studied
1
Description of health condition studied
Weight gain
ICD-10 code
E66.9
ICD-10 code description
Simple obesity NOS
Primary outcomes
1
Description
Weight
Timepoint
It is measured in patients at time zero and at the end of weeks 4 and 8
Method of measurement
Balance
2
Description
Waist size
Timepoint
It is measured in patients at time zero and at the end of weeks 4 and 8
Method of measurement
centimeter
3
Description
Positive and negative symptoms of schizophrenia
Timepoint
It is measured in patients at time zero and at the end of weeks 4 and 8
Method of measurement
PANSS Test
4
Description
Body Mass Index
Timepoint
It is measured in patients at time zero and at the end of weeks 4 and 8
Method of measurement
Height to weight ratio
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Taking 15 mg crocin tablets twice a day for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Placebo tablets are prescribed twice a day for 8 weeks with appearance and protocol
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn-Sina Hospital
Full name of responsible person
Mahboubeh Eslamzadeh
Street address
Ibn Sina Psychiatric Hospital, Hor Ameli Blvd. Ferdowsi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3700 2202
Email
eslamzadehmh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mubarhan
Street address
Ghoreshi department, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Email
presidentoffice@mums.ac.ir
Grant name
Vice Chancellor for Research, Mashhad University of Medical Sciences
Grant code / Reference number
991936
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
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
Mashhad University of Medical Sciences
Full name of responsible person
Mahboubeh Eslamzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sina Psychiatric Hospital, Hore Ameli Boulvared. Ferdowsi Square Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3700 2202
Email
EslamZadehMH@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahboubeh Eslamzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sina Psychiatric Hospital, Hore Ameli Boulvard. Ferdowsi Square Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3700 2202
Email
EslamZadehMH@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahboubeh Eslamzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sina Psychiatric,aHospital, Hore Ameli Booulvard. Ferdowsi Square Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3700 2202
Email
EslamZadehMH@mums.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