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Therapeutic effect of saffron extract on negative, positive and general symptoms of schizophrenia in comparison with placebo in patients with chronic schizophrenia

Protocol summary

Study aim
The aim of study was to evaluate the effect of saffron in patients with schizophrenia on positive, negative and general symptoms of patients.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 in 40 patients. Randomization using a random number table
Settings and conduct
In this study, 40 patients with schizophrenia were admitted to Golestan Salamat Center in Kerman Based on structured clinical interview (DSM-V TR), sampling is first available and then patients are divided into two groups, placebo and intervention. a random sequence is created from the table of random numbers and then even numbers are given to the intervention group and odd numbers to the control group. Two-way blinding, participants and researchers will not know about the distribution of saffron extract capsules and placebo. A sealed opaque envelope is used to hide drugs and placebo. The envelopes will be prepared by a non-research person The study period is four weeks and during this period, in addition to saffron capsules and placebo, they are routinely treated. Questionnaires of Positive and Negative Symptoms Scale, Hamilton Depression Scale and Hamilton Anxiety Scale are completed at the beginning and end of the research.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Age between 18 and 65 years, schizophrenia according to DSM-V-TR criteria. Exclusion criteria: General medical problems (coronary artery disease, metabolic syndrome and neurological diseases), substance abuse, use of anti-platelet and herbal medicines, allergy to saffron.
Intervention groups
Intervention group: Treated with 15 mg capsule of saffron extract twice a day Placebo group: placebo similar to the saffron capsule twice a day Both groups receive routine treatments.
Main outcome variables
Negative Symptoms , Positive Symptoms and General Symptoms of Schizophrenia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210525051404N1
Registration date: 2021-08-10, 1400/05/19
Registration timing: prospective

Last update: 2021-08-10, 1400/05/19
Update count: 0
Registration date
2021-08-10, 1400/05/19
Registrant information
Name
Mahdi Hajirezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 0409
Email address
mahdi.hajirezaei43@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effect of saffron extract on negative, positive and general symptoms of schizophrenia in comparison with placebo in patients with chronic schizophrenia
Public title
Therapeutic effect of saffron extract in patients with chronic schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Schizophrenia according to the DSM-V-TR criteria stable symptoms Age between 18 and 65 years
Exclusion criteria:
General medical problems (including coronary artery disease, metabolic syndrome, and neurological diseases) Drug abuse Taking antiplatelet drugs Taking herbal medicines Sensitivity to saffron
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, sampling is available first and then eligible patients will be assigned to two groups by simple random sampling. For this purpose, first a random sequence will be created from the table of random numbers. Then the extracted even numbers will be assigned to the intervention group and the odd numbers will be assigned to the control group. This process will continue to reach the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is two-way blind so that the participants and the research physician will not be aware of the distribution of saffron and placebo extract capsules, which are similar in color, size, shape and smell to the main drug. To hide the drugs and placebo, they will be placed in a sealed matte envelope numbered in a row. Envelopes will be prepared by a non-research person
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman university of medical science
Street address
Shahid beheshti Hospital, Jomhori Blv
City
Kerman
Province
Kerman
Postal code
7618833639
Approval date
2021-05-23, 1400/03/02
Ethics committee reference number
IR.KMU.AH.REC.1400.036

Health conditions studied

1

Description of health condition studied
schizophernia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

Primary outcomes

1

Description
Negative symptoms of schizophernia
Timepoint
Beginning of research and end of research (fourth week)
Method of measurement
Positive and Negative Syndrome Scale

2

Description
Positive symptoms of schizophrenia
Timepoint
Beginning of research and end of research (fourth week)
Method of measurement
Positive and Negative Syndrome Scale

3

Description
General symptoms of schizophrenia
Timepoint
Beginning of research and end of research (fourth week)
Method of measurement
Positive and Negative Syndrome Scale

Secondary outcomes

1

Description
Symptoms of anxiety
Timepoint
Beginning of research and end of research (fourth week)
Method of measurement
Hamilton Anxiety Scale

2

Description
Symptoms of depression
Timepoint
Beginning of research and end of research (fourth week)
Method of measurement
Hamilton Depression Scale

Intervention groups

1

Description
Intervention group: Treated with 15 mg capsule of saffron extract twice a day with routine treatments
Category
Treatment - Drugs

2

Description
Control group: Placebo is prepared in the form of a capsule that is similar to the saffron capsule in terms of shape, weight and color, and two tablets are prescribed daily. In addition, routine treatments are performed.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Health Center
Full name of responsible person
Ghediseh Bani vaheb
Street address
Haft Bagh Alavi
City
kerman
Province
Kerman
Postal code
7635119895
Phone
+98 34 3322 0902
Email
golestan.salamat@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abbas Pardakhti
Street address
Somayeh Crossroads
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
VCR@KMU.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mahdi Haji Rezaei
Position
Resident of psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hospital, Jomhuri Blvd, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7618833639
Phone
+98 34 3211 0409
Email
mahdi_hajirezaei@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nabi Banna Zadeh Mahani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hospital, Jomhuri Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7618833639
Phone
+98 34 3211 0409
Email
n_banazadeh@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahdi Haji Rezaei
Position
Resident of Psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hospital, Jomhuri Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7618833639
Phone
+98 34 3211 0409
Email
mahdi_hajirezaei@yahoo.com

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
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the study, some information including the effect of saffron medicine in the treatment of schizophrenia symptoms, after identifying individuals, will be shared with health enthusiasts.
When the data will become available and for how long
2 months after data analysis
To whom data/document is available
Health researchers
Under which criteria data/document could be used
In order to use the results and during the written request
From where data/document is obtainable
Mahdi Haji Rezaei- Email
What processes are involved for a request to access data/document
The purpose of accessing data - requesting e-mail
Comments
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