Effectiveness of saffron on cognitive impairment in schizophrenic patients treated with electric shock in patients in Golestan Hospital, Ahvaz
Design
A placebo-controlled, parallel-group, double-blind, randomized clinical trial on 46 patients.
Settings and conduct
The study was conducted in a double-blind manner in the psychiatry department of Ahvaz Golestan Hospital. Patients are divided into two treatment groups with saffron capsules and a placebo (23 people in each group). Both groups will be given 6 to 8 bilateral ECT sessions (3 times a week) and one saffron capsule or placebo (30 mg capsule) every day after meals until the ECT sessions are completed.
Participants/Inclusion and exclusion criteria
Entry conditions: 18-60 years old; suffering from schizophrenia based on DSM-5 criteria; candidate for receiving bilateral electroshock therapy. Conditions of non-entry: suffering from epilepsy and other neurological disorders; Known coagulation disorders; dependence or abuse of alcohol and drugs in the last 6 months (except for nicotine and caffeine); history of saffron consumption from the previous 3 months, and patients who received ECT in the last 6 months.
Intervention groups
Saffron capsules will be administered 48 hours before the start of shock therapy. The case group will be given 6 to 8 bilateral ECT sessions (3 times a week) and one saffron capsule (30 mg capsule) every day after meals until the ECT sessions are completed. A placebo capsule (with the same appearance as the saffron capsule) ) will be one daily after a meal. Receiving the medicine will continue until the end of 6 to 8 sessions of bilateral shock therapy.
Main outcome variables
Psychological disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240416061505N1
Registration date:2024-04-30, 1403/02/11
Registration timing:prospective
Last update:2024-04-30, 1403/02/11
Update count:0
Registration date
2024-04-30, 1403/02/11
Registrant information
Name
Amir Mohammadi Roozbahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 5200
Email address
roozbahani.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of saffron on cognitive impairment in schizophrenic patients treated with electric shock in Golestan Ahvaz patients
Public title
Investigating the effect of saffron on cognitive impairment in schizophrenic patients treated with electric shock
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Schizophrenic disorder based on DSM-5 criteria
A candidate for receiving bilateral electroshock therapy
Minimum literacy
Ability to communicate verbally
Not suffering from mental disability or serious cognitive disorders
Exclusion criteria:
Epilepsy and other neurological disorders
Coagulation disorders
Dependence or abuse of alcohol and drugs in the last 6 months (except nicotine and caffeine)
History of saffron consumption since 3 months ago
History of drug sensitivity
Pregnancy and breastfeeding
Patients who had ECT at least in the 6 months
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with eligible criteria will be divided into case and placebo groups completely randomly using random block permutations. An online website (https://www.sealedenvelope.com) is used to generate a random list based on the desired sample size and block size of 4. After creating a list, each patient will be identified with a unique code throughout the study. 23 people are selected for the intervention group and 23 people for the placebo group. While the patients and the therapist do not know the type of medicine received, they are treated.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant, the researcher, and the treatment staff are kept blind, and the opaque capsules are adjusted by a nurse not related to the research.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan St.
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Approval date
2024-01-27, 1402/11/07
Ethics committee reference number
IR.AJUMS.REC.1402.578
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Psychological disorder
Timepoint
Before the start of the ECT and again 24 hours after the fourth session of ECT and 72 hours after the end of the ECT
Method of measurement
Mini–mental state examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Saffron capsules will be administered 48 hours before the start of shock therapy. The case group will be given 6 to 8 bilateral ECT sessions (3 times a week) and one saffron capsule (30 mg capsule) after meals until the ECT sessions are completed.
Category
Treatment - Drugs
2
Description
Control group: They will receive a placebo capsule (with the same appearance as a saffron capsule) once a day after food. Receiving the medicine will continue until the end of 6 to 8 sessions of bilateral shock therapy.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Amir Mohammadi Roozbahani
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan St.
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3314 0000
Email
Roozbahani.a@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoosh Zakerkish
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan St.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3314 0000
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Mohammadi Roozbahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychology
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan St.
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 1333 5200
Fax
Email
Roozbahani.a@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Mohammadi Roozbahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychology
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan St.
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 1333 5200
Fax
Email
Roozbahani.a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Mohammadi Roozbahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychology
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan St.
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 1333 5200
Fax
Email
Roozbahani.a@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available