Evaluating the effectiveness and safety of rosemary (Rosmarinus officinalis L.) on cognitive impairments, and positive and negative symptoms in patients with chronic schizophrenia: double blind placebo-controlled randomized trial
The aim of this study is to evaluate the effectiveness and safety of rosemary (Rosmarinus officinalis L.) on cognitive impairments, and positive and negative symptoms in patients with chronic schizophrenia
Design
This study is a randomized, double-blind, controlled clinical trial with a parallel group design of 50 patients.
Settings and conduct
Patients are selected from Kerman Golestan Health Center. Participants and a physician are blinded with similar placebo and rosemary capsules
Participants/Inclusion and exclusion criteria
The inclusion criteria are hospitalized patients with chronic schizophrenia (6 months or more should be passed from illness commencement) based on DSM-V criteria, and having no significant change in medication or symptoms over the previous 2 months. Exclusion criteria are mental retardation, substance dependence, and history of significant medical illness, alterations in the received medications, and hypersensitivity reactions to rosemary.
Intervention groups
Powdered rosemary (Rosmarinus officinalis L.) (in intervention group) or starch as placebo (in control group) are administered as 750 mg capsule twice daily for four weeks.
Main outcome variables
علائم مثبت و منفی و عملکرد شناختی بیماران با پرسشنامه های Positive and Negative Syndrome Scale (PANSS) و (Screen for Cognitive Impairment in Psychiatry (SCIP در آغازو 4 هفته بعد از درمان سنجیده می شوند.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110310006026N13
Registration date:2024-04-17, 1403/01/29
Registration timing:prospective
Last update:2024-04-17, 1403/01/29
Update count:0
Registration date
2024-04-17, 1403/01/29
Registrant information
Name
Fatemeh Dabaghzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5034
Email address
dabaghzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness and safety of rosemary (Rosmarinus officinalis L.) on cognitive impairments, and positive and negative symptoms in patients with chronic schizophrenia: double blind placebo-controlled randomized trial
Public title
Evaluating the effectiveness and safety of rosemary (Rosmarinus officinalis L.) on cognitive impairments, and positive and negative symptoms in patients with chronic schizophrenia: double blind placebo-controlled randomized trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized patients with chronic schizophrenia (6 months or more should be passed from illness commencement) based on DSM-V criteria
Having no significant change in medication or symptoms over the previous 2 months
Exclusion criteria:
Mental retardation
Substance dependence
History of significant medical illness
Alterations in the received medications
Hypersensitivity reactions to rosemary
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization: The eligible participants are allocated to one of the two study groups (intervention or placebo) in a 1:1 ratio. Randomization is by block Randomization with a block size of four. Randomization is performed at individual level. For allocation concealment, a person (not involved in the trial) generates allocation sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and physician are blinded to intervention assignment. For blinding, rosemary and placebo capsules have the same shape, color and outer packaging.
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 Sciences
Street address
Beginning of Jahad Blvd., Tahmasebad Fourways
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2024-03-09, 1402/12/19
Ethics committee reference number
IR.KMU.REC.1402.452
Health conditions studied
1
Description of health condition studied
Chronic schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Cognitive functions
Timepoint
At baseline and 4 weeks after intervention
Method of measurement
Screen for Cognitive Impairment in Psychiatry (SCIP) questionnaire
2
Description
Positive and negative symptoms
Timepoint
At baseline and 4 weeks after intervention
Method of measurement
Positive and Negative Syndrome Scale (PANSS) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Powdered rosemary is administered as one 750 mg capsule twice daily for four weeks.
Category
Treatment - Drugs
2
Description
Control group: starch as placebo (in control group) is administered as one 750 mg capsule twice daily for four weeks.