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Effect of licorice (Glycyrrhiza glabra) versus placebo on increasing the efficiency of antipsychotics in women with chronic schizophrenia, a double-blind clinical trials

Protocol summary

Study aim
The aim of this study was to investigate the effect of adding licorice to the therapeutic drug of the female patients with schizophrenia.
Design
This study was a double-blind, controlled trial, 20 woman patients with schizophrenia were assigned in each group.For randomization, the permuted block randomization will be used with quadruple blocks, In order to apply the concealment in the randomization process, unique codes, which is generated by the software, will be used on the drug boxes.
Settings and conduct
All patients referred to Imam Khomeini Hospital of Ahvaz, Iran, were assigned randomly in one of the treatment regimens for 8 weeks,The patients should be in the active phase of the disease and met DSM-IV criteria for chronic schizophrenia
Participants/Inclusion and exclusion criteria
In this study, 20 woman patients with schizophrenia were assigned in each group . The patients should be in the active phase of the disease and The patients were within the age range of 18-60 years old and the drug regimen of risperidone (6 mg/day) and cetirizine (4 mg/day). Exclusion criteria included bipolar disorder, dysthymic disorder
Intervention groups
Intervention group: 20 women with schizophrenia (in active phase), each receive a daily dose of 380 milligrams of licorice tablets, risperidone (6 mg/day) and cetirizine (4 mg/day) for 8 weeks. Control group: 20 men and women with schizophrenia (in active phase), each receive a daily dose of 380 milligrams of placebo (containing lactose, cellulose and starch), which looks like to licorice tablets, risperidone (6 mg/day) and cetirizine (4 mg/day) for 8 weeks.
Main outcome variables
PANSS score (Positive and Negative Syndrome Scale)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20111105008013N2
Registration date: 2018-08-26, 1397/06/04
Registration timing: retrospective

Last update: 2018-08-26, 1397/06/04
Update count: 0
Registration date
2018-08-26, 1397/06/04
Registrant information
Name
Amir Siahpoosh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3334 2197
Email address
siahpoosh-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
2018-01-21, 1396/11/01
Actual recruitment end date
2018-02-19, 1396/11/30
Trial completion date
empty
Scientific title
Effect of licorice (Glycyrrhiza glabra) versus placebo on increasing the efficiency of antipsychotics in women with chronic schizophrenia, a double-blind clinical trials
Public title
effect liqurice in treatment of schizophernia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Active schizophrenia Met DSM-IV criteria for chronic schizophrenia Drug regimen of risperidone (6 mg/day), cetirizine (4 mg/day)
Exclusion criteria:
Bipolar disorder Borderline-schizotypal-Antisocial personality disorder ٍEating disorder Alcohol and drug (other than schizophrenia drugs) abuse in the past month Suicide or suicidal ideation History of neurologic and systemic disorders Thyroid dysfunction Administration of antidepressants and Anti-anxiety drugs Steroids (such as oral contraceptives) Use of MAO-I drugs Pregnancy and lactation
Age
From 18 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the permuted block randomization will be used with quadruple blocks. blocks will be produced by using the online site (www.sealedenvelope.com).
Blinding (investigator's opinion)
Double blinded
Blinding description
Unique codes, which is generated by the software, will be used on the drug boxes. By entering each individual into the study based on the produced sequence, the drug box in which the code is registered, will be assigned to the individual. During the research, the randomization list is held by the statistic consultant, and the participants, the project implementer and all those who participate in the measurement of the indicators will not be aware of the assigned groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Road
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Approval date
2012-01-21, 1390/11/01
Ethics committee reference number
ETH-351 , http://behsan.ajums.ac.ir/webdocument/load.action?webdocument_code=1000&masterCode=33003165

Health conditions studied

1

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

Primary outcomes

1

Description
Positive symptoms; Negative symptoms; General psychopathological symptoms
Timepoint
Start intervention and a month later
Method of measurement
PANSS score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: one tablet of D-Reglis (IRAN DAROUK Co., Tehran, Iran) containing 380 mg of standardized dried licorice extract for 8 weeks and three times a day
Category
Treatment - Drugs

2

Description
Intervention group: Placebo (starch + sugar) for 8 weeks and three times a day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Amir Siahpoosh
Street address
Bist-o Chahr Metri St
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2114
Email
Amirsiahpoosh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohamad badavi
Street address
Golestan Road
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3336 2414
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 Siahpoosh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Golestan road
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3334 2197
Fax
Email
siahpoosh-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 Siahpoosh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Golestan Road
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3334 2197
Fax
Email
siahpoosh-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 Siahpoosh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Golestan Road
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3334 2197
Fax
Email
siahpoosh-a@ajums.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
Yes - There is a plan to make this available
Title and more details about the data/document
Only a part of the data will be shared
When the data will become available and for how long
The access period will be 6 months after the publication of the results
To whom data/document is available
The obtained data from current study will be available only for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Six months after the publication of this study papers, the obtained data will be available to the applicant researchers for further analysis
From where data/document is obtainable
Applicants can be contacted with corresponding author by e-mail
What processes are involved for a request to access data/document
Applicants will be able to access the obtained data from current study by sending an email to the corresponding author up to one month
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