The effect of berberine alkaloid on positive and negative symptoms in patients with schizophrenia: a randomized placebo-controlled double-blind clinical trial
Evaluation of the effectiveness of Berberine on improving the symptoms of patients with Schizophrenia
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 60 patients. NCSS (Number Cruncher statistical system) software and block random method are used to randomize the study
Settings and conduct
60 patients with schizophrenia who referred to Ibn Sina Psychiatric Hospital in Shiraz in 2020-21will be included in the study. These people will then be randomly divided into groups receiving placebo and berberine.
Participants/Inclusion and exclusion criteria
Inclusion criteria: schizophrenia; taking antipsychotic medication in the last three months.
Exclusion criteria: having concomitant psychiatric illness; pregnancy or lactation; simultaneous receiving of ECT.
Intervention groups
Intrvention group: patients receive 2 to 6 mg of risperidone daily with a berberine capsule. Placebo group: patients receive 2 to 6 mg of risperidone daily with one placebo capsule.
Main outcome variables
Change in PANSS questionnaire score (positive and negative symptom scale)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190726044339N1
Registration date:2020-12-12, 1399/09/22
Registration timing:registered_while_recruiting
Last update:2020-12-12, 1399/09/22
Update count:0
Registration date
2020-12-12, 1399/09/22
Registrant information
Name
Seyed Hamdollah Mosavat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 4105
Email address
hamdi_88114@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-05, 1399/09/15
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of berberine alkaloid on positive and negative symptoms in patients with schizophrenia: a randomized placebo-controlled double-blind clinical trial
Public title
The effect of berberine on the symptoms of patients with schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having schizophrenia
Received antipsychotic medication in the last three months
Exclusion criteria:
Having other psychiatric disorder
Pregnancy and lactation
Receive concomitant ECT
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher will enrolled participants based on convenience sampling method. NCSS software (Number Cruncher Statistical System) and block randomization method will use for randomization the study. In the block randomization method, participants will categorize into 6 blocks (AABB, ABAB, BBAA, BABA, ABBA, BAAB), each block containing 4 participants. In this study, "A" will assign to the drug group and "B" to the placebo group, for example: in the "ABAB" block, the first person entered the drug group, the second person entered the placebo group, the third person entered the drug group, and the fourth person entered the placebo group. Thus, all eligible participants will randomly assigned to one of the study arms according to the randomization list.
Blinding (investigator's opinion)
Double blinded
Blinding description
Physicians, patients, and drug deliverer will blind to the allocation of intervention. It should be noted that the drugs' containers is the same. Additionally, placebo capsule is similar to beriberine capsule regarding the color and shape
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Ibn Sina Hospital; Hafez street
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2018-05-01, 1397/02/11
Ethics committee reference number
IR.SUMS.MED.REC.1399.371
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Change in PANSS questionnaire score (positive and negative symptom scale)
Timepoint
One month
Method of measurement
PANSS( positive and negative symptom scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Risperson 2 to 6 mg daily with one berberine capsule daily for a month
Category
Treatment - Drugs
2
Description
Control group: Risperson 2 to 6 mg daily with one placebo capsule daily for a month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Psychiatric Hospital(Shiraz)
Full name of responsible person
Dr. Ebrahim Moghimi Sarani
Street address
Hafez street
City
Shiraz
Province
Fars
Postal code
71466 76549
Phone
+98 71 3228 9604
Email
moghimiebrahim@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Moghimi Sarani
Street address
Hafez street
City
Shiraz
Province
Fars
Postal code
71466 76549
Phone
+98 71 3228 9604
Email
moghimiebrahim@yahoo.com
Grant name
Vice Chancellor for Research, Shiraz University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Ghorban Nejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sina Hospital, Hafez St.
City
Shiraz
Province
Fars
Postal code
7654971466
Phone
+98 71 3228 9601
Email
hamdi_88114@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Hamdollah Mosavat
Position
Resident
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sina Hospital, Hafez St.
City
Shiraz
Province
Fars
Postal code
7654971466
Phone
+98 917 840 1495
Email
hamdi_88114@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Hamdollah Mosavat
Position
Resident
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sina Hospital, Hafez St.
City
Shiraz
Province
Fars
Postal code
7654971466
Phone
+98 917 840 1495
Email
hamdi_88114@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available