The effect of herbal medicine Schizoherb on the weight of patients with schizophrenia receiving atypical antipsychotic
Design
This is a triple blind randomised controlled trial. Patients are divided into control and intervention groups using random blocking method by www.sealedenvelop.com. Opaque sealed envelopes are used for allocation concealment.
The sample size is 32 patients in each group.
Settings and conduct
Schizophrenic patients referred to the clinic of Ibn Sina Hospital in Mashhad, who are eligible for admission, are randomly divided into two groups of intervention and control for 8 weeks. Biochemical lab tests and measurement of body weight and blood pressure and completion of the 36-item WHOQol questionnaire and PANSS questionnaire are performed at the beginning and end of the study for patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with schizophrenia aged 18 to 65 years, receiving second-generation antipsychotics who do not have serious systemic disease (including liver or kidney failure, known heart disease, hypothyroidism, hypertension) and have not changed the type and dose of antipsychotic medication for at least the past 3 months. .
Criteria for non-entry: 1- Dependence on substances (except cigarettes)
2- Women during pregnancy or lactation
3- Liver tests more than twice normal
4- Sensitivity to any of the design plants
Intervention groups
Intervention group: with continuation of antipsychotic drug, administration of 700 mg schizoherb herbal capsule, twice a day for 8 weeks
Control group: with continuation of antipsychotic drug, administration of placebo capsules, twice a day for 8 weeks
Main outcome variables
weight
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210707051813N1
Registration date:2021-08-21, 1400/05/30
Registration timing:prospective
Last update:2021-08-21, 1400/05/30
Update count:0
Registration date
2021-08-21, 1400/05/30
Registrant information
Name
Hamideh Naghibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2701
Email address
naghibih1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Schizoherb on atypical antipsychotics-induced weight gain in patients with schizophrenia
Public title
"Effect of Schizoherb on atypical antipsychotics-induced weight gain"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 to 65 years
No serious systemic disease (including liver or kidney failure, known heart disease, hypothyroidism, hypertension) based on history and physical examination and lab tests and approved by a psychiatrist
No changes in the type and dose of antipsychotic drug in at least the last 3 months
Exclusion criteria:
Dependence on substances (except cigarettes)
Women during pregnancy or lactation
Liver functional tests more than twice normal
History of allergies to any of the plants in the design
Consumers of aripiprazole
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Using sealedenvelope.com and random blocking method, patients are placed in the intervention or control group. 16 blocks of 4 will be produced and the sequence produced by the design statistician will be placed in opaque sealed envelopes and numbered, respectively.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is three-blinded (blinding the subjects, evaluators and analysts). Instead of the intervention and control group, A and B are used to blind the analyst. The outcome assessor is someone outside the research group. The intervention group is given Schizoherb herbal capsules in addition to previous medications and the control group is given placebo capsules in addition to previous medications.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Daneshgah Street
City
mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2021-06-19, 1400/03/29
Ethics committee reference number
IR.MUMS.REC.1400.075
Health conditions studied
1
Description of health condition studied
Weight gain side effect in patients with schizophrenia receiving atypical antipsychotics
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
weight
Timepoint
Before the beginning of study (week zero) and the end of study (week eight)
Method of measurement
Measuring body weight (in kilograms) and height (in meters) and calculating body mass index or BMI (in kg / m2), measuring waist circumference with a tape measure (in centimeters) and calculating WHR (waist- hip circumference ratio)
Secondary outcomes
1
Description
fasting blood suger
Timepoint
beginning and end of the study
Method of measurement
by blood sample (in mg/dl)
2
Description
lipid profile
Timepoint
beginning and end of the study
Method of measurement
by blood sample (in mg/dl)
3
Description
measuring blood pressure
Timepoint
beginning and end of the study
Method of measurement
Using a mercury barometer (in mmhg)
4
Description
Check the quality of life
Timepoint
beginning and end of the study
Method of measurement
Using the World Health Organization quality of life questionnaire (WHOQol - Bref)
5
Description
Evaluation of the severity of positive and negative symptoms of schizophrenia. (According to the available articles, the herbs used in the design are expected to be effective in reducing negative symptoms. In most interventional studies in schizophrenic patients, the severity of symptoms is assessed during the study.)
Timepoint
weeks 0, 4 , 8
Method of measurement
PANSS questionnaire
Intervention groups
1
Description
Simultaneously with the continuous use of antipsychotic drugs, in the intervention group, Schizoherb capsules (including three herbs green tea, Persian borage and portulaca oleracea, formulated in the laboratory of Mashhad School of Traditional and Complementary Medicine, Iran), in the form of 700 mg capsules are prescribed twice a day for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: In the control group, placebo capsules containing Avisel, made in the laboratory of Mashhad School of Traditional and Complementary Medicine, are added to the patient's treatment regimen for 8 weeks.