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IRCT20210425051074N1 IRCT 2021-06-15 Ahvaz University of Medical Sciences The effect of barberry root on schizophrenia Evaluating the effect of Berberry root (Berberis vulgaris) as Adjuvant Treatment on the prevention of atypical Antipsychotic-Induced metabolic syndrome in Patients With Schizophrenia: A triple-blind, Randomized, Placebo-controlled Trial 2021-06-05 anticipated 106 Complete https://irct.ir/trial/55809 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of assigning the intervention to individuals is random and the method of random permutation blocks with block size 6 (using the table related to random permutations).In the random method, people without a specific pattern or order are included in the study based on the inclusion criteria. Blocking is done to balance the number of samples and the size of both blocks is equal. In this study, patients are treated with medication packages pre-determined by the study supervisor (supervisor). The drug packages are quite similar in shape and the patient and the executor of the project are not aware of the contents of the packages, Blinding description: Patients are treated with medication packages pre-determined by the study supervisor (supervisor). The drug packages are quite similar in shape and the patient and the executor are not aware of the contents of the packages. In addition, data collection, patient assessment and completion of forms is done by the project manager and his assistant who are not aware of the contents of the package. In the data analysis stage, the analysis will be performed by the project consultant and the project manager who are not aware of the contents of the drug packages and only the patient group (group 1 or 2) will be identified for data analysis. Therefore, the study is 3-blind and the contents of the two drug groups are not clear from the stage of patient admission to the study, data collection and analysis. 3 Schizophrenia. Intervention 1: Intervention group: After obtaining written consent and explaining the study conditions, patients are asked to complete a demographic questionnaire that includes age, sex, duration of illness, as well as the use of any medication. The case group is given barberry root capsule, which is made in Ahvaz Medicinal Plants Research Center, three times a day for three months. This extract has been loaded as a study drug in 500 mg capsules. Intervention 2: Control group: After obtaining written consent and explaining the study conditions, patients are asked to complete a demographic questionnaire that includes age, sex, duration of illness, as well as the use of any drug. It is prepared from starch powder with the allowed color in a similar way to medicinal powder. It is loaded in similar capsules and is made in Ahvaz Medicinal Plants Research Center. It is given for a period of three months. Yes - There is a plan to make this available What will be shared: The data can not be shared after identifying individuals, and only part of the main outcome can be shared. When: 6 months after printing the results To whom: Researchers working in academic institutions Conditions: The data are allowed for clinical trials by industry professionals and academic researchers Where to obtain: Provide clear contact information, including mailing addresses for correspondence, or e-mail addresses, or websites, and telephone and fax numbers, along with the names and addresses of those responsible. How to obtain: The applicant must provide the title and abstract of his / her plan along with the exact address Comments:
public Hamzeh Rostami
Ahvaz Golestan Hospital
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3038 rostami-h@ajums.ac.ir Ahvaz University of Medical Sciences scientific Hamzeh Rostami
Ahvaz Golestan Hospital
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3038 rostami-h@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Early diagnosis of schizophrenia They must have recently sought treatment or not received any medication in the past three months Study subjects should be screened for metabolic syndrome. In fact, all patients should be screened for glucose levels, blood lipids, blood pressure, and waist circumference, and ultimately only those with no or at most two of these symptoms should be included in the study The patient is able to take medicine Receive written consent from the patient or parents to enter the study 18 years 55 years Both Pregnant and lactating women Incidence of any side effects of the drug) stomach pain, diarrhea, constipation, bloating, headache, skin complications Existence of any severe and chronic physical diseases (brain, cardiovascular, neurological and seizure diseases, liver, diabetes, hypertension, hyperlipidemia, joints or history of substance use) Mental retardation People treated with antihypertensives, antihypertensives, anticoagulants, sedatives, and drugs that are metabolized by the liver. F20 Schizophrenia Treatment - Drugs Placebo Intervention group: After obtaining written consent and explaining the study conditions, patients are asked to complete a demographic questionnaire that includes age, sex, duration of illness, as well as the use of any medication. The case group is given barberry root capsule, which is made in Ahvaz Medicinal Plants Research Center, three times a day for three months. This extract has been loaded as a study drug in 500 mg capsules Control group: After obtaining written consent and explaining the study conditions, patients are asked to complete a demographic questionnaire that includes age, sex, duration of illness, as well as the use of any drug. It is prepared from starch powder with the allowed color in a similar way to medicinal powder. It is loaded in similar capsules and is made in Ahvaz Medicinal Plants Research Center. It is given for a period of three months. Cholestrol. Timepoint: At the beginning of the study and three months later. Method of measurement: blood sample. Triglyceride. Timepoint: At the beginning of the study and three months later. Method of measurement: blood sample. Blood pressure. Timepoint: At the beginning of the study and three months later. Method of measurement: Hand pressure gauge. Blood suger. Timepoint: At the beginning of the study and three months later. Method of measurement: blood sample. Cholestrol. Timepoint: At the beginning of the study and 3 months later. Method of measurement: blood sample. Blood pressur. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Hand pressure gauge. Blood suger. Timepoint: At the beginning of the study and 3 months later. Method of measurement: blood sample. Waist size. Timepoint: At the beginning of the study and 3 months later. Method of measurement: meter. Triglyceride. Timepoint: At the beginning of the study and 3 months later. Method of measurement: blood sample. Ahvaz University of Medical Sciences Approved 2021-03-09 Ethics Committee of Ahvaz University of Medical Sciences - Golestan Research and Treatment Center (R Golestan hospital , Farvadin Ave , Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)