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IRCT20211012052739N1 IRCT 2021-11-08 Fasa University of Medical Sciences "The effect of herbal supplements on neurotransmitters in the formation of dementia" "Evaluation of the possible effect of berberine supplementation on changes in serum levels of glutamate-dopamin-serotonin and GABA neurotransmitters in dementia patients" 2021-10-25 anticipated 105 Complete https://irct.ir/trial/59282 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: The sample selection method is randomization based on random blocks in which A, B and C are considered as drugs, placebo and control. It consists of 35 blocks and is selected and placed one after the other, referring to the random Excel numbers of the ABC block, Blinding description: The drugs are encapsulated by the partner pharmacist in the design according to the principles of pharmacy and are placed in the same packages named A and B. Packages containing the drug are delivered to the patients after the conditions are met for entry into the study and based on the randomized forms. The control group includes healthy people who are according to age and gender according to the group.It is a drug and placebo and is considered to study the normal serum level of neurotransmitters. 2-3 Dementia. Intervention 1: Intervention group: Berberine is a herbal supplement, in the form of a capsule, with a dose of 300 mg, given three times a day for two months for patients with dementia. Medication should be taken after a meal. The number in each package is 30 capsules and the country of manufacture of Iran is Omid Parsina Damavand Company. Intervention 2: Control group: Healthy people without receiving treatment protocols. Intervention 3: Control group:The composition of 300 mg of starch, in the form of capsules, is consumed three times a day. Yes - There is a plan to make this available What will be shared: Individual data of study participants in accordance with the principle of confidentiality, informed consent form, protocol and how to conduct the study, part of the information obtained based on changes in the initial consequences When: 12 months after receiving permission from IRCT Center To whom: Only researchers working in educational, research and treatment centers affiliated to the Ministry of Health of the Islamic Republic of Iran Conditions: Only in order to implement the research stages of research projects and also necessarily mention the research center of this study (Fasa University of Medical Sciences) Where to obtain: Hamidreza Rahmani, Email Address: h.rahmani@fums.ac.ir, Contact Number: 09036016381, Address: Biochemistry Department, Fasa University of Medical Sciences, Ibn Sina Square How to obtain: 1. Sending a request to the IRCT Center and then contacting the respondent scientifically or publicly of the study. 2. Sending a formal and written request to the respondent in the study. 3. Referral of the request to the Vice Chancellor for Research of that university. Ethics is provided to the applicant. 5. The total process time is 20 days. Comments:
public Hamidreza Rahmani
Fasa University of Medical Sciences., Ibn Sina Square
ّFasa Iran (Islamic Republic of) 7461791695 +98 71 5335 0994 h.rahmani@fums.ac.ir Fasa University of Medical Sciences scientific Bahram Movahedi
Fasa University of Medical Sciences., Ibn Sina Square
Fasa Iran (Islamic Republic of) 7461791695 +98 71 5335 0994 asad17400@yahoo.com Fasa University of Medical Sciences Iran (Islamic Republic of) Inclusion age (at least 65 years) Complete DSM_IV diagnostic questionnaires by a partner specialist Proof of dementia by CT scan, MRI The same conditions as the severity of the disease 65 years no limit Both Having similar neurological disorders Alcohol consumption history in the past year History of gastrointestinal diseases F03. 90 Dementia in other diseases classified elsewhere without behavioral disturbance Treatment - Drugs Diagnosis Placebo Intervention group: Berberine is a herbal supplement, in the form of a capsule, with a dose of 300 mg, given three times a day for two months for patients with dementia. Medication should be taken after a meal. The number in each package is 30 capsules and the country of manufacture of Iran is Omid Parsina Damavand Company. Control group: Healthy people without receiving treatment protocols Control group:The composition of 300 mg of starch, in the form of capsules, is consumed three times a day. GABA amino butyric acid. Timepoint: At the beginning of the study (before the intervention) and 60 days after starting the drug. Method of measurement: High-performance liquid chromatography. Dopamine. Timepoint: At the beginning of the study (before the intervention) and 60 days after starting the drug. Method of measurement: High-performance liquid chromatography. Serotonin. Timepoint: At the beginning of the study (before the intervention) and 60 days after starting the drug. Method of measurement: High-performance liquid chromatography. Glutamate. Timepoint: At the beginning of the study (before the intervention) and 60 days after starting the drug. Method of measurement: High-performance liquid chromatography. Improving patient memory and slowing the progression of patient perceptual defects. Timepoint: 60 days after starting Berberine supplementation. Method of measurement: Questionnaire for scores of clinical change assessment (CGI) and psychiatric grading criteria (BpRS). Fasa University of Medical Sciences Approved 2021-10-09 Ethics Committee of Fasa University of Medical Sciences Fasa University of Medical Sciences., Ibn Sina Square Fasa Fars Iran (Islamic Republic of)