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IRCT20201029049187N1 IRCT 2020-12-30 Islamic Azad University Therapeutic effect of Terminalia Chebula extract on Parkinson's disease The effect of a capsule prepared from the aqueous extract of Terminalia Chebula on catatonia in patients with Parkinson's disease 2012-10-21 anticipated 50 Complete https://irct.ir/trial/52147 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 50 patients with Parkinson's disease were selected by simple randomization and divided into case and control groups. In order to collect data, eligible patients who participated in the study were randomly and bi-blindly assigned by the project secretary to two groups receiving capsules containing Terminalia Chebula (in the treatment group) and Placebo capsules were divided into control group. These drugs were placed in two packages (package A, package B) and were given to patients according to the division of people into two groups. None of the patients knew about the type of medicine in the packages and the concealment was done correctly. In this type of sampling, each member of the community is given an equal chance to be selected in the sample. In order to select a simple random sample by lottery method, according to the sampling framework from among the members of the community, a sample with the desired sample size should be selected from the people listed by lot. In the lottery method, we wrote the names of the people on a piece of paper and placed them inside the box, then took out the papers one by one until the desired sample size was completed, Blinding description: In this study, 4 groups of patients, clinical caregiver, outcome assessor and data analyzer were kept blind. None of these men knew which containers contained the Black Halil capsule or the placebo capsule. Blinding was performed carefully in this study so that the patients were divided into two groups by the project secretary receiving capsules containing Terminalia Chebula (in the treatment group) and placebo capsules in the control group. These drugs were placed in two packages (package A, package B) and were given to patients according to the division of people into two groups. None of the patients knew about the type of medicine in the packages and the concealment was done correctly. None of the drugs were disclosed to patients, clinicians, outcome assessors, and data analyzers. 2-3 Parkinson's disease. Intervention 1: Intervention group: Terminalia Chebula extract capsule group: In addition to the main treatment for Parkinson's disease, which is L-dopa judgment, patients were given capsules containing Terminalia Chebula and patients were advised to take 1 every 12 hours. 2, 4 and 6 weeks after the first visit were performed in the next visits and the patients were catatonically evaluated during the night rest and during daily activities, the next visit tests were evaluated and the relevant results were recorded in the questionnaires. According to the method (Morpurgo 10), the catatonic progression and its reduction are examined by observing the patient's movements and assigning points. Intervention 2: Control group: Group receiving placebo: In this group, patients are given placebo and in addition to receiving L-dopa treatment, patients were told to take one placebo capsule every 12 hours. It should be noted that patients are completely blind and do not know that drugs are placebo. Follow-up of patients was performed in 2, 4 and 6 weeks after the first visit in the next visits, respectively, and the patients were catatonically evaluated during the night rest and during daily activities, testing of the next visits and recording the relevant results in the questionnaires. Been. According to the method (Morpurgo 10), the catatonic progression and its reduction are examined by observing the patient's movements and assigning points. Yes - There is a plan to make this available What will be shared: All data can be shared after identifying individuals. The effect of capsules containing Terminalia Chebula extract in the treatment of Parkinson's catatonia is shared. Sharing all the data and documents of this study to people who are conducting similar studies or are interested in paying more attention to this study is unrestricted. When: After publishing the manuscript in a for 1 year later To whom: All researchers, have no limits Conditions: Provided that the researcher wants to do the same or be interested in further study of this study. Where to obtain: Correspond to the research How to obtain: Email to Person responsible, Checked by the responsible, Providing information Comments:
public Dr. Mehdi Vahid Dastjerdi
Bu'ali Hospital, Damavand Ave, Imam Hossein Square, Tehran
Tehran Iran (Islamic Republic of) 17117 +98 21 3334 8036 Mvdastjerdi@yahoo.com Islamic Azad University scientific Hesam Adin Atashi
Bu'ali Hospital, Damavand Ave, Imam Hossein Square, Tehran
Tehran Iran (Islamic Republic of) 17117 +98 21 3334 8036 h.atashi@student.iautmu.ac.ir Islamic Azad University Iran (Islamic Republic of) Patients over 30 years of age with Parkinson'sAge under 70 years Patients who have been definitively diagnosed by a Parkinson's neurologist Patients who have had symptoms for less than 3 months 30 years 70 years Both Age over 70 years Age under 30 years Uncertain diagnosis of Parkinson's Has had Parkinson's symptoms for more than 3 months and has not been diagnosed G20 Parkinson's disease Treatment - Drugs Placebo Intervention group: Terminalia Chebula extract capsule group: In addition to the main treatment for Parkinson's disease, which is L-dopa judgment, patients were given capsules containing Terminalia Chebula and patients were advised to take 1 every 12 hours. 2, 4 and 6 weeks after the first visit were performed in the next visits and the patients were catatonically evaluated during the night rest and during daily activities, the next visit tests were evaluated and the relevant results were recorded in the questionnaires. According to the method (Morpurgo 10), the catatonic progression and its reduction are examined by observing the patient's movements and assigning points. Control group: Group receiving placebo: In this group, patients are given placebo and in addition to receiving L-dopa treatment, patients were told to take one placebo capsule every 12 hours. It should be noted that patients are completely blind and do not know that drugs are placebo. Follow-up of patients was performed in 2, 4 and 6 weeks after the first visit in the next visits, respectively, and the patients were catatonically evaluated during the night rest and during daily activities, testing of the next visits and recording the relevant results in the questionnaires. Been. According to the method (Morpurgo 10), the catatonic progression and its reduction are examined by observing the patient's movements and assigning points. Parkinson's catatonia. Timepoint: Before the intervention and week 2, 4, 6 after intervention. Method of measurement: questionnaire. Quality of life Score and Symptoms. Timepoint: Before the start of the study and 2 months after the start of the study. Method of measurement: Parkinson's Disease Questionnaire =PDQ-39. Office of Research, Tehran Islamic Azad University Approved 2012-09-21 Ethics Committee, Islamic Azad University of Medical Sciences, Tehran, Iran Tehran Medical Branch, Islamic Azad University, Khaghani st, Shari'ati Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)