Determining the therapeutic effect of Terminalia Chebula extract in the treatment of Parkinson's disease catatonia in patients referred to Booali Hospital in Tehran
Design
Clinical trials with control group, Parkinson's disease, with parallel groups, blind, randomized
Settings and conduct
In this double-blind clinical trial study, a total of 50 patients with Parkinson's disease who referred to the neurology clinic of Bu Ali Hospital were included in each treatment group and control group (placebo). These individuals were included in the study in such a way that at the beginning of the study, the intervention group, in addition to receiving L-dopa treatment, were given capsules containing herbal medicine to take one every 12 hours and the control group, in addition to receiving L-dopa treatment, placebo. Have received.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 30 years of age with Parkinson's Age under 70 years Patients who have been definitively diagnosed by a Parkinson's neurologist Patients who have had symptoms for less than 3 months. Exclusion criteria: 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
Intervention groups
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.
Main outcome variables
Catatonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201029049187N1
Registration date:2020-12-30, 1399/10/10
Registration timing:retrospective
Last update:2020-12-30, 1399/10/10
Update count:0
Registration date
2020-12-30, 1399/10/10
Registrant information
Name
Hesam Adin Atashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7798 4996
Email address
h.atashi@student.iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2012-10-21, 1391/07/30
Expected recruitment end date
2013-01-27, 1391/11/08
Actual recruitment start date
2012-09-24, 1391/07/03
Actual recruitment end date
2013-02-13, 1391/11/25
Trial completion date
2013-02-13, 1391/11/25
Scientific title
The effect of a capsule prepared from the aqueous extract of Terminalia Chebula on catatonia in patients with Parkinson's disease
Public title
Therapeutic effect of Terminalia Chebula extract on Parkinson's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Islamic Azad University of Medical Sciences, Tehran, Iran
Street address
Tehran Medical Branch, Islamic Azad University, Khaghani st, Shari'ati Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19395/1495
Approval date
2012-09-21, 1391/06/31
Ethics committee reference number
14085
Health conditions studied
1
Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Parkinson's catatonia
Timepoint
Before the intervention and week 2, 4, 6 after intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Tehran Azad University of Medical Sciences, Khaghani St., Shariati St
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
iautmu@iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Office of Research, Tehran Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Dr. Mehdi Vahid Dastjerdi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Bu'ali Hospital, Damavand Ave, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
17117
Phone
+98 21 3334 8036
Email
Mvdastjerdi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hesam Adin Atashi
Position
MD
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Bu'ali Hospital, Damavand Ave, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
17117
Phone
+98 21 3334 8036
Email
h.atashi@student.iautmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hesam Adin Atashi
Position
MD
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
No. 6, Shahid Beani St., Avicenna Square, Tehran
City
Tehran
Province
Tehran
Postal code
1151811518
Phone
+98 937 650 6313
Email
h.atashi@student.iautmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
After publishing the manuscript in a for 1 year later
To whom data/document is available
All researchers, have no limits
Under which criteria data/document could be used
Provided that the researcher wants to do the same or be interested in further study of this study.
From where data/document is obtainable
Correspond to the research
What processes are involved for a request to access data/document
Email to Person responsible, Checked by the responsible, Providing information