Determining the effectiveness of Ginkgo biloba in reducing the severity of Parkinson's motor symptoms (based on UPDRS motor score)
Comparison of the degree of change in the severity of drug induced parkinsonism motor symptoms (based on the score of the UPDRS motor department) in patients after the intervention compared to before, between the two groups receiving Ginkgo biloba and placebo
Determining the effectiveness of Ginkgo biloba in improving patients' cognition (based on MoCA score)
Comparison of cognitive change (based on MoCA score) in patients with drug-induced Parkinsonism after the intervention compared to before, between the two groups receiving Ginkgo biloba and placebo
Design
Clinical trial with control group, double-blind, randomized, phase 2 on 102 patients. Block randomization method (block size of four) is used for randomization.
Settings and conduct
Place of study: Roozbeh hospital, neurology Ward
Double blind study
method: By an out-of-study researcher
Participants/Inclusion and exclusion criteria
inclusion criteria: all Psychiatric patients suspected of drug induced parkinsonism
Non-inclusion criteria: Thrombocytopenia, Coagulopathy, Kidney failure
Liver failure, GI bleeding history,
Consumption of warfarin, high dose NSAIDs or NSAIDS with SSRIs and CCBs
Intervention groups
Intervention group: Ginkgo biloba 40 mg tablet; 2 tablets every 8 hours for 3 months. Control group: placebo tablet; 2 tablets every 8 hours for 3 months.
Main outcome variables
Severity of motor symptoms;
cognition of patients;
Quality of life in patients with drug induced parkinsonism.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200708048060N1
Registration date:2022-06-06, 1401/03/16
Registration timing:prospective
Last update:2022-06-06, 1401/03/16
Update count:0
Registration date
2022-06-06, 1401/03/16
Registrant information
Name
Arash Kalantar mehrjardi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2676 9636
Email address
a_kalantarm@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-20, 1401/03/30
Expected recruitment end date
2022-10-07, 1401/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Gingko Biloba efficacy in treatment of drug-induced parkinsonism:; A randomized, double-blind, placebo-controlled clinical trial
Public title
Gingko Biloba efficacy in treatment of drug-induced parkinsonism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All psychiatric patients with the symptoms of drug induced parkinsonism, who have been given neurological counseling and Parkinson's drug-induced event has been confirmed based on clinical judgments and other findings among them
Age over 18 years
Exclusion criteria:
Thrombocytopenia
Coagulopathy
Kidney failure
Liver failure
GI bleeding history
Consumption of warfarin, high dose NSAIDs or NSAIDS with SSRIs and CCBs.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Patient randomization is based on simple randomization method.
Thus, based on the table of random numbers, even numbers are considered for the Ginkgo receiving group and odd numbers for the placebo receiving group. The statistical software used for randomization is R.
Blinding (investigator's opinion)
Double blinded
Blinding description
One of the out-of-field researchers prepared a random sequence of patients and coding the drug packages of each patient. Drugs and placebo tablets, which are similar in appearance, are taken into similar boxes. All tablets required by each patient are packed in coded boxed during the study period. The patient listing is also provided to the field-based researcher based on these codes. All clinical evaluations will be performed by another researcher in the field who is not involved in the allocation process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
13th floor, block A, Headquarters of the Ministry of Health, Treatment and Medical Education, Simaye-Iran st., between Zarafshan and south Falamak st., Shahrak Qods, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419943471
Approval date
2019-12-19, 1398/09/28
Ethics committee reference number
IR.TUMS.TIPS.REC.1398.119
Health conditions studied
1
Description of health condition studied
drug-induced parkinsonism
ICD-10 code
G21.21
ICD-10 code description
Other drug-induced secondary parkinsonism
Primary outcomes
1
Description
Improving the severity of drug induced parkinsonism symptoms in patients
Timepoint
before intervention and 1 and 3 months after intervention