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Study of the effectiveness of polyphenol rich extract of licorice as an adjunct therapy on improving symptoms of patients with Parkinson disease

Protocol summary

Study aim
Study of the effectiveness of polyphenol rich extract of licorice as an adjunct therapy on improving symptoms of patients with Parkinson disease
Design
In this phase III, randomized, controlled and double blind trial, 40 patients with Parkinson disease who are attending Emam Reza Clinic will be divided in two parallel groups (drug and placebo) based on block randomization. Diagnose of PD is done according to 2015 MDS criteria.
Settings and conduct
In this randomized controlled trial which is double blinded (participants, physician, neurology assistance in charge of data gathering and the statistician ), 40 Parkinson diseases (PD) patients attending Emam Reza hospital will be randomly divided in two groups. Diagnosis of PD is done according to 2015 MDS criteria. Inclusion criteria are: Age between 30 to 80 years; idiopathic PD; initiation of PD symptoms in recent 6 years; The modified Hoehn and Yahr Scale: staging ≤ 3; no treatment changes within 4 weeks before starting the intervention. The exclusion criteria are: Warfarin, selective serotonin reuptake inhibitors (SSRI), Monoamine oxidase inhibitors (MAOIs), or diuretic consumption; History of diabetes, stroke; myocardial infarction; heart failure; renal failure; cardiac arrhythmia; liver diseases; uncontrolled hypertension and hypokalemia; pregnant and lactating women; complication of treatment including urticaria, pruritis, nasea and vomiting and vertigo Medications will be prepared with similar organoleptic properties under supervision of departments of Pharmacognosy and Pharmaceutics of Shiraz School of pharmacy. The syrups will be coded to be administered double blinded. Treatment group will receive polyphenol rich extract of licorice at the dose of 136 mg/ 5cc syrup, twice a day for 6 months. Placebo syrup will be administered at the same dose (5cc, twice a day for 6 months) to the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Age between 30 to 80 years; idiopathic PD; initiation of PD symptoms in recent 6 years; The modified Hoehn and Yahr Scale: staging ≤ 3; no treatment changes within 4 weeks before starting the intervention. The exclusion criteria are: Warfarin; SSRI, MOA-I, or diuretic consumption; History of diabetes, stroke; myocardial infarction; heart failure; renal failure; cardiac arrhythmia; liver diseases; uncontrolled hypertension and hypokalemia; pregnant and lactating women; complication of treatment including urticaria, pruritis, nasea and vomiting and vertigo
Intervention groups
Intervention 1 Treatment group will receive polyphenol rich extract of licorice at the dose of 136 mg/ 5cc syrup, twice a day for 6 months, in adjunct to the routine treatment of Parkinson disease. Intervention 2 The control group will receive placebo syrup at the same dose (5cc, twice a day for 6 months) in adjunct to the routine treatment of Parkinson disease.
Main outcome variables
Unified Parkinson’s Disease Rating Scale (UPDRS)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120305009204N3
Registration date: 2018-03-12, 1396/12/21
Registration timing: registered_while_recruiting

Last update: 2018-03-12, 1396/12/21
Update count: 0
Registration date
2018-03-12, 1396/12/21
Registrant information
Name
Azadeh Hamedi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4127
Email address
hamediaz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effectiveness of polyphenol rich extract of licorice as an adjunct therapy on improving symptoms of patients with Parkinson disease
Public title
Effect of polyphenol rich extract of licorice on improving symptoms of Parkinson disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30 to 80 years idiopathic parkinson disease (PD) initiation of PD symptoms in recent 6 years The modified Hoehn and Yahr Scale: staging ≤ 3 no treatment changes within 4 weeks before starting the intervention
Exclusion criteria:
Consumption of warfarin; selective serotonin reuptake inhibitors (SSRI), Monoamine oxidase inhibitors (MAOIs), or diuretic History of stroke; myocardial infarction; heart failure; renal failure or cardiac arrhythmia Uncontrolled hypertension and hypokalemia pregnant and lactating women Liver diseases Diabetes complication of treatment including urticaria, pruritis, nasea and vomiting and vertigo
Age
From 30 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
In this trial, participating patients, physicians, the neurological assistant in charge of interviewing patients and collecting data, care provider, as well as the statistician who analyze the data, will be blinded
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical sciences, Zand Street, Shiraz Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2016-02-07, 1394/11/18
Ethics committee reference number
IR.SUMS.MED.REC.1394.80

Health conditions studied

1

Description of health condition studied
Parkinson disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease

Primary outcomes

1

Description
Unified Parkinson’s Disease Rating Scale (UPDRS)
Timepoint
First visit and every 6-8 weeks up to 6 months after intervention began
Method of measurement
Examination by the neurologist physician and Rating the diseases scale based on the Unified Parkinson's Disease Rating Scale (UPDRS)

Secondary outcomes

1

Description
Patients electrolytes level
Timepoint
At the beginning of the study and every 6-8 weeks for six months after the intervention began
Method of measurement
Serologic tests

2

Description
Patients blood pressure
Timepoint
At the beginning of the study and every 6-8 weeks for six months after the intervention began
Method of measurement
Measurement by the physician with a blood pressure monitor

Intervention groups

1

Description
Intervention group: Treatment group will receive polyphenol rich extract of licorice at the dose of 136 mg/ 5cc syrup, twice a day for 6 months, in adjunct to the routine treatment of Parkinson disease.
Category
Treatment - Drugs

2

Description
Control group: The control group will receive placebo syrup at the same dose (5cc, twice a day for 6 months) in adjunct to the routine treatment of Parkinson disease
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza Clinic Dependent to Shiraz University of Medical Science
Full name of responsible person
Dr. Peyman Petramfar; Dr. Azadeh Hamedi; Dr. Fatemeh Hajari
Street address
Emam Reza clinic, Namazi Square, Zand Street
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3212 7000
Email
hamediaz@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ali Poustfroushzadeh
Street address
PO. Box 71345-1978, Central Building of Shiraz University of Medical Sciences, Zand Avenue. Shiraz, Iran Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7882
Email
ali_po58@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Azadeh Hamedi; Dr.Peyman Petramfar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacognosy
Street address
Karafarin street, , School of Pharmacy, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 132424127
Email
hamediaz@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Peyman Petramfar; Dr. Azadeh Hamedi; Dr. Fatemeh Hajari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Karafarin street, , School of Pharmacy, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 132424127
Email
hamediaz@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Azadeh Hamedi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacognosy
Street address
Karafarin Ave., School of Pharmacy, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
1583; 71345
Phone
+98 71 1242 4127
Fax
+98 71 1242 4126
Email
hamediaz@sums.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
Potentially, all data, after unidentifing individuals, can be shared
When the data will become available and for how long
One year after publishing results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Only path analysis for research purposes (Data will not be shared for business purposes or industries)
From where data/document is obtainable
Send an email to Dr. Azadeh Hamedi hamediaz@sums.ac.ir
What processes are involved for a request to access data/document
Send an email to Dr. Azadeh Hamedi, If applicable the documents will be sent
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