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Comparison of Clinical Response, Pharmacokinetics and Systems Pharmacology Between Dispersible Form of Levodopa and Mucuna pruriens Powder in Parkinson s disease

Phase 1
Recruiting
Conditions
Parkinson&#039
disease patients with motor complication
s disease
Mucuna pruriens
Registration Number
TCTR20220607005
Lead Sponsor
ational Research Council of Thailand (NRCT)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
12
Inclusion Criteria

(1)PD patients above 18 years of age
(2)Patients who diagnose PD according to UKPDSBB criteria.
(3)Patients whose symptoms were stable and medication dosage remained same within 3 months.
(4)Patients who had motor complication at least 2 hours per day in awakening time.
(5)Patients who had ability to record PD diary.

Exclusion Criteria

(1)Patients who had H&Y stage 5 in off period.
(2)Patients who had uncontrolled psychotic symptoms .
(3)Patients who had dementia determine by TMSE score < 23.
(4)Patients who pregnant
(5)Patients who currently use drugs that interfere gastric emptying times
(6)Patients who had unstable disease such as heart disease or renal failure
(7)Patients who had diabetes
(8)Patients who allergy to leguminous plant

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pharmacokinetic 6 hours period AUC, Tmax, Cmax
Secondary Outcome Measures
NameTimeMethod
PDRS score 6 hours period UPDRS part 3
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