Table 1 Schedule of enrolment, interventions, and assessments
Timepoint | Study period | ||||||
|---|---|---|---|---|---|---|---|
Enrolment | Allocation | Post-allocation | Follow-up | ||||
-t1 | 0 | t1 (Week 1–4) | t2 (after 4 weeks) | t3 (after 16 weeks) | t4 (after 32 weeks) | t5 (after 38 weeks) | |
Enrolment: | |||||||
Eligibility screen | X | ||||||
Informed consent | X | ||||||
Medical history | X | ||||||
Renal and Liver function test | X | X | X | ||||
Chinese medicine pattern differentiation | X | ||||||
Allocation | X | ||||||
Interventions: | |||||||
Chinese herbal medicine (for treatment group) | X | X | X | X | |||
Compliance to intervention (for treatment group) | X | X | X | X | |||
Conventional medication (for all groups) | X | X | X | X | |||
Assessments: | |||||||
MDS-UPDRS Part II | X | X | X | X | |||
MDS-UPDRS Part I, III, IV, total scores | X | X | X | X | |||
NMSS | X | X | X | X | |||
Adverse events | X | X | |||||