Traditional Chinese medicine syndrome differentiation and treatment by stages of Parkinson’s disease: study protocol for a multicentre, randomized, double-blind, placebo-controlled clinical trial

Table 2 Schedule of assessments

Assessments	Group			Study period							O
Assessments	Group			Enrolment	Allocation	Intervention				Follow-up
Timepoint	Mi	Mo	A	−T1	T0	T1	T2	T3	T4	T5
Enrolment				×
Eligibility screen	×	×	×	×
Informed consent	×	×	×	×
Allocation	×	×	×		×
Randomization	×	×	×		×
Intervention
Ziyin Pingchan formula	×					×	×	×	×
Jiedu Pingchan formula		×				×	×
Fuzheng Pingchan formula			×			×	×
Time of first addition of levodopa	×			×		×	×	×	×	×	P^Mi
UPDRS	×	×	×	×		×	×	×	×	×
PDSS-2	×	×		×		×	×	Mi	Mi	×
ESS	×	×		×		×	×	Mi	Mi	×
RBDSQ	×	×		×		×	×	Mi	Mi	×
HAMD	×	×		×		×	×	Mi	Mi	×
HAMA	×	×		×		×	×	Mi	Mi	×
SCOPA-AUT	×	×		×		×	×	Mi	Mi	×
NMSS	×	×	×	×		×	×	Mi	Mi	×
PDQ-39	×	×	×	×		×	×	Mi	Mi	×	P^A
Elderly quiver of TCM syndrome classification dysfunction score	×	×	×	×		×	×	Mi	Mi	×
Duration of “OFF” period		×		×		×	×			×	P^Mo
Hoehn-Yahr stage		×		×		×	×			×
WCSS		×		×		×	×			×
WOQ-9		×		×		×	×			×
UDysRS		×		×		×	×			×
AIMS		×		×		×	×			×
PDYS-26		×		×		×	×			×
FOGQ		×		×		×	×			×
CBI			×	×		×	×			×
MMSE			×	×		×	×			×
MoCA			×	×		×	×			×
LED		×		×		×	×			×
Infection			×	×		×	×			×
Hospitalization			×	×		×	×			×
Survival			×	×		×	×			×
UA	×	×		×		×	×	Mi	Mi	×
Hcy	×	×		×		×	×	Mi	Mi	×

Mi mild, Mo moderate, A advanced, T0 baseline, T1 week 12, T2 week 24, T3 week 36, T4 week 48, T week60, O outcome

ISSN: 1749-8546