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Efficacy and Safety of SQJZ Herbal Mixtures on Non-motor Symptoms in Parkinson's Disease Patients (ESNMS)
The purpose of this study is to examine the efficacy and safety of SQJZ Herbal Mixtures on non-motor symptoms of PD patients.
Details
| Lead sponsor | Dongzhimen Hospital, Beijing |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 240 |
| Start date | 2015-12 |
| Completion | 2023-12 |
Conditions
- Parkinson's Disease
Interventions
- SQJZ herbal mixtures
- Placebo
Primary outcomes
- changes of The Nonmotor Symptoms Scale (NMSS) from baseline after 12-weeks treatment. — baseline, 4-week, 8-week, 12-week and 24-week.
The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; miscellaneous. Severity and frequency are rated using a 4-point scale ranging from 0 (none) to 3 (severe; major source of distress or disturbance to subject) for severity and from 1 (rarely) to 4 (very frequent \[daily or all the time\]) for frequency. The total NMSS score ranges from 0 to 350. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The NMSS was assessed at introduction period, baseline, 4-week, 8-week, 12-week and 24-week.
Countries
China