NCT02616120

Effect of SQJZ Herbal Mixtures on Non-motor Symptoms of Parkinson's Disease

Efficacy and Safety of SQJZ Herbal Mixtures on Non-motor Symptoms in Parkinson's Disease Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Dongzhimen Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the efficacy and safety of SQJZ Herbal Mixtures on non-motor symptoms of PD patients.

Detailed description

This will be a multicentre, double-blind, placebo-controlled, parallel-group trial. Patients will be randomly assigned via an random number table to either the SQJZ herbal mixtures or placebo in a 2:1 ratio. Randomization will be stratify by age and gender. All participants are asked to maintain the regular medication schedule during the 12-week intervention. Assessments are conducted prior to the intervention and at 4-week, 8-week and 12-week directly after the intervention. Also, long-term effects will be assessed at 24 weeks of follow-up (from post-enrolment). The assessments will be performed by a blinded investigator who is not involved in the randomization.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	SQJZ herbal mixtures	The SQJZ herbal mixtures is Chinese herb extracts. It contains Rehmannia glutinosa Libosch，Astragalus membranaceus (Fisch.) Bunge etc.( 29.375g, 2 times per day)
DRUG	Placebo	placebo contains 5%SQJZ herbal mixtures and 95% dextrin,identified to SQJZ herbal formula (29.375g, 2 times per day)

Timeline

• Start date: 2015-12-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2015-11-26
• Last updated: 2023-02-21

Locations

1 site across 1 country: China