A randomized double-blind placebo-controlled multicenter trial of Bushen Yisui and Ziyin Jiangzhuo (BYZJ) Formula for constipation in Parkinson's disease
- Conditions
- Parkinson' disease
- Registration Number
- ITMCTR2000003091
- Lead Sponsor
- Beijing Rehabilitation Hospital, Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Diagnosed as idiopathic PD according to the 2015 MDS criteria;
2. Diagnosed as constipation according to Rome III diagnostic criteria;
3. Aged 30 to 80 years;
4. Hoehn and Yahr classification 1-4;
5. Sign informed consent and be able to insist on completing the entire treatment process.
1. Patients who do not take medication under the guidance of a professional doctor or cannot take medication regularly;
2. Patients with intestinal organic lesions such as intestinal polyps, intestinal tuberculosis, Crohn's disease, tumors and ulcers. etc;
3. Secondary constipation caused by uremia, muscular dystrophy, multiple sclerosis, hypothyroidism and other system diseases;
4. Patients with severe heart, brain, liver, kidney, blood system diseases, as well as mental disorders or dementia;
5. Higher serum creatinine, ALT or AST than twice the normal value;
6. According to the judgment of the researcher, patients who are unable to cooperate throughout the research due to drug abuse or poor adherence;
7. Participated in other studies in the past 2 weeks or is currently participating in other clinical trials; or has taken other traditional Chinese medicine preparations in the past 3 months;
8. Pregnant and lactating women.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method constipation severity instrument;
- Secondary Outcome Measures
Name Time Method PAC-QOL;PDSS;PFS-16;BSFS;NMSS;MDS-UPDRS;