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A single center randomized controlled clinical study of integrated traditional Chinese and Western medicine in the treatment of Parkinson's disease with functional constipatio

Not Applicable
Conditions
Parkinson's disease
Registration Number
ITMCTR2200006631
Lead Sponsor
The Second Affiliated Hospital of Nanchang University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

? The patients with Parkinson's disease were in accordance with the 2015 International Sports Disability Association.
? meet the Rome ? functional constipation diagnostic criteria;
? Age between 30 and 75 years old;
?PD duration =6 months, constipation duration =3 months;
? For patients who have received anti-PD western drugs, their medication regimen (including western drug dose) should be carried out stably for 4 weeks before they can enter the trial phase; Early stage patients who are not receiving anti-PD therapy can proceed directly to the trial phase;
? If you have received constipation treatment but for the current treatment is not satisfied with the request to stop taking both the use of laxatives after 2 weeks to enter the trial phase, constipation before the test can be treated with physical methods or open plug; If you have not received treatment for constipation, you can directly enter the trial phase;
? The modified Hoehn-Yahr (H-Y) classification belongs to the 1-3 grade;
? Simple intelligence scale score (MMSE) : according to the patient's education level of illiteracy > 17 points, primary education > 20 points, middle school culture > 24 points;
? Volunteer to participate in this study, receive relevant examination and treatment, and sign the informed consent form.

Exclusion Criteria

? Patients with serious cardiovascular and cerebrovascular diseases, hematopoietic diseases, malignant tumors and other serious life-threatening diseases;
? Patients with previous or current diagnosis of schizophrenia, major depression and other psychotic disorders or cognitive dysfunction (MMSE: illiteracy primary school secondary school Patients who have previously undergone laparotomy or anorectal surgery (except hemorrhoid surgery alone, one year after appendectomy, and inguinal hernia repair) that may affect intestinal transmission function;
? Patients who were previously or currently diagnosed as anal tumors, malformations or suspected of intestinal obstruction and other organic diseases leading to constipation ?;
? Patients with acute gastrointestinal diseases within 2 weeks before treatment;
? Patients who take antidepressants, analgesics and antihistamines affecting PD symptoms within 2 weeks before treatment;
Pregnancy or lactation of female patients (female patients under 60 years of age for urine pregnancy test).
? Subjects who used antibiotics 1 month before enrollment and had poor compliance;
?Subjects who had taken traditional Chinese medicine or proprietary Chinese medicine, probiotics or fermented milk containing probiotics within 1 month before enrollment.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
High throughput sequencing of gut microbiota;MDS-UPDRS III;
Secondary Outcome Measures
NameTimeMethod
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