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Effects of acupuncture on Parkinson's disease-related constipation and roles of gut microbial ecology: protocol for a randomized controlled clinical study

Clinical study on acupuncture treatment of Parkinson's disease complicated with constipation (PDC)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082060
Enrollment
Unknown
Registered
2024-03-20
Start date
2024-03-21
Completion date
Unknown
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson disease

Interventions

Acupuncture group:Acupuncture and anti-Parkinson's drugs
Waiting group:Anti-Parkinson's drugs
Sham-acupuncture group:Sham-acupuncture and anti-Parkinson's drugs

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Diagnosed with Idiopathic PD and constipation; 2) Hoehn-Yahr scale grades 1 to 3; 3) Good compliance, able to understand the research content, and cooperate with the completion of the defecation diary and scale, and cooperate with the completion of stool collection; 4) Drugs that could affect the gut flora are not taken within 1 month, including antibiotics and probiotics; 5) Aged from 35 to 80; 6) Participate voluntarily and sign informed consent; 7) The course of Parkinson's disease is not less than 6 months, and anti-Parkinson drugs are taken regularly for more than 3 months according to regulations; 8) Did not participate in other drugs or acupuncture clinical trials within 1 month prior to inclusion in the study.

Exclusion criteria

Exclusion criteria: 1) Organic lesions of the digestive system (such as intestinal adhesions, intestinal obstruction, tumors or malformations in the gastrointestinal tract, etc.), or history of abdominal surgery or anorectal surgery that may affect intestinal transport, or systemic diseases that affect digestive motility (such as diabetes, hyperthyroidism, etc.); Serious cardiovascular and cerebrovascular diseases, hematopoietic diseases, malignant tumors or other serious life-threatening diseases; Have a clear history of mental illness or accompanied by psychotic symptoms; 2) Skin lesions at the acupuncture site, or patients who are not suitable for acupuncture due to acupuncture, pneumothorax, spontaneous bleeding, etc., and those who are allergic or intolerant to acupuncture treatment; 3) Fear of acupuncture, pregnant and lactating women; 4) A history of substance abuse (such as alcohol, drugs, caffeine) in the past six months; 5) Use probiotics or antibiotics in the first 4 weeks; 6) Patients who developed diarrhea within the last 2 weeks were suspended from inclusion; 7) Women who have plans to have children in the near future.

Design outcomes

Primary

MeasureTime frame
Unified Parkinson's Disease Rating Scale;

Secondary

MeasureTime frame
The Non-Motor Symptoms Scale;Stool diary;30m walking test;Gut microbiota;Lipopolysaccharide;Lipopolysaccharide-binding protein;

Countries

China

Contacts

Public ContactZhuang Lixing

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

zhuanglixing@163.com+86 138 2228 7775

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026