Effectiveness of acupuncture for gastrointestinal dysfunction in Parkinson's disease

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2024
INTERVENTION: The random allocation sequence will be generated using a random number table method by a statistician not involved in the trial. Allocation sequences will be concealed in sequentially numbered, sealed, opaque (unrecoverable) envelopes to ensure sequence confidentiality. Participants will be randomly allocated (1:1) to either the treatment or the control group. One group will receive 12 sessions of acupuncture treatment over 4 weeks. The other group will receive 12 sessions of sham acupuncture treatment over 4 weeks using non‐penetrating flat needles. Treatment duration is 1 month with assessments at baseline (before the intervention), 4, 12, and 24 weeks. CONDITION: Gastrointestinal dysfunction in patients with Parkinson's disease ; Digestive System PRIMARY OUTCOME: 1. Gastrointestinal dysfunction is measured using the electrogastrogram at baseline and 4 weeks; 2. Blood Serum Index is measured using radioimmunoassay at baseline and 4 weeks; 3. Gastrointestinal dysfunction is measured using the Rome IV functional gastrointestinal disorders (FGID) criteria at baseline and 4 weeks SECONDARY OUTCOME: 1. Stool analysis by 16S‐rRNA high throughput sequencing at baseline and 4 weeks; 2. The extent of Parkinson's disease is measured using the Unified Parkinson's disease rating scale (UPDRS) and the Hoehn–Yahr Rating Scale at baseline, 4, 12 and 24 weeks INCLUSION CRITERIA: 1. Idiopathic PD diagnosis 2. Gastrointestinal dysfunction meeting Rome IV FGIDs criteria 3. Ability to provide written informed consent 4. Men or women aged 40 to 80 years 5. Liver function, kidney function, blood routine, urine routine, and stool routine are all normal
Epistemonikos ID: 804f74ec7f1fff5ac1efde1c9c9e04157ecc8957
First added on: Aug 28, 2024