Study on spatio-temporal regulation mechanism of acupuncture intervention on central inflammatory network in stable COPD patients based on brain-gut axis

Phase 1

• Conditions: chronic obstructive pulmonary disease

• Registration Number: ITMCTR2200006810
• Lead Sponsor: Hospital of Chengdu University of Traditional Chinese Medicine / Chengdu University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) For patients diagnosed with COPD, the disease has been stable for at least the past 4 weeks without acute exacerbation;
(2) 40 years old = age = 80 years old, gender is not limited; right-handed;
(3) Patients with FEV1 between 25% and 80% after inhalation of bronchodilators;
(4) The patient has at least one moderate or severe acute exacerbation in the past year;
(5) According to the recommended medication regimen of GOLD, received stable western medicine treatment within 3 months before treatment;
(6) No history of infection or aggravation of respiratory symptoms for at least the past 4 weeks, no drug changes within 3 months before the start of the study, and no symptoms of edema;
(7) Montreal Cognitive Assessment Basic Edition (MoCA-B) low education group (=6 years) =20 points, middle school group (7-12 years) =23 points, university group (>12 years) =25 points;
(8) Patients who have not undergone pulmonary rehabilitation in the past 6 months;
(9) Good compliance, willing to cooperate with the research, and the patients signed the informed consent.

Exclusion Criteria

(1) Patients with severe cardiovascular and cerebrovascular, nervous system, blood system, immune system, digestive system diseases, chronic liver and kidney insufficiency, malignant tumors, and uncontrolled blood pressure and blood sugar;
(2) Segmentectomy, wedge resection or lobectomy, pneumonectomy, or lung volume reduction surgery (including bronchoscopy lung volume reduction surgery) due to COPD;
(3) Other concomitant active or clinically significant respiratory diseases that have a significant impact on the research: such as subjects with active pulmonary tuberculosis, bronchiectasis, pulmonary hypertension, pulmonary interstitial disease or other active pulmonary diseases;
(4) Those who use long-term oxygen therapy (oxygen therapy time > 15h/d) or mechanical ventilation;
(5) Those who have a history of mental illness, mental retardation, or inconvenience in movement, who could not be sedated and cooperated with the examination at that time;
(6) Those with coagulation dysfunction or severe skin damage and infection
(7) Pregnant or lactating women;
(8) Those who have metal implants in the body and suffer from claustrophobia and other contraindications to MRI examinations;
(9) Severe cranial anatomical structure asymmetry or clear lesions are found in MRI scans;
(10) Moderate constipation in the past 3 months (duration > In June, or < 6 months, but the symptoms of constipation are serious, conscious of pain, conservative treatment is ineffective or poor, seriously affect life) or moderate diarrhea (watery stool, 3~5 times within 24 hours, conscious of pain or interference with daily activities);
(11) Received drug treatment for cholecystitis, digestive tract ulcer, urinary tract infection, acute pyelonephritis, cystitis in the past 1 month;
(12) Antibiotics have been used in the past 3 months for 3 days or more;
(13) Those who participated in other clinical trials within the past 3 months or at the same time.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
St. George's Respiratory Questionnaire;

Secondary Outcome Measures

Name	Time	Method
PSQI;modified Medical research council;Self-rating depression scale;Pulmonary function test;Borg dyspnea score before and after 6MWT;Self-rating anxiety scale;The number of patients with acute exacerbation of COPD and the proportion of occurrence times;SF-36 Quality of Life Score;Walking distance for the 6-minute walk test;COPD assessment test;