NCT05930262|Completed
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Sponsor study identifier
interventional
72
1 country
1
Study Start
May 1, 2020
Actual (reported)Primary Completion
May 31, 2021
Actual (reported)Study Completion
June 1, 2023
Actual (reported)The goal of this prospective randomized controlled study is to explore the clinical efficacy of acupuncture therapy combined with breathing training in patients with stroke complicated with pulmonary infection. The intervention group and control group were treated with conventional drug therapy, rehabilitation therapy and breathing training for 2 consecutive weeks. On this basis, the intervention group additionally received acupuncture therapy. To evaluate the clinical efficacy of both groups.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2023
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2020
Actual (reported)May 31, 2021
Actual (reported)June 1, 2023
Actual (reported)June 6, 2023
Actual (reported)July 5, 2023
Actual (reported)Serum inflammatory factors：C-reactive protein (CRP) level
C-reactive protein (CRP) level(mg/L)
2 Weeks
Serum inflammatory factors：Calcitonin (PCT) level
Calcitonin (PCT) level(ng/mL)
2 Weeks
Serum inflammatory factors：WBC
WBC (x 109/L)
2 Weeks
Improvement time for symptoms and signs of pulmonary infection：Time of fever relieving
the time for body temperature to return to normal (d)
2 Weeks
TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training
Conventional drug therapy Rehabilitation therapy Breathing training
TCM acupuncture therapy: Zusanli, Quchi, Hegu, Taichong, Feishu and Fenglong were selected as the main acupoints, and the auxiliary acupoints were selected according to the symptoms, including Fengchi, Dazhui, Lieque, Tiantu, Shenshu, Zhongfu, etc.
Antibiotics were selected based on drug sensitivity test results. Patients with body temperature \> 38.5℃ were treated with physical cooling and antipyretic drugs. In patients whose sputum was thick and difficult to cough up, nebulization and inhalation therapy was given, as well as effective coughing and patting the back to expel phlegm were guided.
Acupuncture Therapy Combined with Breathing Training for Patients with Stroke Complicated with Pulmonary Infection: A Clinical Study
Shijiazhuang, Hebei, 050000, China
72 participants (actual enrollment reported by the registry).
First Submitted
June 6, 2023
First Posted
July 5, 2023
Study Start
May 1, 2020
Actual (reported)Tongyuan Acupuncture on Consciousness Disorder After Stroke
Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of cough
the time for the disappearance of cough (d)
2 Weeks
Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of expectoration
the time for the disappearance of expectoration (d)
2 Weeks
Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of moist rales
the time for the disappearance of moist rales (d)
2 Weeks
TCM syndrome score
Before and after treatment, TCM syndrome scores were counted in the two groups. The main and secondary symptoms were classified into 4 levels, with scores of 0, 1, 2 and 3 based on the severity of the symptoms. The tongue coating and pulse pattern were scored into 2 levels, with no scored as 0 and yes as 1. The sum of various scores was calculated as the total score, with a score range of 0-36. The higher the score, the severer the condition.
2 Weeks
Clinical pulmonary infection score (CPIS)
Before and after treatment, the 2 groups were scored comprehensively based on the average range of 12-h body temperature, WBC range, amount and character of tracheal secretions, index of gas exchange, pulmonary infiltration shadow of X-ray chest film, and pathogenic bacteria in sputum culture. According to the severity, they were divided into 3 levels, with a score of 0, 1 and 2. The maximum score was 12. The higher the score, the severer the infection.
2 Weeks
Pulmonary indexes:forced vital capacity (FVC)
To measure the forced vital capacity (FVC)(L) before and after treatment
2 Weeks
Pulmonary indexes:forced expiratory volume in the first second (FEV1)
To measure the forced expiratory volume in the first second (FEV1)(L/S) before and after treatment
2 Weeks
Pulmonary indexes: peak expiratory flow (PEF)
To measure the peak expiratory flow (PEF)(L/S) before and after treatment
2 Weeks
Efficacy evaluation:Number of patients with clinical efficacy（Cured，Effective，Remarkably effective，Invalid）
Efficacy was evaluated according to the Criteria of Diagnosis and Therapeutic Effect of Diseases and Symptoms in Traditional Chinese Medicine . Cured: Clinical adverse symptoms such as cough, expectoration and chest tightness disappeared, inflammation was absorbed on X-ray or CT, and routine blood indexes were normal. Remarkably effective: Adverse symptoms such as cough, expectoration and chest tightness were improved significantly, and X-ray or CT and routine blood test results basically returned to normal. Effective: Clinical adverse symptoms such as cough, expectoration and chest tightness were relieved, and X-ray or CT and routine blood test results were improved partially. Invalid: Clinical adverse symptoms such as cough, expectoration and chest tightness had no changes or aggravated.
2 Weeks
Comprehensive training for hemiplegic limbs included a joint range of motion training, bridging exercise, turnover training, balance training, gait training, hand function training and self-care ability training, 40 min/d, 6 times/w.
Training was conducted daily in the morning, or after symptom relief in the case of fever or other discomforts, once a day, 30-40 min/time.
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Primary Completion
May 31, 2021
Actual (reported)Study Completion
June 1, 2023
Actual (reported)Last Updated
July 5, 2023
Record last verified: 2023-06
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Source: ClinicalTrials.gov.
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