Clinical trial NCT04702074: TCM Syndrome Differentiation Treatment on Discharged Elderly Patients With CAP
Official title: TCM Syndrome Differentiation Treatment on Reducing the Rehospitalization Rate of Discharged Elderly Patients With CAP:A Multi-center, Randomized, Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Community-acquired Pneumonia
Keywords: The discharged elderly patients with CAP
Syndrome differentiation of TCM
Randomized controlled trail
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 292
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the efficacy and safety of TCM syndrome differentiation treatment on the rehospitalization rate of discharged elderly patients with community acquired pneumonia(CAP)and to explore its mechanism.

Detailed description: The incidence and mortality of elderly patients with CAP are on a rising trend, especially the mortality of those over 65 years old are the highest. The elderly patients with CAP have more complications and drug resistance, which makes it difficult to treat and have heavy burden on the society. The discharged elderly patients with CAP are still facing the risk of readmission or even death due to recurrent pneumonia or other reasons. Research reports showed that TCM syndrome differentiation treatment had a certain role in improving the condition of discharged elderly patients with CAP. Our previous exploratory studies suggested that TCM syndrome differentiation treatment on the discharged elderly patients with CAP had good clinical efficacy and safety.

This is a multi-center, randomized, double-blind, placebo controlled trial to evaluate the efficacy and safety of TCM syndrome differentiation on the rehospitalization rate of discharged elderly patients with CAP and to explore its mechanism. 292 patients will be randomly assigned in a 1:1 ratio to experimental group or control group for 2 months treatment and 6 months follow-up.The experimental group will be given by Bu Fei Jian Pi Hua Tan granule or Yi Qi Yang Yin Qing Fei granule based on TCM syndrome differentiation. The primary outcomes are rehospitalization rate. The secondary outcomes include mortality, assessment of disease severity(CURB65 scores),quality of life (SF-36), treatment satisfaction(ESQ-CAP),Clinician Reported Outcome for CAP,Patient Reported Outcome for CAP,nutritional status (MNA-SF).

Eligibility criteria: Inclusion Criteria:

1. A confirmed diagnosis of discharged elderly patients with CAP within 1 weeks;
2. Syndrome differentiation meets criteria of syndrome of the lung and spleen qi deficiency and unclean phlegm dampness, Syndrome of qi and yin deficiency and unclean phlegm heat;
3. Age including or above 65 years old;
4. Voluntary treatment, oral medication;
5. With informed consent signed.

Exclusion Criteria:

1. A confirmed diagnosis of discharged elderly patients with severe CAP;
2. Patients with unconscious, dementia or mental disorders;
3. Patients with hydrothorax, bronchiectasis, active pulmonary tuberculosis, pulmonary abscess, chronic obstructive pulmonary disease of GOLD D;
4. Patients with aspiration risk of severe neuromuscular disorders and long-term bedridden;
5. Patients with tumor, severe cardiovascular disease and severe liver and kidney diseases;
6. Participants in clinical trials of other drugs;
7. People who are allergic to the treatment drugs.

Primary outcomes:
measure: Rehospitalization rate
timeFrame: up to month 8.
Secondary outcomes:
measure: Mortality
timeFrame: the month1,2 of treatment period and month3, 6 of follow-up period.
measure: CURB65 score
timeFrame: Before treatment, the month 2 of treatment period and month 6 of follow-up period.
measure: MNA-SF
timeFrame: Before treatment, the month 2 of treatment period and month 3, 6 of follow-up period.
measure: CAP-PRO
timeFrame: Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.
measure: CAP-CRO
timeFrame: Before treatment, the month 1,2 of treatment period and month3, 6 of follow-up period.
measure: SF-36
timeFrame: Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.
measure: ESQ-CAP
timeFrame: Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: the First Affiliated Hospital of Henan University of Chinese Medicine
Study officials:
References: