TCM Syndrome Differentiation Treatment on Discharged Elderly Patients With CAP

Henan University of Traditional Chinese Medicine

Status: Unknown

Conditions: Community-acquired Pneumonia

Treatments: Drug: Traditional Chinese medicine granules; Drug: Traditional Chinese medicine granules placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04702074

TCM for discharged elderly CAP

Details and patient eligibility

About

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.

Full 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).

Enrollment: 292 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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292 participants in 2 patient groups, including a placebo group

Traditional Chinese medicine granules

Experimental group

Description:

The experimental group will be given Bu Fei Jian Pi Hua Tan granule or Yi Qi Yang Yin Qing Fei granule based on TCM syndrome differentiation.

Treatment:

Drug: Traditional Chinese medicine granules

Traditional Chinese medicine granules placebo

Placebo Comparator group

Description:

The control group will be given Bu Fei Jian Pi Hua Tan granule placebo or Yi Qi Yang Yin Qing Fei granule placebo based on TCM syndrome differentiation.

Treatment:

Drug: Traditional Chinese medicine granules placebo