TCM Syndrome Differentiation Treatment on Discharged Elderly Patients With CAP

NCT ID: NCT04702074

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2022-12-30

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).

Conditions

Community-acquired Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Traditional Chinese medicine granules

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.

Group Type: EXPERIMENTAL

Traditional Chinese medicine granules

Intervention Type: DRUG

Bu Fei Jian Pi Hua Tan granule for syndrome of the lung and spleen qi deficiency and unclean phlegm dampness.

Yi Qi Yang Yin Qing Fei granule for syndrome of qi and yin deficiency and unclean phlegm heat.

Traditional Chinese medicine granules will be administered twice daily for 2 months.

Traditional Chinese medicine granules placebo

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.

Group Type: PLACEBO_COMPARATOR

Traditional Chinese medicine granules placebo

Intervention Type: DRUG

Bu Fei Jian Pi Hua Tan granule placebo for syndrome of the lung and spleen qi deficiency and unclean phlegm dampness.

Yi Qi Yang Yin Qing Fei granule placebo for Syndrome of qi and yin deficiency and unclean phlegm heat.

Traditional Chinese medicine granules placebo will be administered twice daily for 2 months.

The appearance, weight, color and odor of the preparation are the same as those of experimental group.

The granule placebo consists of dextrin, bitter and 5% of the Traditional Chinese medicine granules .

Interventions

Traditional Chinese medicine granules

Bu Fei Jian Pi Hua Tan granule for syndrome of the lung and spleen qi deficiency and unclean phlegm dampness.

Yi Qi Yang Yin Qing Fei granule for syndrome of qi and yin deficiency and unclean phlegm heat.

Traditional Chinese medicine granules will be administered twice daily for 2 months.

Intervention Type: DRUG

Traditional Chinese medicine granules placebo

Bu Fei Jian Pi Hua Tan granule placebo for syndrome of the lung and spleen qi deficiency and unclean phlegm dampness.

Yi Qi Yang Yin Qing Fei granule placebo for Syndrome of qi and yin deficiency and unclean phlegm heat.

Traditional Chinese medicine granules placebo will be administered twice daily for 2 months.

The appearance, weight, color and odor of the preparation are the same as those of experimental group.

The granule placebo consists of dextrin, bitter and 5% of the Traditional Chinese medicine granules .

Intervention Type: DRUG

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, , China

Countries

China

Central Contacts

Ming-hang Wang, Doctor

Role: CONTACT

wmh@163.com

0371-66248624

Jian-sheng Li, Doctor

Role: CONTACT

0371-66248624

Other Identifiers

TCM for discharged elderly CAP

Identifier Type: -

Identifier Source: org_study_id