TCM Syndrome Differentiation Treatment on Discharged Elderly Patients With CAP

Community-acquired Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04702074
• Other study ID #: TCM for discharged elderly CAP
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2021
• Source: Henan University of Traditional Chinese Medicine
• Contact: Ming-hang Wang, Doctor
• Phone: 0371-66248624
• Email: wmh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 292
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia
• Syndrome

Intervention

Drug:
• 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.
• 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 .

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Henan University of Chinese Medicine	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Henan University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehospitalization rate	Rehospitalization and causes of rehospitalization during the study period will be recorded.	up to month 8.
Secondary	Mortality	Deaths and causes of death during the study period will be recorded.	the month1,2 of treatment period and month3, 6 of follow-up period.
Secondary	CURB65 score	CURB65 score will be assessd the severity of discharged elderly patients with CAP. 0-1 points: in principle, outpatient treatment is enough; 2 points: hospitalization or out of hospital treatment under strict follow-up; 3-5 points: hospitalization. The higher scores will indicate the worse outcomes.	Before treatment, the month 2 of treatment period and month 6 of follow-up period.
Secondary	MNA-SF	MNA-SF will be used to evaluate the nutritional status.The higher scores will indicate the better nutritional status.	Before treatment, the month 2 of treatment period and month 3, 6 of follow-up period.
Secondary	CAP-PRO	Patient Reported Outcome for CAP scale(CAP-PRO) will be used to evaluate clinical efficacy .The lower scores will indicate the better outcomes.	Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.
Secondary	CAP-CRO	Clinician Reported Outcome for CAP scale(CAP-CRO)will be used to evaluate clinical efficacy . The lower scores will indicate the better outcomes.	Before treatment, the month 1,2 of treatment period and month3, 6 of follow-up period.
Secondary	SF-36	SF-36 will be used to evaluate quality of life with a total of 0-100. The higher scores will indicate the better quality of life.	Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.
Secondary	ESQ-CAP	The efficacy satisfaction questionnaire for CAP (ESQ-CAP) will be used to assess clinical efficacy. The higher scores will indicate the better outcomes.	Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.