NCT04702074

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

January 1, 2021

Last Update Submit

January 7, 2021

Conditions

Community-acquired Pneumonia

Keywords

The discharged elderly patients with CAPSyndrome differentiation of TCMRandomized controlled trail

Outcome Measures

Primary Outcomes (1)

  • Rehospitalization rate

    Rehospitalization and causes of rehospitalization during the study period will be recorded.

    up to month 8.

Secondary Outcomes (7)

  • Mortality

    the month1,2 of treatment period and month3, 6 of follow-up period.

  • CURB65 score

    Before treatment, the month 2 of treatment period and month 6 of follow-up period.

  • MNA-SF

    Before treatment, the month 2 of treatment period and month 3, 6 of follow-up period.

  • CAP-PRO

    Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.

  • CAP-CRO

    Before treatment, the month 1,2 of treatment period and month3, 6 of follow-up period.

  • +2 more secondary outcomes

Study Arms (2)

Traditional Chinese medicine granules

EXPERIMENTAL

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.

Drug: Traditional Chinese medicine granules

Traditional Chinese medicine granules placebo

PLACEBO COMPARATOR

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.

Drug: Traditional Chinese medicine granules placebo

Interventions

Traditional Chinese medicine granulesDRUG

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
Traditional Chinese medicine granules placeboDRUG

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 .

Traditional Chinese medicine granules placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • A confirmed diagnosis of discharged elderly patients with CAP within 1 weeks;
  • 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;
  • Age including or above 65 years old;
  • Voluntary treatment, oral medication;
  • With informed consent signed.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, 450000, China

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Central Study Contacts

Ming-hang Wang, Doctor

CONTACT

0371-66248624wmh@163.com

Jian-sheng Li, Doctor

CONTACT

0371-66248624

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2021

First Posted

January 8, 2021

Study Start

January 15, 2021

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

January 8, 2021

Record last verified: 2021-01

Locations

CN(1)