PneumoniaNCT06220019
REspiratory diSEAse cohoRt Studies of CHinese Medicine for Pneumonia (RESEARCH-Pneumonia)
An observational study of Pneumonia, run by Henan University of Traditional Chinese Medicine.
Trial summary
The purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with pneumonia after discharge in a prospective cohort study: one is the Traditional Chinese Medicine (TCM) cohort, which has been evaluated and has certain effects; The other is a non traditional Chinese… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- TCM
- Type of treatment
- Pill or oral medicine
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 26 Dec 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients discharged after pneumonia.
Who may be able to join
None listed.
Who cannot join
- Patients with confusion, consciousness disorders, dementia, and various mental illnesses;
- Patients with altered mental status, dementia, consciousness disorders, or various psychiatric conditions;
- Those who are completely unable to care for themselves or are bedridden long-term; and those currently participating in other clinical drug trials.
- Known to be allergic to treatment drugs.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with pneumonia after discharge in a prospective cohort study: one is the Traditional Chinese Medicine (TCM) cohort, which has been evaluated and has certain effects; The other is a non traditional Chinese medicine queue.
Read the detailed description
The incidence, hospitalization rate, and mortality associated with pneumonia are significant, contributing to a substantial disease burden. Post-discharge follow-up and intervention strategies for pneumonia patients are often insufficient, leaving patients vulnerable to readmission or mortality due to recurrent pneumonia and related complications. In clinical practice, there is a predominant focus on the amelioration of clinical symptoms during hospitalization, with limited attention to ongoing outpatient interventions aimed at reducing readmission rates. Consequently, there is a pressing need for cohort studies on pneumonia.
This study is a multicenter, prospective cohort study involving adult patients discharged after pneumonia treatment. Approximately 5,000 patients will be enrolled, with follow-up assessments conducted every three months over the course of one year. After one year, patients will be stratified into two cohorts based on the duration of Traditional Chinese medicine (TCM) treatment received (e.g., continuous treatment for two months or intermittent treatment for three months per year). One cohort will consist of patients receiving TCM, while the other will include those who did not receive TCM. The primary endpoint is the rate of hospital readmission, while secondary outcomes include treatment satisfaction, physician-reported outcomes, patient-reported outcomes, quality of life, nutritional status, incidence of acute upper respiratory tract infections, and survival. This study aims to evaluate the clinical efficacy and safety of TCM in the management of adult pneumonia patients following discharge.
- Conditions
- Pneumonia
- Being tested
- TCM
- Keywords
- Pneumonia, Chinese Medicine, Cohort
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCMDrug
We will perform subgroup analyses based on specific TCM interventions (such as Chinese patent medicines or external therapies) and the duration of TCM treatment (for example, comparing patients who receive continuous oral Chinese patent medicine for two months or more each year with those who do not). These analyses will assess the efficacy and safety of TCM.
| Study group | Role | What they receive |
|---|---|---|
| TCM Group | The study will include adult patients discharged after hospitalization for pneumonia, with no restrictions on TCM syndromes. Patients diagnosed with pneumonia via laboratory or imaging tests at admission and treated in the hospital will be eligible if enrolled within seven days of discharge. Follow-ups will occur every three months over one year, documenting treatment methods (TCM or Western medicine), hospitalizations, respiratory infections, mortality, and quality of life.
Subgroup analyses will be conducted based on age, type of pneumonia (community- or hospital-acquired), specific TCM treatments (e.g., Chinese patent medicines or external therapies), and treatment duration. Receives: Drug: TCM | |
| Non-TCM Group | All patients who do not meet the defined criteria for the TCM group will be classified into the non-TCM group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalization rate
Including all-cause readmission rate and pulmonary infection readmission rate
Measured: The Rehospitalization rate within a one-year follow-up period
Secondary outcomes (7)
Patient satisfaction with efficacy
The Effectiveness Satisfaction Questionnaire of CAP (ESQ-CAP) was used to evaluate the efficacy of pneumonia patients.
Measured: Changes in ESQ-COPD relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Health survey summary table（SF-36）
Using SF-36 to evaluate the impact of CAP on a person's life over time
Measured: Changes in SF-36 relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Clinical outcomes reported by patients
The Patient Reported Outcome for CAP (CAP-PRO) was used to assess the quality of life and health status of patients with pneumonia.
Measured: Changes in CAP-PRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Clinical outcomes reported by doctors
The Clinical Reported Outcome for CAP (CAP CRO) was used to assess the patient's condition.
Measured: Changes in CAP-CRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
nutritional status
Nutritional status related indicators.
Measured: Changes in nutritional status of CAP patients relative to baseline at 6 and 12 months of follow-up stage
Acute upper respiratory tract infection (URTI) event
It is a general term for acute inflammation of the nose, pharynx, or throat caused by various viruses and/or bacteria, including common cold, acute viral pharyngitis or laryngitis, acute herpetic pharyngitis, pharyngoconjunctival fever, bacterial pharyngitis, and tonsillitis.
Measured: Acute upper respiratory tract infection events that occurred during the one-year follow-up period
Survival situation
Record the number of deaths. Record the follow-up period every 3 months.
Measured: Changes in patient survival situation relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start26 Dec 2024 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan No.1 Hospital, Hebei Provincial Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Qingdao Hiser Medical Group, The First Affiliated Hospital of Zhejiang Chinese Medical University, Shaanxi Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Jiansheng Li, Doctor, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220019
- Sponsor's protocol ID
- RESEARCH-Pneumonia
- Status last verified
- Sep 2024
- First submitted
- 5 Jan 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REspiratory diSEAse cohoRt Studies of CHinese Medicine for Pneumonia (RESEARCH-Pneumonia)
- ClinicalTrials.gov ID
- NCT06220019
- Acronym / sponsor ID
- RESEARCH-Pneumonia
- Conditions
- Pneumonia
- Keywords
- Pneumonia, Chinese Medicine, Cohort
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Wuhan No.1 Hospital, Hebei Provincial Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Qingdao Hiser Medical Group, The First Affiliated Hospital of Zhejiang Chinese Medical University, Shaanxi Hospital of Traditional Chinese Medicine
- Study start
- 26 Dec 2024 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with pneumonia after discharge in a prospective cohort study: one is the Traditional Chinese Medicine (TCM) cohort, which has been evaluated and has certain effects; The other is a non traditional Chinese medicine queue.
Detailed description
The incidence, hospitalization rate, and mortality associated with pneumonia are significant, contributing to a substantial disease burden. Post-discharge follow-up and intervention strategies for pneumonia patients are often insufficient, leaving patients vulnerable to readmission or mortality due to recurrent pneumonia and related complications. In clinical practice, there is a predominant focus on the amelioration of clinical symptoms during hospitalization, with limited attention to ongoing outpatient interventions aimed at reducing readmission rates. Consequently, there is a pressing need for cohort studies on pneumonia.
This study is a multicenter, prospective cohort study involving adult patients discharged after pneumonia treatment. Approximately 5,000 patients will be enrolled, with follow-up assessments conducted every three months over the course of one year. After one year, patients will be stratified into two cohorts based on the duration of Traditional Chinese medicine (TCM) treatment received (e.g., continuous treatment for two months or intermittent treatment for three months per year). One cohort will consist of patients receiving TCM, while the other will include those who did not receive TCM. The primary endpoint is the rate of hospital readmission, while secondary outcomes include treatment satisfaction, physician-reported outcomes, patient-reported outcomes, quality of life, nutritional status, incidence of acute upper respiratory tract infections, and survival. This study aims to evaluate the clinical efficacy and safety of TCM in the management of adult pneumonia patients following discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM Group | – | Drug: TCMThe study will include adult patients discharged after hospitalization for pneumonia, with no restrictions on TCM syndromes. Patients diagnosed with pneumonia via laboratory or imaging tests at admission and treated in the hospital will be eligible if enrolled within seven days of discharge. Follow-ups will occur every three months over one year, documenting treatment methods (TCM or Western medicine), hospitalizations, respiratory infections, mortality, and quality of life. Subgroup analyses will be conducted based on age, type of pneumonia (community- or hospital-acquired), specific TCM treatments (e.g., Chinese patent medicines or external therapies), and treatment duration. |
| Non-TCM Group | – | –All patients who do not meet the defined criteria for the TCM group will be classified into the non-TCM group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients discharged after pneumonia.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patients with confusion, consciousness disorders, dementia, and various mental illnesses;
- Patients with altered mental status, dementia, consciousness disorders, or various psychiatric conditions;
- Those who are completely unable to care for themselves or are bedridden long-term; and those currently participating in other clinical drug trials.
- Known to be allergic to treatment drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCMWe will perform subgroup analyses based on specific TCM interventions (such as Chinese patent medicines or external therapies) and the duration of TCM treatment (for example, comparing patients who receive continuous oral Chinese patent medicine for two months or more each year with those who do not). These analyses will assess the efficacy and safety of TCM. | Drug | TCM Group |
Primary outcome
Rehospitalization rate
Time frame: The Rehospitalization rate within a one-year follow-up period
Including all-cause readmission rate and pulmonary infection readmission rate
7 secondary outcomes
Patient satisfaction with efficacy
Time frame: Changes in ESQ-COPD relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Health survey summary table（SF-36）
Time frame: Changes in SF-36 relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Clinical outcomes reported by patients
Time frame: Changes in CAP-PRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Clinical outcomes reported by doctors
Time frame: Changes in CAP-CRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
nutritional status
Time frame: Changes in nutritional status of CAP patients relative to baseline at 6 and 12 months of follow-up stage
Acute upper respiratory tract infection (URTI) event
Time frame: Acute upper respiratory tract infection events that occurred during the one-year follow-up period
Survival situation
Time frame: Changes in patient survival situation relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiansheng Li, Doctor study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by Henan University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minghang Wang, Doctor (+86 371 66248624, wmh107hn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehospitalization rate (time frame: The Rehospitalization rate within a one-year follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.