Community-acquired PneumoniaNCT04702074
TCM Syndrome Differentiation Treatment on Discharged Elderly Patients With CAP
A study testing Traditional Chinese medicine granules in people with Community-acquired Pneumonia, run by Henan University of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Traditional Chinese medicine granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 292 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jian-sheng Li, Doctor contact
China1 site
the First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, 450000
About this study
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
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.
Read the 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
- Being tested
- Traditional Chinese medicine granules, Traditional Chinese medicine granules placebo
- Keywords
- The discharged elderly patients with CAP, Syndrome differentiation of TCM, Randomized controlled trail
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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 .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Traditional Chinese medicine granules placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalization rate
Rehospitalization and causes of rehospitalization during the study period will be recorded.
Measured: up to month 8.
Secondary outcomes (7)
Mortality
Deaths and causes of death during the study period will be recorded.
Measured: the month1,2 of treatment period and month3, 6 of follow-up period.
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.
Measured: Before treatment, the month 2 of treatment period and month 6 of follow-up period.
MNA-SF
MNA-SF will be used to evaluate the nutritional status.The higher scores will indicate the better nutritional status.
Measured: Before treatment, the month 2 of treatment period and month 3, 6 of follow-up period.
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.
Measured: Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.
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.
Measured: Before treatment, the month 1,2 of treatment period and month3, 6 of follow-up period.
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.
Measured: Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.
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.
Measured: Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start15 Jan 2021 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702074
- Sponsor's protocol ID
- TCM for discharged elderly CAP
- Status last verified
- Jan 2021
- First submitted
- 1 Jan 2021
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04702074
- Acronym / sponsor ID
- TCM for discharged elderly CAP
- Conditions
- Community-acquired Pneumonia
- Keywords
- The discharged elderly patients with CAP, Syndrome differentiation of TCM, Randomized controlled trail
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 8 Jan 2021 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese medicine granules | Experimental | Drug: Traditional Chinese medicine granulesThe 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. |
| Traditional Chinese medicine granules placebo | Placebo comparator | Drug: Traditional Chinese medicine granules placeboThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| Traditional Chinese medicine granulesBu 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. | Drug | Traditional Chinese medicine granules |
| Traditional Chinese medicine granules placeboBu 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 . | Drug | Traditional Chinese medicine granules placebo |
Primary outcome
Rehospitalization rate
Time frame: up to month 8.
Rehospitalization and causes of rehospitalization during the study period will be recorded.
7 secondary outcomes
Mortality
Time frame: the month1,2 of treatment period and month3, 6 of follow-up period.
CURB65 score
Time frame: Before treatment, the month 2 of treatment period and month 6 of follow-up period.
MNA-SF
Time frame: Before treatment, the month 2 of treatment period and month 3, 6 of follow-up period.
CAP-PRO
Time frame: Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.
CAP-CRO
Time frame: Before treatment, the month 1,2 of treatment period and month3, 6 of follow-up period.
SF-36
Time frame: Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.
ESQ-CAP
Time frame: Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
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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. This study is not recruiting at the moment.
Jian-sheng Li, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Chinese medicine granules in people with Community-acquired Pneumonia, run by Henan University of Traditional Chinese Medicine at 1 site in China.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-hang Wang, Doctor (0371-66248624, wmh@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: up to month 8.). 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 8 Jan 2021.