Community-Acquired InfectionsPhase 3NCT03185923
Effect of Traditional Chinese Medicine on Outcomes in Patients With Severe Pneumonia
A Phase 3 study testing TCM plus conventional drug in people with Community-Acquired Infections, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study evaluates the integrated traditional Chinese and Western medicine in the treatment of severe community acquired pneumonia in adults. Half of participants will receive traditional Chinese and Western medicine in combination, while the other half will receive a placebo traditional Chinese and Western medicine. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Community-Acquired Infections
- What is being tested?
- TCM plus conventional drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2017to 31 Dec 2020
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- were aged 18 years to 80 years.
- met severe community-acquired pneumonia criteria (defined by modified American Thoracic Society criteria).
- Syndrome differentiation meets criteria of phlegm-heat obstructing in the lung syndrome, pulmonary stagnation of phlegm syndrome, Pathogenic heat trapping the pericardium syndrome, or Pathogenic depression is taking off syndrome.
Who cannot join
- Pregnant and lactating women.
- trauma, hematologic malignancies, various solid tumors, and obstetric complications.
- Aspiration pneumonia, fungal pneumonia, HIV related Pneumocystis carinii pneumonia, tuberculosis, Bronchiectasis with infection and pulmonary abscess;
- Dementia, mental disorders and reluctant partners.
- Be discharged from hospital within 2 days or require operation.
- reported severe immunosupression (human immunodeficiency virus infection, immunosuppressive conditions or medications).
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- Neuromuscular disorders affecting respiratory motor function.
- Patients with severe cardiovascular，with severe liver and kidney disease.
- Patients who have participated in other clinical studies in the past 4 weeks.
- Patients unwilling to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
About this study
Official title: A Randomized Controlled Trial of Integrated Traditional Chinese and Western Medicine in the Treatment of Severe Community Acquired Pneumonia
This study evaluates the integrated traditional Chinese and Western medicine in the treatment of severe community acquired pneumonia in adults. Half of participants will receive traditional Chinese and Western medicine in combination, while the other half will receive a placebo traditional Chinese and Western medicine.
Read the detailed description
Improving the care of patients with community-acquired pneumonia (CAP) has been the focus of many different organizations. Such efforts at improvement in care are warranted, because CAP, especially severe CAP remains the leading cause of death in the world. Despite advances in antimicrobial therapy, rates of mortality due to severe CAP have not decreased significantly since penicillin became routinely available.
traditional Chinese Medicine, has been used for thousands of years in treating pneumonia. To date, it has become popular and widely practiced in many countries around the world. In the past decades, Evidences from both clinicians and patients suggest that there is some beneficial effect of TCM on severe CAP.
At present, there are many therapies available for patients with severe CAP, it is difficult for us to identify the most suitable therapy. Thus, this study aims to compare the efficacy of combination conventional drug and TCM to the conventional drug and placebo, and then determine which one is the better therapy, providing a scientific basis for clinical decision.
This is a multi-center, randomized, controlled trial to compare the efficacy of two therapies for patients with severe CAP. 198 subjects will be randomly assigned to one therapies (conventional drug, and the combination of conventional drug and TCM) for 28 days treatment. After the treatment period, subjects in two arms will be followed up for 12 weeks. The primary outcomes will include treatment failure, and secondary outcomes Time to clinical stability, length hospital stays, in-hospital mortality, SOFA questionnaire, quality of life (CAP-PRO ) and health economics.
- Conditions
- Community-Acquired Infections
- Being tested
- TCM plus conventional drug, TCM placebo plus conventional drug
- Keywords
- Community-Acquired Infections, Humans, Medicine, Chinese Traditional
- Medical subject headings
- Community-Acquired Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM plus conventional drugDrug
All patients were treated with antibiotics according to international guidelines. The Experimental group will receive TCM according to the TCM syndrome.
qingfeijieduhuatan granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for phlegm-heat obstructing in the lung syndrome in 28 treatment days.
zaoshihuatanxiefei granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for pulmonary stagnation of phlegm syndrome in 28 treatment days.
qingxinkaiqiao granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for Pathogenic heat trapping the pericardium syndrome in 28 treatment days.
shenmai injection（Sichuan chuanda west China Pharmaceutical Co., Ltd.）,15ml/ ampulla, 10～60ml each time (when needed), for yin exhausted syndrome in 28 treatment days.
shenfu injection（Sanjiu Medical \& Pharmaceutical Co., Ltd.）,10ml/ ampulla, 50～100ml each time (when needed), for yang exhausted syndrome in 28 treatment days.
TCM placebo plus conventional drugDrug
All patients were treated with antibiotics according to international guidelines. The control group will receive TCM placebo according to the TCM syndrome.
placebo qingfeijieduhuatan granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for phlegm-heat obstructing in the lung syndrome every day in 28 treatment days.
placebo zaoshihuatanxiefei granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for pulmonary stagnation of phlegm syndrome every day in 28 treatment days.
placebo qingxinkaiqiao granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for Pathogenic heat trapping the pericardium syndrome every day in 28 treatment days.
| Study group | Role | What they receive |
|---|---|---|
| TCM plus conventional drug | Experimental | The experimental group will receive three type of TCM inaddition conventional drug according to china CAP guidline 2016. Receives: Drug: TCM plus conventional drug |
| TCM placebo plus conventional drug | Placebo comparator | The control group will receive three type of placebo TCM inaddition conventional drug according to china CAP guidline 2016. Receives: Drug: TCM placebo plus conventional drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
The primary efficacy outcome was the rate of treatment failure, which includes treatment failure that occurred.
Measured: up to 28 days.
Secondary outcomes (6)
time to clinical stability
Clinical stability
Measured: up to 28 days.
length hospital stays
length hospital stays will be recorded.
Measured: up to 28 days.
in-hospital mortality
in-hospital mortality will be recorded.
Measured: up to 28 days.
SOFA questionnaire
Clinical symptom assessment questionnaire of severe CAP
Measured: Change from baseline SOFA score at day 0、7、14、28 of the treatment phase.
CAP -CRO
CAP doctor reported outcome scale will be used to assess symptoms.
Measured: Change from baseline CAP -CRO score at day 0、7、14、28 of the treatment phase.at week 4, week 8, week 12 of the follow-up phase.
Health economics
Cost of the treatment phase will be recorded.
Measured: up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start20 Jun 2017 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-Acquired InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 198 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
- NCT03185923
- Sponsor's protocol ID
- TCM for severe pneumonia
- Status last verified
- Jun 2017
- First submitted
- 4 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang H, Li J, Yu X, Li SY. Integrated traditional Chinese and conventional medicine in treatment of severe community-acquired pneumonia: study protocol for a randomized placebo-controlled trial. Trials. 2018 Nov 12;19(1):620. doi: 10.1186/s13063-018-3005-9.
PubMed 30419961
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Integrated Traditional Chinese and Western Medicine in the Treatment of Severe Community Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT03185923
- Acronym / sponsor ID
- TCM for severe pneumonia
- Conditions
- Community-Acquired Infections
- Keywords
- Community-Acquired Infections, Humans, Medicine, Chinese Traditional
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 20 Jun 2017 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Jun 2017 (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 evaluates the integrated traditional Chinese and Western medicine in the treatment of severe community acquired pneumonia in adults. Half of participants will receive traditional Chinese and Western medicine in combination, while the other half will receive a placebo traditional Chinese and Western medicine.
Detailed description
Improving the care of patients with community-acquired pneumonia (CAP) has been the focus of many different organizations. Such efforts at improvement in care are warranted, because CAP, especially severe CAP remains the leading cause of death in the world. Despite advances in antimicrobial therapy, rates of mortality due to severe CAP have not decreased significantly since penicillin became routinely available.
traditional Chinese Medicine, has been used for thousands of years in treating pneumonia. To date, it has become popular and widely practiced in many countries around the world. In the past decades, Evidences from both clinicians and patients suggest that there is some beneficial effect of TCM on severe CAP.
At present, there are many therapies available for patients with severe CAP, it is difficult for us to identify the most suitable therapy. Thus, this study aims to compare the efficacy of combination conventional drug and TCM to the conventional drug and placebo, and then determine which one is the better therapy, providing a scientific basis for clinical decision.
This is a multi-center, randomized, controlled trial to compare the efficacy of two therapies for patients with severe CAP. 198 subjects will be randomly assigned to one therapies (conventional drug, and the combination of conventional drug and TCM) for 28 days treatment. After the treatment period, subjects in two arms will be followed up for 12 weeks. The primary outcomes will include treatment failure, and secondary outcomes Time to clinical stability, length hospital stays, in-hospital mortality, SOFA questionnaire, quality of life (CAP-PRO ) and health economics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM plus conventional drug | Experimental | Drug: TCM plus conventional drugThe experimental group will receive three type of TCM inaddition conventional drug according to china CAP guidline 2016. |
| TCM placebo plus conventional drug | Placebo comparator | Drug: TCM placebo plus conventional drugThe control group will receive three type of placebo TCM inaddition conventional drug according to china CAP guidline 2016. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- were aged 18 years to 80 years.
- met severe community-acquired pneumonia criteria (defined by modified American Thoracic Society criteria).
- Syndrome differentiation meets criteria of phlegm-heat obstructing in the lung syndrome, pulmonary stagnation of phlegm syndrome, Pathogenic heat trapping the pericardium syndrome, or Pathogenic depression is taking off syndrome.
Key exclusion criteria (10 listed)
- Pregnant and lactating women.
- trauma, hematologic malignancies, various solid tumors, and obstetric complications.
- Aspiration pneumonia, fungal pneumonia, HIV related Pneumocystis carinii pneumonia, tuberculosis, Bronchiectasis with infection and pulmonary abscess;
- Dementia, mental disorders and reluctant partners.
- Be discharged from hospital within 2 days or require operation.
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 |
|---|---|---|
| TCM plus conventional drugAll patients were treated with antibiotics according to international guidelines. The Experimental group will receive TCM according to the TCM syndrome. qingfeijieduhuatan granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for phlegm-heat obstructing in the lung syndrome in 28 treatment days. zaoshihuatanxiefei granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for pulmonary stagnation of phlegm syndrome in 28 treatment days. qingxinkaiqiao granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for Pathogenic heat trapping the pericardium syndrome in 28 treatment days. shenmai injection（Sichuan chuanda west China Pharmaceutical Co., Ltd.）,15ml/ ampulla, 10～60ml each time (when needed), for yin exhausted syndrome in 28 treatment days. shenfu injection（Sanjiu Medical \& Pharmaceutical Co., Ltd.）,10ml/ ampulla, 50～100ml each time (when needed), for yang exhausted syndrome in 28 treatment days. | Drug | TCM plus conventional drug |
| TCM placebo plus conventional drugAll patients were treated with antibiotics according to international guidelines. The control group will receive TCM placebo according to the TCM syndrome. placebo qingfeijieduhuatan granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for phlegm-heat obstructing in the lung syndrome every day in 28 treatment days. placebo zaoshihuatanxiefei granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for pulmonary stagnation of phlegm syndrome every day in 28 treatment days. placebo qingxinkaiqiao granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for Pathogenic heat trapping the pericardium syndrome every day in 28 treatment days. | Drug | TCM placebo plus conventional drug |
Primary outcome
Treatment failure
Time frame: up to 28 days.
The primary efficacy outcome was the rate of treatment failure, which includes treatment failure that occurred.
6 secondary outcomes
time to clinical stability
Time frame: up to 28 days.
length hospital stays
Time frame: up to 28 days.
in-hospital mortality
Time frame: up to 28 days.
SOFA questionnaire
Time frame: Change from baseline SOFA score at day 0、7、14、28 of the treatment phase.
CAP -CRO
Time frame: Change from baseline CAP -CRO score at day 0、7、14、28 of the treatment phase.at week 4, week 8, week 12 of the follow-up phase.
Health economics
Time frame: up to 28 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Derived from this study: PubMed 30419961Wang H, Li J, Yu X, Li SY. Integrated traditional Chinese and conventional medicine in treatment of severe community-acquired pneumonia: study protocol for a randomized placebo-controlled trial. Trials. 2018 Nov 12;19(1):620. doi: 10.1186/s13063-018-3005-9.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TCM plus conventional drug in people with Community-Acquired Infections, 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 3 inclusion and 10 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 14 Jun 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 haifeng wang, doctor (86-371-66248624, wangh_f@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: up to 28 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185923, which also lists 1 linked publication.
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 14 Jun 2017.