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Effect of Traditional Chinese Medicine on Outcomes in Patients With Severe Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03185923
Recruitment Status : Unknown
Verified June 2017 by Henan University of Traditional Chinese Medicine.
Recruitment status was:  Not yet recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Henan University of Traditional Chinese Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Community-Acquired Infections Drug: TCM plus conventional drug Drug: TCM placebo plus conventional drug Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Integrated Traditional Chinese and Western Medicine in the Treatment of Severe Community Acquired Pneumonia
Estimated Study Start Date : June 20, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: TCM plus conventional drug
The experimental group will receive three type of TCM inaddition conventional drug according to china CAP guidline 2016.
Drug: TCM plus conventional drug

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.


Placebo Comparator: TCM placebo plus conventional drug
The control group will receive three type of placebo TCM inaddition conventional drug according to china CAP guidline 2016.
Drug: TCM placebo plus conventional drug

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.





Primary Outcome Measures :
  1. Treatment failure [ Time Frame: up to 28 days. ]
    The primary efficacy outcome was the rate of treatment failure, which includes treatment failure that occurred.


Secondary Outcome Measures :
  1. time to clinical stability [ Time Frame: up to 28 days. ]
    Clinical stability

  2. length hospital stays [ Time Frame: up to 28 days. ]
    length hospital stays will be recorded.

  3. in-hospital mortality [ Time Frame: up to 28 days. ]
    in-hospital mortality will be recorded.

  4. SOFA questionnaire [ Time Frame: Change from baseline SOFA score at day 0、7、14、28 of the treatment phase. ]
    Clinical symptom assessment questionnaire of severe CAP

  5. 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. ]
    CAP doctor reported outcome scale will be used to assess symptoms.

  6. Health economics [ Time Frame: up to 28 days. ]
    Cost of the treatment phase will be recorded.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185923


Contacts
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Contact: haifeng wang, doctor 86-371-66248624 wangh_f@126.com
Contact: jiangsheng li, doctor 86-371-66248624 li_js8@163.com

Locations
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China, Henan
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China, 450000
Sponsors and Collaborators
Henan University of Traditional Chinese Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Henan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03185923    
Other Study ID Numbers: TCM for severe pneumonia
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Henan University of Traditional Chinese Medicine:
Community-Acquired Infections
Humans
Medicine, Chinese Traditional
Additional relevant MeSH terms:
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Community-Acquired Infections
Pneumonia
Infection
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections