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

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.

Study Overview

• Status: Unknown
• Conditions: Community-Acquired Infections
• Intervention / Treatment: Drug: TCM plus conventional drug; Drug: TCM placebo plus conventional drug

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 Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: haifeng wang, doctor; Phone Number: 86-371-66248624; Email: wangh_f@126.com
• Study Contact Backup: Name: jiangsheng li, doctor; Phone Number: 86-371-66248624; Email: li_js8@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment failure	The primary efficacy outcome was the rate of treatment failure, which includes treatment failure that occurred.	up to 28 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to clinical stability	Clinical stability	up to 28 days.
length hospital stays	length hospital stays will be recorded.	up to 28 days.
in-hospital mortality	in-hospital mortality will be recorded.	up to 28 days.
SOFA questionnaire	Clinical symptom assessment questionnaire of severe CAP	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.	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.	up to 28 days.

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 20, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: June 4, 2017
• First Submitted That Met QC Criteria: June 11, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 11, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Humans; Medicine, Chinese Traditional; Community-Acquired Infections
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Community-Acquired Infections
• Other Study ID Numbers: TCM for severe pneumonia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No