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

NCT03185923 | Unknown Phase 3 DMC

• 1 other identifier: TCM for severe pneumonia
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Community-Acquired Infections

Keywords

Community-Acquired Infections; Humans; Medicine, Chinese Traditional

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  The primary efficacy outcome was the rate of treatment failure, which includes treatment failure that occurred.

  up to 28 days.

Secondary Outcomes (6)

• time to clinical stability

  up to 28 days.

• length hospital stays

  up to 28 days.

• in-hospital mortality

  up to 28 days.

• SOFA questionnaire

  Change from baseline SOFA score at day 0、7、14、28 of the treatment phase.

• CAP -CRO

  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.

Study Arms (2)

TCM plus conventional drug

EXPERIMENTAL

The experimental group will receive three type of TCM inaddition conventional drug according to china CAP guidline 2016.

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.

Drug: TCM placebo plus conventional drug

Interventions

TCM plus conventional drug 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.

TCM plus conventional drug

TCM placebo plus conventional drug 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.

TCM placebo plus conventional drug

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Study Sites (1)

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

Location

Related Publications (1)

• 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.

  PMID: 30419961 DERIVED

MeSH Terms

Conditions

Community-Acquired Infections

Condition Hierarchy (Ancestors)

Infections

Central Study Contacts

haifeng wang, doctor

CONTACT

86-371-66248624; wangh_f@126.com

jiangsheng li, doctor

CONTACT

86-371-66248624; li_js8@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2017
• First Posted: June 14, 2017
• Study Start: June 20, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)