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Effects of Traditional Chinese Medicine on AECOPD Patients

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ClinicalTrials.gov Identifier: NCT03428412
Recruitment Status : Not yet recruiting
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Henan University of Traditional Chinese Medicine

Brief Summary:
This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy of two therapies for patients with AECOPD. 378 subjects will be randomly assigned to one therapies (conventional drug, and the combination of conventional drug and TCM) for 14 days treatment. After the treatment period, subjects in two arms will be followed up for 4 weeks. The primary outcomes will include COPD Assessment Test (CAT), and secondary outcomes include treatment failure rate, treatment success rate, hospitalization time, hospital admission rate, endotracheal intubation rate, mortality and quality of life (COPD-PRO, SF-36).

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Acute Exacerbation Medicine, Chinese Traditional Drug: TCM and conventional drug Drug: TCM placebo and conventional drug Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Traditional Chinese Medicine on AECOPD Patients: A Multi-center, Randomized, Double-blind, Controlled Trial
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: TCM plus conventional drug
The experimental group will receive three type of TCM in addition conventional drug according to 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.
Drug: TCM and conventional drug

All patients were treated with medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.

The Experimental group will receive TCM according to the TCM syndrome. Sanhanhuayin granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of external cold and internal fluid in 14 treatment days.

Qingrehuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-heat congesting lung in 14 treatment days.

Zaoshihuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-damp amassing in lung in 14 treatment days.


Placebo Comparator: TCM placebo plus conventional drug
The control group will receive three type of placebo TCM in addition conventional drug according to 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.
Drug: TCM placebo and conventional drug

All patients were treated with medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.

The control group will receive TCM placebo according to the TCM syndrome. Placebo Sanhanhuayin granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of external cold and internal fluid in 14 treatment days.

Placebo Qingrehuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-heat congesting lung in 14 treatment days.

Placebo Zaoshihuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-damp amassing in lung in 14 treatment days.





Primary Outcome Measures :
  1. COPD Assessment Test(CAT) [ Time Frame: Change from baseline CAT score at day 0, 14 of the treatment phase, at day 14, 28 of the follow-up phase. ]
    Using COPD Assessment Test ( CAT) to asses the impact of AECOPD on a person's life, and how this changes over time.


Secondary Outcome Measures :
  1. Treatment failure rate [ Time Frame: The numbers of treatment failure at day 14 of the treatment phase. ]
  2. Treatment success rate [ Time Frame: The numbers of treatment success at day 14 of the treatment phase. ]
  3. Length of hospital stays [ Time Frame: The length hospital stays in 14 Days of the treatment phase ]
    length hospital stays will be recorded.

  4. Readmission due to AECOPD [ Time Frame: The numbers of readmission due to AECOPD in 28 Days of the followup phase. ]
    Readmission due to AECOPD will be recorded.

  5. Intubation rate [ Time Frame: The numbers of intubation at day 4,7,10,14 of the treatment phase, at day 14, 28 of the follow-up phase. ]
    Intubation will be recorded.

  6. Mortality [ Time Frame: The numbers of mortality at day 14 of the treatment phase and day 28 of the follow-up phase. ]
  7. Dyspnea [ Time Frame: Change from Baseline in the mMRC at day 0, 4, 7, 10,14 of the treatment phase, at day 14, 28 of the follow-up phase. ]
    Using modified Medical Research Council (mMRC) to asses the dyspnea of COPD, and how this changes over time.

  8. SF-36 [ Time Frame: Change from Baseline in the SF-36 at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase. ]
    Using the MOS item short from health survey (SF-36) to asses the impact of COPD on a person's life, and how this changes over time.

  9. COPD-PRO [ Time Frame: Change from Baseline in the COPD-PRO at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase. ]
    Using the COPD patient reported outcome scale (COPD-PRO) to asses the impact of COPD on a person's life, and how this changes over time.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A confirmed diagnosis of moderate to very severe AECOPD
  • Age between 40 and 80 years
  • Syndrome differentiation meets criteria of syndrome of external cold and internal fluid,syndrome of phlegm-heat congesting lung,or syndrome of phlegm-damp amassing in lung
  • Without participations in other interventional trials in the previous one month
  • With the informed consent signed

Exclusion Criteria:

  • Pregnant and lactating women
  • Dementia, mental disorders and reluctant partners
  • Complicated with heart failure (NYHA Class IV), or Serious cardiac arrhythmias, or unstable hemodynamics
  • Current respiratory disorders other than COPD (e.g., bronchiectasis, active tuberculosis, pneumothorax, Pleural effusion, pulmonary thromboembolic, or Neuromuscular diseases affect respiratory movement function)
  • Combined tumor
  • Treated outside the hospital for more than 7 days
  • Need to carry out invasive mechanical ventilation respiratory failure
  • Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation)
  • Bedridden for various reasons
  • Allergic to the used medicine

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): NCT03428412


Contacts
Contact: Hailong Zhang, doctor 86-371-66248624 zhanghailong6@126.com
Contact: Jiansheng Li, doctor 86-371-66248624 li_js8@163.com

Sponsors and Collaborators
Henan University of Traditional Chinese Medicine

Responsible Party: Henan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03428412     History of Changes
Other Study ID Numbers: TCM for AECOPD
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Chronic Obstructive Pulmonary Disease
Acute exacerbation
Traditional Chinese medicine

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive