Treatment of CRF With Syndrome Differentiation of TCM

NCT04694755 | Unknown Early Phase 1 DMC

• 1 other identifier: Treatment of CRF with TCM
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Taking the patients with chronic respiratory failure caused by COPD as the research object and the acute exacerbation of COPD as the main outcome index, the investigators hope to establish the syndrome differentiation and treatment scheme of COPD treated by traditional Chinese medicine, reduce the acute exacerbation of AECOPD, improve the clinical symptoms, improve the quality of life, reduce the mortality, preliminarily explore the mechanism of action, and lay the foundation for further research.

Conditions

Chronic Respiratory Failure

Keywords

COPD; Chronic respiratory failure

Outcome Measures

Primary Outcomes (2)

• Frequency of acute exacerbation

  It will be assessed by frequencies of AECOPD-related hospitalizations.

  Up to week 52.

• Duration of acute exacerbation

  Duration of acute exacerbation will be recorded.

  Up to week 52.

Secondary Outcomes (11)

• All-cause mortality

  up to 52 weeks.

• Dyspnea

  Change from baseline mMRC scores at week 4, 13, 26, 39 and 52.

• COPD assessment test (CAT)

  Change from baseline CAT scores at week 4, 13, 26, 39 and 52.

• Clinical symptoms and Signs

  Change from baseline clinical symptoms assessment questionnaire scores at week 4, 13, 26, 39 and 52.

• Six-minute walking distance(6MWD)

  Change from baseline 6MWD at week 4, 13, 26, 39 and 52

Study Arms (4)

Heart lung qi deficiency syndrome placebo group

PLACEBO COMPARATOR

Buyixinfei placebo was given.Tianjiang brand formula granules were used. One dose a day, two times orally, five days a week.

Drug: Placebo

Deficiency of lung and Kidney Qi placebo group

PLACEBO COMPARATOR

Tonifying kidney and protecting lung prescription placebo was given. Tianjiang brand granule was used as the drug, one dose a day, twice orally, five days a week.

Drug: Placebo

Heart lung qi deficiency syndrome drugs group

EXPERIMENTAL

Buyixinfei formula was given. Tianjiang brand granule was used as the drug, one dose a day, twice orally, five days a week.

Drug: Traditional Chinese medicine prescription

Deficiency of lung and Kidney Qi drugs group

EXPERIMENTAL

The prescription of invigorating the kidney and protecting the lung was given. The drug was Tianjiang brand granule, one dose a day, two times orally, five days a week

Drug: Traditional Chinese medicine prescription

Interventions

Placebo DRUG

On the basis of dextrin and bitter agent, 5% of the drug was used to prepare.Its appearance, weight, color and smell are basically the same as traditional Chinese medicine granule.Tianjiang brand formula granules, in line with GMP standards

Also known as: Placebo for invigorating heart and lung, Tonifying kidney and protecting lung prescription placebo

Deficiency of lung and Kidney Qi placebo group; Heart lung qi deficiency syndrome placebo group

Traditional Chinese medicine prescription DRUG

Tianjiang brand formula granules, in line with GMP standards

Also known as: Tonic heart and lung prescription, Prescription for tonifying kidney and protecting lung

Deficiency of lung and Kidney Qi drugs group; Heart lung qi deficiency syndrome drugs group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who meet the diagnostic criteria of COPD in stable stage;
• patients whose blood gas analysis meets PaO2 \< 60mmhg and / or PaCO2 \> 50mmhg in calm breathing at sea level;
• patients whose syndrome differentiation meets the syndrome of heart lung qi deficiency and lung kidney qi deficiency;
• patients whose age is ≥ 40 years and ≤ 80 years;
• patients who are willing to receive treatment and sign the informed consent.

You may not qualify if:

• chronic respiratory failure caused by bronchial asthma, bronchiectasis, cystic pulmonary fibrosis, lung cancer and other respiratory diseases;
• acute aggravation of the original chronic respiratory failure;
• patients with tumor, serious cardiovascular and cerebrovascular diseases (acute myocardial infarction, cardiac function level 3 and above, stroke, cerebral hemorrhage, etc.) and serious liver and kidney diseases (serious liver disease refers to liver cirrhosis, portal hypertension and varicose bleeding, and serious kidney disease includes dialysis and kidney transplantation) and other people who cannot participate in clinical research;
• pregnant and lactating women;
• patients with mental diseases and mental disorders;
• those who are participating in clinical trials of other drugs, known to be allergic to treatment drugs.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Prescriptions

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Minghang Wang, doctor

  The First Affiliated Hospital of Henan University of Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Minghang Wang, doctor

CONTACT

18638392188; wmh107hn@163.com

Suyun Li, doctor

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: It is jointly completed by the person in charge of the project, the drug preparation personnel and the statistician, and the two-level blind method is adopted. Blinding at the first level: that is to say, blinding is set for experimental Chinese medicine. The test drug and the control drug shall be packed uniformly; the second level shall be provided with blindness, that is, the number of the test drug packaging box shall be provided with blindness.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The experimental group was given TCM syndrome differentiation treatment granules, heart and lung qi deficiency was given invigorating heart and lung formula, lung and kidney qi deficiency was given invigorating kidney and protecting lung formula; the control group was given TCM syndrome differentiation treatment placebo.

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 5, 2021
• Study Start: January 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 6, 2021

Record last verified: 2020-08