Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion

• Sponsor: Zhang Zhijie (Other)
• Overall Status: Completed
• CT.gov ID: NCT06143358
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.1
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

Through the clinical observation of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease (phlegm-heat lung syndrome), (1) to evaluate the safety of Qingcheng Pingxian Granules in the acute exacerbation of chronic obstructive pulmonary disease; (2) to observe the clinical efficacy of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease, to provide an effective medication and solution for the treatment of acute exacerbation of chronic obstructive pulmonary disease, and to provide data for the development of the further application of Qingcheng Pingxian Granules.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Qingkepingchuan Granules; Other: conventional treatment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Qingkepingchuan GranulesQingkepingchuan Granules
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion
• Actual Study Start Date: Jan 1, 2022
• Actual Primary Completion Date: Jul 7, 2023
• Actual Study Completion Date: Jul 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment group Qingkepingchuan Granules+Conventional basic therapy	Drug: Qingkepingchuan Granules; Qingkepingchuan Granules,Take it three times a day with water after meals.
Other: control subjects Conventional basic therapy	Other: conventional treatment; Oxygen intake, selection of appropriate antibiotics based on lab results, and other treatments

Outcome Measures

Primary Outcome Measures

1. Chinese Medicine Symptoms Scale [Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up]

   Record changes in patients' TCM indicators。The scale includes cough, wheezing, shortness of breath, sputum volume, chest tightness, sputum colour, sputum quality, fever, thirst, irritability, constipation, tongue coating, and pulse. The first four items are rated 0-6, and the last nine items are rated 0-3, with higher ratings indicating poorer treatment outcomes.

2. COPD assessment test [Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up]

   Record changes in the patient's condition

3. breathlessness measurement using the modified British Medical Research Council [Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up]

   Record changes in the patient's condition

Secondary Outcome Measures

1. 6-minute walking test [Before the start of treatment, 2 weeks of treatment]

   Record changes in the patient's condition

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Meet the diagnostic criteria of AECOPD.

2. Chinese medicine diagnosis is consistent with phlegm-heat and lung depletion evidence

3. 40 years old ≤ age ≤ 90 years old

4. Patients who signed the informed consent form and volunteered to participate in the study

Exclusion Criteria:

1. Combined with other primary lung diseases such as bronchial asthma, bronchiectasis, etc.

2. Combination of serious cardiovascular, urinary, digestive, haematopoietic, endocrine metabolic system diseases, other psychiatric and neurological diseases.

3. Pregnant or lactating patients.

4. Allergic to the clinical trial drugs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing University of Chinese Medicine	Beijing		China

Sponsors and Collaborators

• Zhang Zhijie

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhang Zhijie, PhD, Beijing University of Chinese Medicine
• ClinicalTrials.gov Identifier: NCT06143358
• Other Study ID Numbers: SY-1
• First Posted: Nov 22, 2023
• Last Update Posted: Nov 24, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Nov 24, 2023