Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng)
1 other identifier
interventional
324
1 country
4
Brief Summary
This trial aims to evaluate the clinical control rate of sputum by Zhuli Capsule in the treatment of the Phlegm-heat Syndrome （Tan-re Zheng）in the patients with acute exacerbation of chronic obstructive pulmonary disease or chronic bronchitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 chronic-obstructive-pulmonary-disease
Started Jul 2021
Typical duration for phase_4 chronic-obstructive-pulmonary-disease
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2020
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedJune 15, 2021
June 1, 2021
2.3 years
September 21, 2020
June 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The clinical control rate of sputum
Defined as the proportion of patients with the expectoration rate ≥90%.
Day 7
Secondary Outcomes (6)
Time to sputum turn white
up to Day 7
Cough Symptom Score Scale
0,Day 3, Day 7
Use of Antibiotic
0,Day 3, Day 7
Chronic obstructive pulmonary disease Assessment Test
0,Day 3, Day 7
The Phlegm-heat Syndrome (Tan-re Zheng) scale
0,Day 3, Day 7
- +1 more secondary outcomes
Study Arms (2)
Zhuli capsule
EXPERIMENTALBase on the standard medical treatment, the patients in this group will be used Zhuli capsule, 2 capsules (1.2 g) once, three time a day for 7 days.
Placebo
PLACEBO COMPARATORBase on the standard medical treatment, the patients in this group will be used placebo capsule, 2 capsules (1.2 g) once, three time a day for 7 days.
Interventions
This capsule is made from the exact of Phyllostachys glauca McClure or Phyllostachysnuda McClure, which has the expectorant effects. It is oral used,2 capsules for once, three times a day, for 7 days.
The placebo capsule is filled with amylodextrin made with food colour and flavor，with the similar appearance, smell and flavor with Zhuli Capsule. It is oral used, 2 capsules for once, three times a day, for 7 days.
Standard medical treatment will be given according to the recent guidelines with the evaluation of the clinicians, include: 1. if the patient with AECOPD, he or she will be given with oxygen therapy, bronchodilators, glucocorticoid or antibacterial drugs; 2. if the patient with AECB, he or she will be given with antibacterial drugs or anti-asthmatic drugs for asthma attacks.
Eligibility Criteria
You may qualify if:
- Meet the diagnostic criteria of acute exacerbation in chronic obstructive pulmonary disease or chronic bronchitis;
- Meet the diagnostic criteria of Phlegm-heat Syndrome (Tan-re Zheng) in TCM
- Age from 18 to 75 years old, regardless of gender;
- The score of each dimension of the sputum assement scale is ≥1;
- Those who have not participated in other drug clinical research in the past one month;
- Sign the informed consent letter.
You may not qualify if:
- Patients with pulmonary tuberculosis, bronchial cancer or other lung diseases.
- Loose stools due to Spleen deficiency and stomachache caused by cold.
- Diabetes or severe cardiovascular, liver (ALT\>1.5×ULN), kidney (Cr\>1.5×ULN) and other primary diseases.
- Pregnant and lactating women.
- Patients with acute and chronic respiratory failure.
- Those who cannot give full informed consent due to mental disorders.
- People with disabilities recognized by law.
- People with allergies, or allergic to the ingredients of the drug used in this test.
- Those who have used drugs with expectorant effects within the day.
- Patients who are participating in clinical trials of other drugs. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhong Wanglead
Study Sites (4)
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120, China
Sichuan Provincial Hospital of Traditional Chinese Medicine
Chengdu, Sichuan, 610075, China
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, 310006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Institute of Clinical Basic Medicine of Traditional Chinese Medicine
Study Record Dates
First Submitted
September 21, 2020
First Posted
April 8, 2021
Study Start
July 1, 2021
Primary Completion
October 1, 2023
Study Completion
October 1, 2023
Last Updated
June 15, 2021
Record last verified: 2021-06