Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng) in the Acute Exacerbations of Chronic Obstructive Pulmonary Disease or Chronic Bronchitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04834531
• Other study ID #: ZLJN-V2.0
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2021
• Est. completion date: October 2023

Study information

• Verified date: June 2021
• Source: China Academy of Chinese Medical Sciences
• Contact: Zhong Wang, M.D.
• Phone: 86-10-64093207
• Email: zhonw[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 324
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Meet the diagnostic criteria of acute exacerbation in chronic obstructive pulmonary disease or chronic bronchitis;

2. Meet the diagnostic criteria of Phlegm-heat Syndrome (Tan-re Zheng) in TCM

3. Age from 18 to 75 years old, regardless of gender;

4. The score of each dimension of the sputum assement scale is =1;

5. Those who have not participated in other drug clinical research in the past one month;

6. Sign the informed consent letter.

Exclusion Criteria:

1. Patients with pulmonary tuberculosis, bronchial cancer or other lung diseases.

2. Loose stools due to Spleen deficiency and stomachache caused by cold.

3. Diabetes or severe cardiovascular, liver (ALT>1.5×ULN), kidney (Cr>1.5×ULN) and other primary diseases.

4. Pregnant and lactating women.

5. Patients with acute and chronic respiratory failure.

6. Those who cannot give full informed consent due to mental disorders.

7. People with disabilities recognized by law.

8. People with allergies, or allergic to the ingredients of the drug used in this test.

9. Those who have used drugs with expectorant effects within the day.

10. Patients who are participating in clinical trials of other drugs. -

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Zhuli capsule
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.
• Placebo
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.

Other:
• Standard medical treatment
Standard medical treatment will be given according to the recent guidelines with the evaluation of the clinicians, include: if the patient with AECOPD, he or she will be given with oxygen therapy, bronchodilators, glucocorticoid or antibacterial drugs; if the patient with AECB, he or she will be given with antibacterial drugs or anti-asthmatic drugs for asthma attacks.

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Sichuan Provincial Hospital of Traditional Chinese Medicine	Chengdu	Sichuan
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
China	Zhejiang Provincial Hospital of Chinese Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhong Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clinical control rate of sputum	Defined as the proportion of patients with the expectoration rate =90%.	Day 7
Secondary	Time to sputum turn white		up to Day 7
Secondary	Cough Symptom Score Scale	Cough Symptom Score Scale include Day Cough Symptom Score and Night cough symptom score. In Day Cough Symptom Score, zero means no cough,one means occasionally short cough,two means frequent cough, slightly affecting daily activities,three means frequent coughing seriously affects daily activities;In Night cough symptom score,zero means no cough,one means short-term cough when falling asleep or occasional night cough,two means cough slightly affects night sleep,three means cough seriously affects night sleep.	0,Day 3, Day 7
Secondary	Use of Antibiotic		0,Day 3, Day 7
Secondary	Chronic obstructive pulmonary disease Assessment Test		0,Day 3, Day 7
Secondary	The Phlegm-heat Syndrome (Tan-re Zheng) scale	The Phlegm-heat Syndrome (Tan-re Zheng) scale include measures of the main symptoms and the secondary symptoms. The main symptom is about the color ,the characteristics and the amount of sputum.Each one includes four levels,0 represents normal,3 represents mild symptom,6 represents moderate symptom,9 represents Severe symptom.The secondary symptoms include Day cough,Night cough,Dry throat thirst,fever,blush,Dry stool,Yellow urine ,Red tongue and pulse.Each one includes different levels.The higher score represents the more meeting The Phlegm-heat Syndrome (Tan-re Zheng) ,the lower score means the opposite.	0,Day 3, Day 7
Secondary	The change value about the volume of sputum after treatment	Monitor the sputum volume everyday and compare changes in sputum volume in the treatment.	0,Day 3, Day 7