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

Sponsor

Zhong Wang (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04834531

Collaborator

(none)

324

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Chronic Bronchitis	Drug: Zhuli capsule Drug: Placebo Other: Standard medical treatment	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

324 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zhuli capsule Base 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.	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. 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.
Placebo Comparator: Placebo Base 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.	Drug: 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.

Arm

Intervention/Treatment

Experimental: Zhuli capsule

Base 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.

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.

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.

Placebo Comparator: Placebo

Base 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.

Drug: 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

Outcome Measures

Primary Outcome Measures

The clinical control rate of sputum [Day 7]
Defined as the proportion of patients with the expectoration rate ≥90%.

Secondary Outcome Measures

Time to sputum turn white [up to Day 7]
Cough Symptom Score Scale [0,Day 3, Day 7]
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.
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]
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.
The change value about the volume of sputum after treatment [0,Day 3, Day 7]
Monitor the sputum volume everyday and compare changes in sputum volume in the treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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. -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China-Japan Friendship Hospital	Beijing	Beijing	China	100029
2	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong	China	510120
3	Sichuan Provincial Hospital of Traditional Chinese Medicine	Chengdu	Sichuan	China	610075
4	Zhejiang Provincial Hospital of Chinese Medicine	Hangzhou	Zhejiang	China	310006