Observation of Cough Variant Asthma Treated in Combination of Chanqin Granules.

Shanghai University of Traditional Chinese Medicine

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Cough Variant Asthma

Treatments: Drug: Chanqin granules

Study type: Interventional

Funder types: Other

Identifiers

NCT03319043

20164Y0199

Details and patient eligibility

About

This single-center, randomized, double-blind, placebo-controlled trial was undertaken at an outpatient clinic in Shuguang Hospital. Newly diagnosed cough variant asthma adult patients with the T.C.M. pattern of pathogenic-wind are randomly divided into treatment and control group, with 60 patients in each group. Clinical observation of the Respiratory Impedance and Inflammation in Cough Variant Asthma adults reated in Combination of Chanqin Granules.

Full description

This single-center, randomized, double-blind, placebo-controlled trial was undertaken at an outpatient clinic in Shuguang Hospital. Newly diagnosed cough variant asthma adult patients with the T.C.M. pattern of pathogenic-wind are randomly divided into treatment and control group, with 60 patients in each group. All patients enrolled are treated with Budesonide + Formoterol Fumarate dry power (160/4.5ug bid) for inhalation. The treatment group are given additional Chanqin granulate (10g bid) and placebo granulate for controlled group. Investigators hypothesis that Chanqin granules may reduce day & night cough score as well as the respiratory impedance, inflammation statues, and improve T.C.M. syndrome after 8 weeks of treatment.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of cough variant asthma according to Western medicine

2. Diagnosis of cough with pathogenic wind syndrome according to TCM

3. Aged between 18 to 70 years, regardless of gender, race or educational and economic status

4. The cough symptom should last for at least 8 weeks

5. Willingness to participate and to sign the informed consent form

Exclusion criteria

1. Patients with history of smoking (or quite smoking for less than 6 months)
2. Systemic use of corticosteroids in the past 4 weeks
3. Upper or lower respiratory tract infection in the past 4 weeks
4. Incapable of corporation with spirometry and FeNO test
5. Other chronic respiratory disease eg: COPD, pulmonary cirrhosis
6. Women who are pregnant or preparing to become pregnant or breast feeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

treatment group

Experimental group

Description:

patients are treated with Budesonide + Formoterol Fumarate dry powder (160/4.5ug bid) for inhalation and additional Chanqin granules 10g three times a day. All granules will be taken orally with 200 ml warm water.

Treatment:

Drug: Chanqin granules

controlled group

Placebo Comparator group

Description:

patients enrolled in the research are treated with Budesonide + Formoterol Fumarate dry powder (160/4.5ug bid) for inhalation and Chanqin analogous granules. All granules will be taken orally with 200 ml warm water.

Treatment:

Drug: Chanqin granules