The aim of this study was to evaluate the efficacy and safety of miscarriage SA in patients with chronic cough due to gastroesophageal reflux.
Cough is the most common disease outpatient, distinguished by duration, cough within 3 weeks is acute, cough in 3 to 8 weeks is subacute, and cough in 8 weeks or more is chronic cough. Chronic cough for 8 weeks or more is associated with lower quality of life. In severe cases, it causes complications such as nausea, vomiting, chest pain, rib fracture, urinary incontinence, syncope, and depression.
Patients who complain of chronic cough are referred to patients who complain of cough due to gastroesophageal reflux. The patients will be recruited from the Breathing Internal Medicine Department of Kyunghee Medical Center Oriental Medicine Hospital. Clinical trials will be conducted at the Clinical Center for Oriental Medicine in Kyung Hee Medical Center. After screening the participants for the purpose of the clinical trial, screen the participants for the consent form. Participants eligible for the selection / exclusion criteria through screening will be recruited as study subjects, who will then be assigned to the test and control groups and will be prescribed a drug for each group for six weeks. In the test group, 5.76 g once a day and 6 times a day for 6 weeks, and the control group should take 5.76 g of placebo (placebo) once daily for 6 weeks.
Cough symptom score measured with cough diary
Cough questionnaire evaluation, Cough visual analogue scale (VAS),Hull Airway Reflux,Gastrointestinal Symptom Rating Scale(GSRS),Chronic coughing questionnaire,gastroesophageal reflux disease questionnaire evaluation.
A double-sided test will be conducted with the following hypothesis to test the effect of differences between the test group (miscarriage simvastatin) and the control group (placebo).
null Hypothesis: There is no difference in the cough symptom score changes measured by the cough diary after 6 weeks of randomization in the test and control groups.
Alternative Hypothesis: There is a difference in the cough symptom score changes measured by the cough diary after 6 weeks of randomization in the test and control groups.

Treatment

Common name / Product name:Hansin Ojeok-san plus Saengmaek-san 
Usage: 3 times a day, 1 hour after meals
Capacity: Ojeok-san 4.35 g /1 time,Saengmaek-san 1.41 g /1time,  total 5.76g/1time
Route of administration: Oral
period of administration: 6week
placebo: 3 times a day, 1 hour after meals
Ojeok-san placebo 4.35 g /1 time,Saengmaek-san 1.41 g /1time  total 5.76g/1time
Route of administration: Oral
period of administration: 6week

Arm Label

Target Number of Participant

Arm Type

Arm Description

placebo: 3 times a day, 1 hour after meals
Ojeok-san placebo 4.35 g /1 time,Saengmaek-san 1.41 g /1time  total 5.76g/1time
Route of administration: Oral
period of administration: 6week

Arm Label

Target Number of Participant

Arm Type

Arm Description

Common name / Product name:Hansin Ojeok-san plus Saengmaek-san 
Usage: 3 times a day, 1 hour after meals
Capacity: Ojeok-san 4.35 g /1 time,Saengmaek-san 1.41 g /1time,  total 5.76g/1time
Route of administration: Oral
period of administration: 6week

Gender

Age

Description

1) Only 19 years old and under 70 years old
2) Persons who have continued coughing for more than 8 weeks
3) who have been diagnosed with reflux esophagitis within the last 1 year
4) In case of patient,

1) Those with abnormal findings that could cause cough as a result of chest x-ray
2) Those with abnormal findings in lung function tests
3) Those with evidence of coughing on nasal endoscopy
4) Those who have been diagnosed with acute respiratory disease including upper respiratory tract within the last 1 month
5) Those who have been diagnosed with chronic respiratory diseases (chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis, interstitial pulmonary disease and other chronic respiratory diseases) within the last 2 years
6) who have been diagnosed gastroesophageal reflux disease of LA grade C or higher within the last 1 year
7) Patients who present with symptoms that can predict the malignant disease of the gastrointestinal tract (swallowing, severe dysphagia, bleeding, weight loss, anemia, stool, etc.)
8) Patients who had previously undergone surgical or endoscopic anti-reflux treatment
9) Patient with Hubiru syndrome
10) Patients with active infection requiring systemic antibiotic treatment
11) Patients with blood clotting disorder
12) Those who smoke more than 20 packs (400 packs)
13) Those who have been taking or have taken an angiotensin-converting-enzyme inhibitor within the last 4 months
14) Those who have been taking chronotherapy, steroids, anti-leukotrienes, anticholinergics, long-acting β2 agonists, and any herbal medicines within the last 2 weeks
15) Those taking antihistamines within the last 2 weeks
16) Those who have taken proton pump inhibitors, histamine receptor antagonists, mucosal protective agents, gastrointestinal motility promoters, antacids, antidepressants, anxiolytics, and lower esophageal sphincter agonists for the treatment of gastroesophageal reflux disease symptoms within the last 2 weeks
17) Allergy or sensitizer to test drug / placebo
18) Those with a low birth weight below 18.5 on the BMI
19) Blood test results showed that AST and ALT were 2 times higher than the normal upper limit and Creatinine was 1.2 times higher than the normal upper limit
20) Those with a mean cough diary of 2 or less during the run-in-period period (7 days)
21) who recorded less than 10 cough diaries during the run-in-period period (7 days)
22) Those who had malignant tumors such as lung cancer or esophageal cancer within 5 years
23) Excessive drinking
24) Those who are pregnant or lactating
25) Those who did not consent to contraception during the clinical trial
26) Patients who participated in clinical trials for the same disease within the past 3 months
27) Those who are not eligible to take part in this trial at the discretion of the investigator

Cough symptom score measured with cough diary

Baseline , Week 2, Week 4, week 6, week 8  evaluation.

Cough questionnaire evaluation

Baseline , Week 2, Week 4, week 6, week 8  evaluation.

Cough visual analogue scale (VAS)

Baseline , Week 2, Week 4, week 6, week 8  evaluation.

Hull Airway Reflux

Baseline , Week 2, Week 4, week 6, week 8  evaluation.

Gastrointestinal Symptom Rating Scale(GSRS)

Baseline , Week 2, Week 4, week 6, week 8  evaluation.

Chronic coughing questionnaire

Baseline ,  week 6,  evaluation.

gastroesophageal reflux disease questionnaire

Baseline ,  week 6 evaluation.