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Effectiveness and safety of Ojeok-san plus Saengmaek-san for chronic cough

Effectiveness and safety of Ojeok-san plus Saengmaek-san for chronic cough - a randomized, double-blind, placebo-controlled, parallel, single center and investigator-initiated clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003115
Enrollment
30
Registered
2018-08-24
Start date
2018-09-01
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 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

Sponsors

Kyung Hee University Oriental Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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,

Exclusion criteria

Exclusion criteria: 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 ß2 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

Design outcomes

Primary

MeasureTime frame
Cough symptom score measured with cough diary;Cough questionnaire evaluation;Cough visual analogue scale (VAS)

Secondary

MeasureTime frame
Hull Airway Reflux;Gastrointestinal Symptom Rating Scale(GSRS);Chronic coughing questionnaire;gastroesophageal reflux disease questionnaire

Countries

Korea, Republic of

Contacts

Public ContactSuhyun Ji

Kyung Hee University Oriental Medical Center

jshcmc@naver.com+82-2-958-9103

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Mar 1, 2026