A randomized, double-blind, placebo-controlled clinical trial of Shen Mi Tang in Treating subacute cough

Phase 3

• Conditions: post infectious cough; Respiratory - Other respiratory disorders / diseases; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12613000905763
• Lead Sponsor: Jong-Jen Kuo (Principal investigator)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1.age from 20 to 65 y/o
2.persist cough for 3-8 weeks without present illness as asthma, Gastroesophageal reflux disease,postnasal drip)
3.Cough pattern is dry cough or cough with little sputum. presentations of cough are throat itching, paroxysmal cough or cough irritated by smoke,dust or temperature.
4.Day time or night-time Cough Symptom Score (CSS) >= 2
5.sign informed consent form

Exclusion Criteria

1.chronic respiratory disease as asthma, bronchiectasis
,chronic bronchitis etc.
2.severe disorders which may induce persistent cough (as:cystic fibrosis,congestive heart failure etc.)
3.Gastroesophageal reflux disease or postnasal drip detected by patient or diagnosed by doctor in recent 3 months
4.neoplasm or other significant abnormality suspected under chest X ray examination
5.recent smoker (smoking abstinence shorter than 6 months )
6.pregnant or breast feeding women
7.taking Angiotension-converting enzyme inhibitors in 1 month
8.body temperature over 37.5 degrees Celsius
9.blood WBC >10000 per microliter or < 4000 per microliter
10.difficult to fit in with study process
11.other clinical trial participants in recent 1 month

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with Significant Improvement in daytime Cough Symptom Score(CSS) will be the primary efficacy endpoint of this study.<br>[Significant Improvement is defined as that patient's CSS score on day 8 is reduced by two or more score levels comparing with the baseline CSS on day 1.<br>]

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with ’’Improvement” in daytime or night-time Cough Symptom Score(CSS)<br>[Improvement” is defined as that patient’s CSS score on day 8 is reduced by one score level comparing with the baseline CSS on day 1.<br>];Change from baseline in visual analogous scale(VAS) score on cough severity[a visual analogous scale of 0 to 100 mm at the time points (Day 1,3,5,8,15).]