A randomized, double-blind, placebo-controlled clinical trial of Shen Mi Tang in Treating subacute cough
In patients with post infectious cough of 3-8 weeks, does Shen Mi Tang compared to placebo, improve cough?
Jong-Jen Kuo (Principal investigator)
32 participants
Aug 16, 2013
Interventional
Conditions
Summary
Cough is one of the most common causes for medical consultation. Post infectious cough is one of main causes of Subacute cough. The effectiveness of Over the counter(OTC) drugs for cough are controversial. OTC drugs leading to sedation and other side effects also. The Shen Mi Tang is commercially available herbal concentrates preparation, the indications for asthma, bronchitis. We found its good effects in the treatment of persistent dry cough post colds. So, it deserves evaluation by clinical trial. The clinical trial will be undertaken at Chang Gung Memorial Hospital, 32 Subacute cough patients will be enrolled, 16 patients in Control group and 16 patients in Treatment group. The study will be a randomized, placebo-controlled, double-blind clinical trial with medication for 7 days followed by observation for 7 days also.The focus of the study is on the evaluation of efficacy of this formula for Subacute cough by Cough Symptom Score(CSS) and Visual Analogous Scale(VAS) and the safety of this formula will also be evaluated.
Eligibility
Inclusion Criteria5
- age from 20 to 65 y/o
- persist cough for 3-8 weeks without present illness as asthma, Gastroesophageal reflux disease,postnasal drip)
- 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.
- Day time or night-time Cough Symptom Score (CSS) >= 2
- sign informed consent form
Exclusion Criteria12
- chronic respiratory disease as asthma, bronchiectasis
- ,chronic bronchitis etc.
- severe disorders which may induce persistent cough (as:cystic fibrosis,congestive heart failure etc.)
- Gastroesophageal reflux disease or postnasal drip detected by patient or diagnosed by doctor in recent 3 months
- neoplasm or other significant abnormality suspected under chest X ray examination
- recent smoker (smoking abstinence shorter than 6 months )
- pregnant or breast feeding women
- taking Angiotension-converting enzyme inhibitors in 1 month
- body temperature over 37.5 degrees Celsius
- blood WBC >10000 per microliter or < 4000 per microliter
- difficult to fit in with study process
- other clinical trial participants in recent 1 month
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Interventions
The study will be a randomized, placebo-controlled, double-blind clinical trial with medication for 7 days followed by observation for 7 days also. There were two groups in the study. The subjects of Treatment group will take Shen Mi Tang (400mg), 5 capsules three times a day(6g per day) per oral for a 7 days course of treatment. Components of Shen Mi Tang Ephedrae Herba 6g Armeniacae Semen 4.8g Magnoliae Cortex 3.6g Auranti Nobilis Pericarpium 3g Glycyrrhizae Radix 2.4g Bupleuri Radix 2.4g Perilla Herba 1.8g These raw herbs were refined to 4g extract and mixed with 2g starch to 6g powder by Sheng Chang Pharmaceutical Co., Ltd. dextromethorphan 15mg/TAB per oral one to three times a day will be given as rescue drug when cough is intolerable To get cough symptom score , a phone call at day 3,5 of treatment was given to the patients by study coordinator. a card was also given to patient to record their daily drug taking and Visual Analogue Scale(VAS) of cough. The Visual Analogue Scale(VAS) will be adopted for measuring the severity of patient reported cough.The patient will be asked to mark the severity of his/her cough condition on a visual analogous scale of 0 to 100 mm at the time points (Day 1,3,5,8,15).
Locations(1)
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ACTRN12613000905763