A Pragmatic Randomized Controlled Trial of Chinese Herbal Medicine for Severe Pandemic H1N1 Influenza

Influenza A Virus, H1N1 Subtype Clinical Trial

— 200907001-2A  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01053533
• Other study ID #: 20100118
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2010
• Last updated: June 7, 2010
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: January 2010
• Source: Beijing Ditan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China:Beijing Ditan Hospital's IRB
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe pandemic H1N1 influenza.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of severe pandemic H1N1 influenza patients and pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza

• Rapid Diagnostic Tests:positive

• Age=6 years

• Influenza symptoms occurred less than 48 hours and body temperature=37.5? for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza

Exclusion Criteria:

• Suffering from mental illness

• Attending other clinical studies on influenza

• Critical pandemic H1N1 influenza patients

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza A Virus, H1N1 Subtype
• Influenza, Human

Intervention

Drug:
• Chinese herbal medicines plus western therapy
injections of Chinese herbal medicines and Chinese herbal medicines decoction& supportive therapy and antivirus therapy when necessary
• western therapy
supportive therapy and antivirus therapy when necessary

Locations

Country	Name	City	State
China	Mao Yu	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Beijing Ditan Hospital	Beijing University of Chinese Medicine, China Academy of Chinese Medical Sciences, State Administration of Traditional Chinese Medicine of the People's Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of complication		10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients.	No
Primary	mortality of pandemic H1N1 influenza and all-cause mortality(only for severe pandemic H1N1 influenza patients)		28 days	No
Primary	proportion of deteriorating into severe H1N1 influenza (only for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza)		10 days	No
Secondary	time to allaying a fever		10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients	No
Secondary	time to symptom relief		10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients	No
Secondary	time and proportion of H1N1 virus turning to negative		10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients	No
Secondary	direct medical cost		10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients	No
Secondary	safety outcome(adverse effects)		10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients	Yes
Secondary	days in hospital		10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients	No
Secondary	dose and usage of hormones(only for severe pandemic H1N1 influenza patients)		28 days	No
Secondary	Inflammation of lung tissue(only for severe pandemic H1N1 influenza patients)		28 days	No