We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pragmatic Randomized Controlled Trial of Chinese Herbal Medicine for Severe Pandemic H1N1 Influenza (200907001-2A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01053533
Recruitment Status : Unknown
Verified January 2010 by Beijing Ditan Hospital.
Recruitment status was:  Recruiting
First Posted : January 21, 2010
Last Update Posted : June 8, 2010
Sponsor:
Collaborators:
Beijing University of Chinese Medicine
State Administration of Traditional Chinese Medicine of the People's Republic of China
China Academy of Chinese Medical Sciences
Information provided by:
Beijing Ditan Hospital

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

Condition or disease Intervention/treatment
Influenza A Virus, H1N1 Subtype Drug: Chinese herbal medicines plus western therapy Drug: western therapy

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2010
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Chinese herbal medicines plus western therapy Drug: Chinese herbal medicines plus western therapy
injections of Chinese herbal medicines and Chinese herbal medicines decoction& supportive therapy and antivirus therapy when necessary
Active Comparator: western therapy
including supportive therapy and antivirus therapy when necessary
Drug: western therapy
supportive therapy and antivirus therapy when necessary



Primary Outcome Measures :
  1. incidence of complication [ Time Frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients. ]
  2. mortality of pandemic H1N1 influenza and all-cause mortality(only for severe pandemic H1N1 influenza patients) [ Time Frame: 28 days ]
  3. proportion of deteriorating into severe H1N1 influenza (only for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza) [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. time to allaying a fever [ Time Frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients ]
  2. time to symptom relief [ Time Frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients ]
  3. time and proportion of H1N1 virus turning to negative [ Time Frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients ]
  4. direct medical cost [ Time Frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients ]
  5. safety outcome(adverse effects) [ Time Frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients ]
  6. days in hospital [ Time Frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients ]
  7. dose and usage of hormones(only for severe pandemic H1N1 influenza patients) [ Time Frame: 28 days ]
  8. Inflammation of lung tissue(only for severe pandemic H1N1 influenza patients) [ Time Frame: 28 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053533


Locations
China, Beijing
Mao Yu Recruiting
Beijing, Beijing, China, 100015
Contact: Yu Mao       myqmz58@yahoo.com   
Contact: Guang Yu Wang       influenzatcm@163.com   
Principal Investigator: Guang YU Wang         
Sponsors and Collaborators
Beijing Ditan Hospital
Beijing University of Chinese Medicine
State Administration of Traditional Chinese Medicine of the People's Republic of China
China Academy of Chinese Medical Sciences

Responsible Party: Beijing Di Tan Hospital
ClinicalTrials.gov Identifier: NCT01053533     History of Changes
Other Study ID Numbers: 20100118
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: June 8, 2010
Last Verified: January 2010

Keywords provided by Beijing Ditan Hospital:
Chinese herbal medicines
pandemic H1N1 influenza
effectiveness
safety

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases