Lianhua Qingwen capsule for the treatment of H1N1 Flu: a double blinding, double dummy and muti-central randomized control trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-09000589

Enrollment

Unknown

Registered

2009-10-31

Start date

2009-10-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

H1N1 flu

Interventions

Group A:Lianhua Qingwen capsule 2.4g three times a day + Tamiflu dummy capsules 75mg twice a day taken orally

Group B:Lianhua Qingwen dummy capsule 2.4g three times a day + Tamiflu capsules 75mg twice a day taken orally

Eligibility

Sex/Gender

All

Age

16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with H1N1 flu confirmed by virology (According to the 3rd version of Diagnosis and Treatment Protocol of H1N1 flue, released by Health ministry of People's republic of China, 2009); 2. Patients aged 16 to 65 years old of both gender; 3. Axillary temperature >=37.4 degree C and with at least symptoms including cough, sore throat, headache, myalgia, fatigue, nasal obstruction, running nose, et al.; 4. Disease course was within 36 hours and no other drug for flu was used; 5. Voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe disease, such as cardiovascular, cerabrovasular, hepatic, renal and hematopoietic system disease; 2. Patients with psychiatric disease; 3. Patients with Pharynx - conjunctivitis, Acute obstructive laryngeal - tracheal – bronchitis, Bronchiolitis, pneumonia, Active pulmonary tuberculosis, Bronchiectasis or other pulmonary disease; 4. Allergy to Lianhua qingwen Capsule or other drugs for treatment of H1N1 Flu; 5. Patients under 19 years old use Aspirin for a long time; 6. Patients received H1N1 flue vaccine; 7. Female patients with a positive result in Urine pregnancy test; 8. Extreme obese patients (BMI>=40); 9. Patients participated in other clinical trial within 1 month; 10. Patients with any other reason that was not suitable for this trial judged by clinical doctors.

Design outcomes

Primary

Measure	Time frame
Time to relief of flu-like symptom;	—

Secondary

Measure	Time frame
Virus nucleic acid overcast Time;Time of fever clearance;Time to relief of single flu symtom;Pharmoeconomic outcomes;Hospital stay;Symptoms score of Traditional Chinese Medicine;	—

Countries

China

Contacts

Public ContactZhongping Duan

duan2517@163.com+86 10 63291007

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026