Efficacy and safety of Qiweiqingyan aerosol in treatment of acute pharyngitis (lung-stomach excess-heat syndrome): a multicenter, randomized, double-blind, placebo-controlled trial

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-15005991
• Date of registration: 2015-02-11
• Prospective Registration: Yes
• Primary sponsor: West China Hospital, Sichuan University
• Public title: Efficacy and safety of Qiweiqingyan aerosol in treatment of acute pharyngitis (lung-stomach excess-heat syndrome): a multicenter, randomized, double-blind, placebo-controlled trial
• Scientific title: Efficacy and safety of Qiweiqingyan aerosol in treatment of acute pharyngitis (lung-stomach excess-heat syndrome): a multicenter, randomized, double-blind, placebo-controlled trial
• Date of first enrolment: 2015-03-16
• Target sample size: 1:140;2:140;3:140;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=10454
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

ChinA

Contacts

• Name: Mao Bing

• Name: Jiang Hongli
• Affiliation: West China Hospital, Sichuan University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Clinical diagnosis of acute pharyngitis;
2. Lung-stomach excess-heat syndrome in traditional Chinese medicine;
3. Within 48 hours of onset;
4. Baseline visual analogue scale score of 5 or more, and sore throat score by traditional Chinese medicine score of 6 or more;
5. Centor criteria <=1;
6. Aged 18 to 65 years old;
7. Patient must voluntarily give written, informed consent and report adverse events and concomitant medication for duration of study.
Exclusion criteria: 1. Temprature greater than 38.5 Centigrade;
2. Use of any medication taken for relief of symptoms including sore throat prior to study initiation;
3. Current use of analgesic or anti-inflammatory regimen requiring treatment with analgesics, NSAIDs or steroids;
4. Chronic pharyngitis;
5. Patients with any suspected or known heart diseases;
6. Patient with severe primary disease of pulmonary, hepatic, renal, or hematological system, or other serious diseases affected the survival, such as cancer or AIDS;
7. Abnormality of myocardial markers test, echocardiogram abnormality, ALT or AST >1.5 times of normal upper limit, abnormality of serum creatine, white blood cell count <3*10^9/L or >10*10^9/L, neutrophil granulocyte >80%;
8. Pregnancy or lactating women, or women who have birth plan;
9. Allergic constitution or known to be allergic to any component in Qiweiqingyan Aerosol;
10. Mental patients or legal disability;
11. Patients having participated or participating in the other trials in last 3 months;
12. To be considered unsuitable for inclusion.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

acute pharyngitis

Intervention(s)

1:Qiweiqingyan aerosol with new propellan;2:Qiweiqingyan aerosol with old propellant ;3:Placebo aerosol with old propellant ;

Primary Outcome(s)

Time to complete resolution of sore throat;Relief rate of sore throat;

Secondary Outcome(s)

Resolution rate of sore throat;Time to relief of sore throat;Intensity of sore throat assessed by VAS;Change of TCM symptoms score;Change of clinical signs score;

Source(s) of Monetary Support

Shandong bencao Pharmaceutical Co., Ltd