NCT03704506

Registration of the Study of Reyanning Mixture

A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of the Efficacy and Safety of Treating Acute Tonsillitis With Reyanning Mixture Alone/in Combination With Antibiotics.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of treating with acute tonsillitis using Reyanning mixture alone/in combination with antibiotics, and its function of reducing the use of antibiotics.

Detailed description

In order to evaluate the efficacy,safety and the function of reducing the use of antibiotics of Reyanning mixture (a mixture of Chinese herbal medicine) in treating with acute tonsillitis, a randomized, double-blind, placebo-controlled, multicenter clinical trials will be established. According to the relevant regulations of the China Food and Drug Administration(CFDA), 144 cases need to be registered at least. The aim population is who suffering of acute tonsillitis from October 2018 to December 2019.These cases will be randomly divided into treatment group 1(Reyanning mixture +amoxil capsule simulator),treatment group 2(Reyanning mixture +amoxil capsule) and control group(Reyanning mixture simulator +amoxil capsule).Each group will be treated for 7 days and followed up for 3 times . The main indicators include the recovery time/rate and antibiotic duration/dosage. And the vanish rate of single symptom/physical sign, the ratio of white blood cell count(WBC) recovery, the time of fever will be observed as well.

Conditions

• Acute Tonsillitis

Interventions

Type	Name	Description
DRUG	Reyanning mixture	Reyanning mixture , 20ml by mouth , 3 times per day for 7 days
DRUG	amoxil capsule	amoxil capsule , 0.5g by mouth , 3 times per day for 7 days
DRUG	Reyanning mixture simulator	Reyanning mixture simulator , 20ml by mouth , 3 times per day for 7 days
DRUG	amoxil capsule simulator	amoxil capsule simulator , 0.5g by mouth , 3 times per day for 7 days

Timeline

• Start date: 2018-10-22
• Primary completion: 2019-06-30
• Completion: 2019-12-31
• First posted: 2018-10-12
• Last updated: 2018-10-12