Registration of the Study of Reyanning Mixture

Acute Tonsillitis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03704506
• Other study ID #: Reyanning mixture
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 22, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2018
• Source: China Academy of Chinese Medical Sciences
• Contact: Yanming Xie, BA
• Phone: 86-13911112416
• Email: ktzu2018[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Meet the diagnostic criteria of acute tonsillitis;

2. Meet the traditional Chinese medicine symptom diagnostic criteria of external wind-heat type and excessive heat in the lung and stomach type;

3. 18 years=age=65 years;

4. course of disease within 72 hours;

5. sign informed consent.

Exclusion Criteria:

1. common cold,influenza, acute laryngopharyngitis, pharyngeal diphtheria, wensang's isthmitis.

2. complicated with acute tracheobronchitis,pneumonia,rheumatic fever, acute glomerulonephritis or rheumatic heart disease.

3. complicated with severe angiocardiopathy, cerebrovascular disease, hemopoietic system disease or psychopath.

4. liver or kidney function is abnormal(ALT>1.5 times upper limit of normal; Cr>upper limit of normal); diabetic.

5. WBC<10×109/L and neutrophilic granulocyte percentage<75%;or WBC =20×109/L;

6. gestational, lactating women or who planning to get pregnant within half a year.

7. already accept similar traditional Chinese medicine or antibiotic within 48 hours before registered.

8. joining other clinical trials or allergic to any drug in this trials.

Related Conditions & MeSH terms

• Acute Tonsillitis
• Peritonsillar Abscess
• Tonsillitis

Intervention

Drug:
• Reyanning mixture
Reyanning mixture , 20ml by mouth , 3 times per day for 7 days
• amoxil capsule
amoxil capsule , 0.5g by mouth , 3 times per day for 7 days
• Reyanning mixture simulator
Reyanning mixture simulator , 20ml by mouth , 3 times per day for 7 days
• amoxil capsule simulator
amoxil capsule simulator , 0.5g by mouth , 3 times per day for 7 days

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Beijing Chao Yang Hospital, Beijing First Hospital of integrated Chinese and Western Medicine, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Wangjing Hospital, China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To observe if Reyanning mixture causes liver function damage.	to assess the liver function indicators	after 7 days of medication
Other	To observer if Reyanning mixture impacts renal function	to assess the renal function indicators ,including serum creatinine(Cr) and glomerular filtration rate( eGFR)	after 7 days of medication
Other	To observer if Reyanning mixture causes renal damage	to assess the urinalysis indicators	after 7 days of medication
Primary	recovery time	The recovery time will be observed. Recovery means that the main signs and symptoms score is zero, and body temperature is below 37.3 ? maintaining for at least 24 hours.	after 3 days of medication
Primary	recovery time	The recovery time will be observed. Recovery means that the main signs and symptoms score is zero, and body temperature is below 37.3 ? maintaining for at least 24 hours.	after 7 days of medication
Primary	recovery rate	The recovery rate will be observed. Recovery means that the main signs and symptoms score is zero, and body temperature is below 37.3 ? maintaining for at least 24 hours.	after 3 days of medication
Primary	recovery rate	The recovery rate will be observed. Recovery means that the main signs and symptoms score is zero, and body temperature is below 37.3 ? maintaining for at least 24 hours.	after 7 days of medication
Primary	antibiotic duration	The duration of antibiotic will be observed.	after 7 days of medication
Primary	antibiotic dosage	The dosage of antibiotic will be observed.	after 7 days of medication
Secondary	the vanish rate of single symptom/physical sign	The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever.	after 3 days of medication
Secondary	the vanish rate of single symptom/physical sign	The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever.	after 7 days of medication
Secondary	the ratio of WBC recovery	The ratio of WBC recovery refers to the percentage of white blood cell count which return to normal range after 7 days of medication.	after 7 days of medication
Secondary	the time of fever relieving	The time of fever relieving means that the duration from the first medication to the body temperature drops below 37.3? maintaining for at least 24 hours.	after 7 days of medication