Registration of the Study of Reyanning Mixture
Avainsanat
Abstrakti
Kuvaus
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.
Päivämäärät
| Viimeksi vahvistettu: | 09/30/2018 |
| Ensimmäinen lähetys: | 10/06/2018 |
| Arvioitu ilmoittautuminen lähetetty: | 10/09/2018 |
| Ensimmäinen lähetetty: | 10/11/2018 |
| Viimeisin päivitys lähetetty: | 10/09/2018 |
| Viimeisin päivitys lähetetty: | 10/11/2018 |
| Todellinen opintojen alkamispäivä: | 10/21/2018 |
| Arvioitu ensisijainen valmistumispäivä: | 06/29/2019 |
| Arvioitu tutkimuksen valmistumispäivä: | 12/30/2019 |
Ehto tai tauti
Interventio / hoito
Drug: Reyanning mixture
Drug: amoxil capsule
Drug: control group
Drug: treatment group 1
Vaihe
Varren ryhmät
| Varsi | Interventio / hoito |
|---|---|
| Experimental: treatment group 1 Reyanning mixture+amoxil capsule simulator | Drug: treatment group 1 amoxil capsule simulator , 0.5g by mouth , 3 times per day for 7 days |
| Experimental: treatment group 2 Reyanning mixture +amoxil capsule | |
| Active Comparator: control group Reyanning mixture simulator +amoxil capsule | Drug: control group Reyanning mixture simulator , 20ml by mouth , 3 times per day for 7 days |
Kelpoisuusehdot
| Tutkimukseen soveltuvat iät | 18 Years Vastaanottaja 18 Years |
| Sukupuolet, jotka ovat kelpoisia tutkimukseen | All |
| Hyväksyy terveelliset vapaaehtoiset | Joo |
| Kriteeri | 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. |
Tulokset
Ensisijaiset tulosmittaukset
1. recovery time [after 3 days of medication]
2. recovery time [after 7 days of medication]
3. recovery rate [after 3 days of medication]
4. recovery rate [after 7 days of medication]
5. antibiotic duration [after 7 days of medication]
6. antibiotic dosage [after 7 days of medication]
Toissijaiset tulosmittaukset
1. the vanish rate of single symptom/physical sign [after 3 days of medication]
2. the vanish rate of single symptom/physical sign [after 7 days of medication]
3. the ratio of WBC recovery [after 7 days of medication]
4. the time of fever relieving [after 7 days of medication]
Muut lopputulokset
1. To observe if Reyanning mixture causes liver function damage. [after 7 days of medication]
2. To observer if Reyanning mixture impacts renal function [after 7 days of medication]
3. To observer if Reyanning mixture causes renal damage [after 7 days of medication]
