Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | OTHER |
| Beijing Chao Yang Hospital | OTHER |
| Wangjing Hospital, China Academy of Chinese Medical Sciences | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group 1 | Experimental | Reyanning mixture+amoxil capsule simulator |
|
| treatment group 2 | Experimental | Reyanning mixture +amoxil capsule |
|
| control group | Active Comparator | Reyanning mixture simulator +amoxil capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reyanning mixture | Drug | Reyanning mixture , 20ml by mouth , 3 times per day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| antibiotic duration | The duration of antibiotic will be observed. | after 7 days of medication |
| antibiotic dosage | The dosage of antibiotic will be observed. | after 7 days of medication |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| the vanish rate of single symptom/physical sign |
| Measure | Description | Time Frame |
|---|---|---|
| To observe if Reyanning mixture causes liver function damage. | to assess the liver function indicators | after 7 days of medication |
| To observer if Reyanning mixture impacts renal function | to assess the renal function indicators ,including serum creatinine(Cr) and glomerular filtration rate( eGFR) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanming Xie, BA | Contact | 86-13911112416 | ktzu2018@163.com | |
| Lianxin Wang, Doctor | Contact | 86-13521781839 | wlxing@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanming Xie, BA | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
Not provided
Not provided
| Beijing First Hospital of integrated Chinese and Western Medicine | OTHER |
Not provided
Not provided
Not provided
Not provided
| amoxil capsule | Drug | amoxil capsule , 0.5g by mouth , 3 times per day for 7 days |
|
|
| Reyanning mixture simulator | Drug | Reyanning mixture simulator , 20ml by mouth , 3 times per day for 7 days |
|
|
| amoxil capsule simulator | Drug | amoxil capsule simulator , 0.5g by mouth , 3 times per day for 7 days |
|
|
The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever.
| after 7 days of medication |
| 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 |
| 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 |
| after 7 days of medication |
| To observer if Reyanning mixture causes renal damage | to assess the urinalysis indicators | after 7 days of medication |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |