Acute TonsillitisPhase 4NCT03704506
Registration of the Study of Reyanning Mixture
A Phase 4 study testing Reyanning mixture, amoxil capsule and Reyanning mixture simulator in people with Acute Tonsillitis, run by China Academy of Chinese Medical Sciences.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Tonsillitis
- What is being tested?
- Reyanning mixture, amoxil capsule and Reyanning mixture simulator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 22 Oct 2018to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria of acute tonsillitis;
- Meet the traditional Chinese medicine symptom diagnostic criteria of external wind-heat type and excessive heat in the lung and stomach type;
- 18 years≤age≤65 years;
- course of disease within 72 hours;
- sign informed consent.
Who cannot join
- common cold,influenza, acute laryngopharyngitis, pharyngeal diphtheria, wensang's isthmitis.
- complicated with acute tracheobronchitis,pneumonia,rheumatic fever, acute glomerulonephritis or rheumatic heart disease.
- complicated with severe angiocardiopathy, cerebrovascular disease, hemopoietic system disease or psychopath.
- liver or kidney function is abnormal(ALT>1.5 times upper limit of normal; Cr>upper limit of normal); diabetic.
- WBC<10×109/L and neutrophilic granulocyte percentage<75%;or WBC ≥20×109/L;
- gestational, lactating women or who planning to get pregnant within half a year.
- already accept similar traditional Chinese medicine or antibiotic within 48 hours before registered.
- joining other clinical trials or allergic to any drug in this trials.
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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
- Being tested
- Reyanning mixture, amoxil capsule, Reyanning mixture simulator, amoxil capsule simulator
- Keywords
- Reyanning mixture, efficacy, safety, randomized, double-blind, placebo-controlled, multicenter, antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reyanning mixtureDrug
Also called Reyanning
Reyanning mixture , 20ml by mouth , 3 times per day for 7 days
amoxil capsuleDrug
Also called amoxicillin
amoxil capsule , 0.5g by mouth , 3 times per day for 7 days
Reyanning mixture simulatorDrug
Also called Reyanning simulator
Reyanning mixture simulator , 20ml by mouth , 3 times per day for 7 days
amoxil capsule simulatorDrug
Also called amoxicillin simulator
amoxil capsule simulator , 0.5g by mouth , 3 times per day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| treatment group 1 | Experimental | Reyanning mixture+amoxil capsule simulator Receives: Drug: Reyanning mixture; Drug: amoxil capsule simulator |
| treatment group 2 | Experimental | Reyanning mixture +amoxil capsule Receives: Drug: Reyanning mixture; Drug: amoxil capsule |
| control group | Active comparator | Reyanning mixture simulator +amoxil capsule Receives: Drug: amoxil capsule; Drug: Reyanning mixture simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: after 7 days of medication
antibiotic duration
The duration of antibiotic will be observed.
Measured: after 7 days of medication
antibiotic dosage
The dosage of antibiotic will be observed.
Measured: after 7 days of medication
Secondary outcomes (4)
the vanish rate of single symptom/physical sign
The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever.
Measured: after 3 days of medication
the vanish rate of single symptom/physical sign
The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever.
Measured: 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.
Measured: 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.
Measured: after 7 days of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start22 Oct 2018 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute TonsillitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Beijing Chao Yang Hospital, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing First Hospital of integrated Chinese and Western Medicine
- Responsible party
- Principal investigator, Yanming Xie, China Academy of Chinese Medical Sciences
- Investigators
- Yanming Xie, BA, Principal investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704506
- Sponsor's protocol ID
- Reyanning mixture
- Status last verified
- Oct 2018
- First submitted
- 7 Oct 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03704506
- Acronym / sponsor ID
- Reyanning mixture
- Conditions
- Acute Tonsillitis
- Keywords
- Reyanning mixture, efficacy, safety, randomized, double-blind, placebo-controlled, multicenter, antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Beijing Chao Yang Hospital, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing First Hospital of integrated Chinese and Western Medicine
- Study start
- 22 Oct 2018 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| treatment group 1 | Experimental | Drug: Reyanning mixture, Drug: amoxil capsule simulatorReyanning mixture+amoxil capsule simulator |
| treatment group 2 | Experimental | Drug: Reyanning mixture, Drug: amoxil capsuleReyanning mixture +amoxil capsule |
| control group | Active comparator | Drug: amoxil capsule, Drug: Reyanning mixture simulatorReyanning mixture simulator +amoxil capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet the diagnostic criteria of acute tonsillitis;
- Meet the traditional Chinese medicine symptom diagnostic criteria of external wind-heat type and excessive heat in the lung and stomach type;
- 18 years≤age≤65 years;
- course of disease within 72 hours;
- sign informed consent.
Key exclusion criteria (8 listed)
- common cold,influenza, acute laryngopharyngitis, pharyngeal diphtheria, wensang's isthmitis.
- complicated with acute tracheobronchitis,pneumonia,rheumatic fever, acute glomerulonephritis or rheumatic heart disease.
- complicated with severe angiocardiopathy, cerebrovascular disease, hemopoietic system disease or psychopath.
- liver or kidney function is abnormal(ALT>1.5 times upper limit of normal; Cr>upper limit of normal); diabetic.
- WBC<10×109/L and neutrophilic granulocyte percentage<75%;or WBC ≥20×109/L;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reyanning mixtureAlso: ReyanningReyanning mixture , 20ml by mouth , 3 times per day for 7 days | Drug | treatment group 1, treatment group 2 |
| amoxil capsuleAlso: amoxicillinamoxil capsule , 0.5g by mouth , 3 times per day for 7 days | Drug | control group, treatment group 2 |
| Reyanning mixture simulatorAlso: Reyanning simulatorReyanning mixture simulator , 20ml by mouth , 3 times per day for 7 days | Drug | control group |
| amoxil capsule simulatorAlso: amoxicillin simulatoramoxil capsule simulator , 0.5g by mouth , 3 times per day for 7 days | Drug | treatment group 1 |
Primary outcome
recovery time
Time frame: after 3 days of medication
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.
recovery time
Time frame: after 7 days of medication
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.
recovery rate
Time frame: after 3 days of medication
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.
recovery rate
Time frame: after 7 days of medication
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.
antibiotic duration
Time frame: after 7 days of medication
The duration of antibiotic will be observed.
antibiotic dosage
Time frame: after 7 days of medication
The dosage of antibiotic will be observed.
4 secondary outcomes
the vanish rate of single symptom/physical sign
Time frame: after 3 days of medication
the vanish rate of single symptom/physical sign
Time frame: after 7 days of medication
the ratio of WBC recovery
Time frame: after 7 days of medication
the time of fever relieving
Time frame: after 7 days of medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanming Xie, BA principal investigator
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reyanning mixture, amoxil capsule and Reyanning mixture simulator in people with Acute Tonsillitis, run by China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanming Xie, BA (86-13911112416, ktzu2018@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recovery time (time frame: after 3 days of medication). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.