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The effectiveness and safety of Luohuazizhu Granule in the treatment of acute tonsillitis, acute non variceal upper gastrointestinal bleeding, urinary system infection with bleeding: a multicenter, randomized, double-blind, double simulation, positive drug parallel control, superiority, basket design, post marketing clinical trial

The effectiveness and safety of Luohuazizhu Granule in the treatment of acute tonsillitis, acute non variceal upper gastrointestinal bleeding, urinary system infection with bleeding: a multicenter, randomized, double-blind, double simulation, positive drug parallel control, superiority, basket design, post marketing clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072261
Enrollment
Unknown
Registered
2023-06-08
Start date
2023-06-08
Completion date
Unknown
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute tonsillitis,Acute nonvariceal upper gastrointestinal bleeding,Urinary system infection with bleeding

Interventions

Test Group:Luohuazizhu Granule + Yiqing Granule Simulator
Control Group:Luohuazizhu Granule Simulator + Yiqing Granule
Test Group:Luohuazizhu Granule,Yinhua Miyanling Tablet Simulator
Control Group:Luohuazizhu Granule Simulator + Yinhua Miyanling Tablet

Sponsors

The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Acute tonsillitis (1) 18 years old = age = 65 years old, regardless of gender; (2) According to the "Clinical Practice Guidelines for the Treatment of Acute Tonsillitis with Traditional Chinese Medicine Monotherapy/Combination of Antibiotics" (2017), patients diagnosed with the syndrome of excessive lung and stomach heat in traditional Chinese medicine with acute breast moth; (3) According to "Otolaryngology Head and Neck Surgery" (9th edition), patients diagnosed with acute tonsillitis in Western medicine; (4) The duration from onset to visit is within 72 hours; (5) Volunteer to participate in this clinical trial and sign an informed consent form. 2. Acute non variceal upper gastrointestinal bleeding (1) 18 years old = age = 65 years old, regardless of gender; (2) According to the Consensus on the Diagnosis and Treatment of Acute Non varicose Upper Gastrointestinal Hemorrhage by Integrated Traditional Chinese and Western Medicine (2019), patients diagnosed with the syndrome of excessive blood loss and stomach heat in traditional Chinese medicine; (3) According to the "Guidelines for the Diagnosis and Treatment of Acute Non variceal Upper Gastrointestinal Bleeding (Hangzhou)" (2018), patients diagnosed with acute non variceal upper gastrointestinal bleeding in Western medicine; (4) Patients with Forrest grade IIc~III or acute gastric mucosa lesions and positive stool occult blood by endoscopy; (5) Volunteer to participate in this clinical trial and sign an informed consent form. 3. Urinary system infection with bleeding (1) 18 years old = age = 65 years old, regardless of gender; (2) According to the "Guidelines for the Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine Internal Medicine - Traditional Chinese Medicine Syndrome Part" (2008), patients diagnosed with traditional Chinese medicine gonorrhea syndrome and heat gonorrhea syndrome; (3) According to Internal Medicine (9th edition), patients diagnosed with Western medicine urinary tract infection with bleeding symptoms; (4) The duration from onset to visit is within 14 days; (5) Volunteer to participate in this clinical trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Acute tonsillitis (1) Known to have a history of allergy to the test drug and any of its ingredients, allergic disease or allergic constitution; (2) Have used other drugs (including hemostatic and stasis removing drugs, analgesic and anti-inflammatory drugs, etc.) to treat the disease after the onset; (3) After examination, it was confirmed to be pharyngeal diphtheria, angina, scarlet fever, infectious mononucleosis, measles, influenza, agranulocytosis, leukemia, Epstein Barr virus infection, neocoronavirus infection, etc; (4) Complicated with pneumonia, bronchitis, severe laryngitis, epiglottitis and other respiratory diseases; (5) Patients with abnormal liver and kidney function (AST and / or ALT elevation = 1.5 times the upper limit of normal reference value, SCR > the upper limit of normal reference value); (6) Patients with a history of infection that has not yet been cured or currently suffering from infectious diseases; (7) There is currently known evidence of drug abuse or a history of drug abuse in the past 1 year; (8) Those with a history of alcohol dependence; (9) Pregnant or lactating women, or patients (and their partners) who have a birth plan during the trial, or who refuse to use effective contraceptives (including intrauterine devices, oral contraceptives and obstructive measures) during the trial; (10) There are any comorbidities that the investigator believes may interfere with the evaluation of the study, including mental diseases, immune diseases, endocrine diseases, malignant tumors, pancreatic diseases, active tuberculosis and other diseases, or the investigator believes that participating in the study may cause patients to face greater risks; (11) Those who participated in other clinical trials within 3 months before enrollment; (12) The investigator judged that the compliance was poor, unwilling or unable to comply with the drug treatment and follow-up decided by the investigator; (13) According to the judgment of the investigator, patients with other factors should not participate in this trial. 2. Acute nonvariceal upper gastrointestinal bleeding (1) Known to have a history of allergy to the test drug and any of its ingredients, allergic disease or allergic constitution; (2) Endoscopically confirmed upper gastrointestinal bleeding caused by esophageal varices or portal hypertensive gastroenteropathy or with malignant tumor; (3) Patients with previous history of chronic liver disease, cirrhosis or variceal bleeding, physical examination revealed ascites, hypersplenism, and laboratory tests suggested abnormal coagulation and liver function and other variceal upper gastrointestinal bleeding; (4) Patients with obvious ulcerative bleeding or hematemesis symptoms revealed by endoscopy; (5) Severe bleeding requiring surgical treatment or bleeding with shock signs (systolic blood pressure the upper limit of normal reference value); (10) Patients with a history of infection that has no

Design outcomes

Primary

MeasureTime frame
Improvement of Pharyngeal pain VAS score compared to baseline ;Negative conversion rate of fecal occult blood afer 7 days;Urinary red blood cell microscopy negative conversion rate afer 7 days;

Secondary

MeasureTime frame
Scoring of Traditional Chinese Medicine Syndrome Efficacy afer 7 days compared to baseline ;Single score of traditional Chinese medicine syndrome symptoms afer 7 days compared to baseline ;Improvement of Pharyngeal pain VAS score compared to baseline ;Urinary red blood cell microscopy negative conversion rate afer 7 days;

Countries

China

Contacts

Public ContactYang Shanjun, Huang Kejiang, Zhang Yu

The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

ysj119@126.com+86 186 4602 6865

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026