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To evaluate the efficacy and safety of Bailui Granule in the treatment of acute pharyngitis (wind-heat syndrome).

To evaluate the efficacy and safety of Bailui Granule in the treatment of acute pharyngitis (wind-heat syndrome).

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006635
Enrollment
Unknown
Registered
2022-09-20
Start date
2022-09-20
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

acute pharyngitis

Interventions

Positive medicine group:Bairui Granule simulant + Reyanning granule, 1 bag each time, 3 times a day, rinse with boiling water
experimental group:Bairui Granule + Reyanning granule simulant, 1 bag each time, 3 times a day, rinse with boiling water

Sponsors

Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) In accordance with the Western medicine diagnosis of acute pharyngitis; (2) TCM syndrome differentiation is wind-heat syndrome; (3) The duration of the disease is less than 48 hours (here defined as the time between the patient's appearance of acute pharyngitis symptoms such as sore throat and pharyngeal redness and swelling is less than 48 hours); (4) armpit temperature =38.5?; (5) VAS score of sore throat =4; (6) Age 18-65 (including 18 and 65), both genders; (7) Voluntarily participate in the clinical trial, give informed consent and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) chronic pharyngitis; (2) Pharyngeal symptoms or inflammation caused by pneumonia, COVID-19, bronchitis, suppurative tonsillitis, or measles, scarlet fever, influenza, granulocytosis, infectious mononucleosis, leukemia, acute carotid arteritis; (3) white blood cell count >11.0×109/L or neutrophil percentage > 80%; (4) had used any Chinese or western drugs for acute pharyngitis, including drugs for relieving sore throat (such as traditional Chinese medicine preparations, glucocorticoids, non-steroidal anti-inflammatory drugs, etc.); (5) Liver function ALT and AST exceeded the upper limit of the normal reference value 1.5 times or Scr exceeded the upper limit of the normal reference value; (6) Complicated with serious diseases of major organs or systems such as heart, brain, liver, kidney, respiratory system and blood system, such as acute myocardial infarction, acute cerebral infarction, viral hepatitis and hemophilia; (7) Allergic constitution, if there is a history of allergy to two or more drugs or food, or allergic to test drugs (including positive drugs and emergency drugs) or their ingredients and excipients; (8) women who are pregnant or planning to become pregnant, breastfeeding women, patients of reproductive age who are unable or unwilling to use adequate contraception during the trial period, or their spouses who are unwilling to use contraception; (9) Suspected or had a history of alcohol dependence or drug abuse; (10) having an intellectual or mental handicap; (11) Participated in or is participating in clinical trials of other drugs or medical devices within one month; (12) According to the judgment of the investigator, there are other lesions or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the work environment and unstable living environment, which are likely to cause loss of follow-up.

Design outcomes

Primary

MeasureTime frame
Disappearance rate of sore throat after 5 days of treatment;

Secondary

MeasureTime frame
Time of disappearance of sore throat;Curative effect of TCM syndrome;Disappearance rate of pharyngeal pain after 3 days of treatment;Changes in VAS score for sore throat from baseline;

Countries

China

Contacts

Public ContactYan Zhanfeng
15210682430@163.com010-84013163

Outcome results

None listed

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