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A multicenter, randomized, double-blind, placebo parallel controlled clinical trial on the efficacy and safety of Lianhua Qingwen granules in the treatment of acute pharyngitis

A multicenter, randomized, double-blind, placebo parallel controlled clinical trial on the efficacy and safety of Lianhua Qingwen granules in the treatment of acute pharyngitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2023000020
Enrollment
Unknown
Registered
2023-07-06
Start date
2023-07-07
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Acute pharyngitis

Interventions

placebo group:Lianhua Qingwen Granule Simulator
test group:Lianhua Qingwen Granules

Sponsors

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Conforming to the diagnosis of acute pharyngitis in Western medicine; 2) Age range from 18 to 65 years old (including boundary values at both ends), regardless of gender; 3) Before enrollment, the researcher evaluated the pharyngeal pain VAS score to be = 4; 4) Patients with a course of disease = 48 hours (defined here as patients who experience symptoms and signs of acute pharyngitis such as sore throat and swollen throat within 48 hours of this visit); 5) Volunteer to participate in clinical trials and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Those with an armpit temperature greater than 38.5 ?; 2) White blood cell count>12 × 109/L; 3) Individuals with diarrhea (loose stools) during enrollment; 4) Patients with bronchitis, pneumonia, suppurative Tonsillitis, or pharyngeal symptoms or inflammation caused by measles, Scarlet fever, influenza, agranulocytosis, infectious Monocyte, leukemia, acute carotid arteritis, etc; 5) Liver function ALT and AST exceed the upper limit of the reference value by 1.5 times, or Scr exceeds the upper limit of the reference value; 6) Patients with serious primary diseases or psychosis such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, Endocrine system; 7) Allergic constitution (those who are allergic to Class 2 or more substances), as well as those who are allergic to known ingredients or any excipients of the study drug (including placebo); 8) Pregnant or planned pregnancies, or those who cannot strictly control contraception during the trial period, lactating women; 9) Suspected or with a history of alcohol or drug abuse; 10) Individuals who have participated in other clinical trials within a month.

Design outcomes

Primary

MeasureTime frame
Median time of disappearance of pharyngeal pain;

Secondary

MeasureTime frame
Change rate of total symptom score from baseline on days 3 and 6;Change rate of pharyngeal pain score from baseline on days 3 and 6;Difference in the disappearance time of pharyngeal pain between two groups;The disappearance rate of pharyngeal pain on the 3rd and 6th days;

Countries

China

Contacts

Public ContactYan Ruan

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

ruanyan63@163.com020-36591361

Outcome results

None listed

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