Skip to content

A Randomized Double-Blind Double-Dummy Superiority Active Drug-Controlled Parallel-Design Multicenter Clinical Study on the Efficacy and Safety of Lanqin Oral Liquid in the Treatment of Acute Pharyngitis (Lung-Stomach Excess Heat Syndrome)

A Randomized Double-Blind Double-Dummy Superiority Active Drug-Controlled Parallel-Design Multicenter Clinical Study on the Efficacy and Safety of Lanqin Oral Liquid in the Treatment of Acute Pharyngitis (Lung-Stomach Excess Heat Syndrome)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001315
Enrollment
Unknown
Registered
2025-07-01
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Acute Pharyngitis

Interventions

Experimental group:The administration is as follows: Oral administration of Lanqin Oral Liquid (1 vial each time 3 times a day) and Bairui Granule Simulant (1 bag each time 3 times a day) continuously
Control group:The administration is: Bairui Granules (1 bag each time 3 times a day) + Lanqin Oral Liquid Simulant (1 vial each time 3 times a day).

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1)Aged between 18 and 65 years old (inclusive) regardless of gender; (2)Meeting the diagnostic criteria for Western medicine acute pharyngitis and the syndrome differentiation criteria for lung-stomach excess heat syndrome in traditional Chinese medicine; (3)Disease duration = 48 hours at screening; (4)Pharyngeal pain VAS score = 4 points; (5)The research participants have been informed voluntarily signed the informed consent form and agreed to attend all visits examinations and treatments as required by the trial protocol.

Exclusion criteria

Exclusion criteria: (1)Subjects with body temperature >38.5°C or blood routine examination showing white blood cell count and absolute neutrophil count > upper limit of normal reference value (ULN); (2)Subjects complicated with respiratory diseases such as suppurative tonsillitis pneumonia bronchitis otitis media laryngitis herpetic angina etc.; (3)Subjects with pharyngeal symptoms or inflammation caused by measles influenza pharyngeal diphtheria Vincent angina and certain blood diseases (mononucleotic angina agranulocytic angina leukemic angina scarlet fever) etc.; (4)Subjects with severe primary diseases of the heart cerebrovascular system lungs liver kidneys or hematopoietic system and abnormal liver or kidney function (specifically aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >1.5×ULN serum creatinine (Scr) >ULN); (5)Subjects with malignant tumors; (6)Subjects with a documented history of neurological or psychiatric disorders or those judged by the investigator to be unable to cooperate with treatment or follow medical advice; (7)Subjects who have used other Chinese or Western medications for the treatment of this disease (except for the study's emergency medications) within 48 hours prior to screening or who need to take antibiotics or heat-clearing and detoxifying drugs for other diseases; (8)Pregnant women women intending to become pregnant or lactating women; (9)Subjects with allergies to the study drugs or their components or to the study's emergency medications or their components; (10)Subjects who have participated in other drug clinical trials within the past 3 months or medical device clinical trials within the past 1 month; (11)Subjects with a history of chronic alcoholism or drug abuse poor compliance during the screening period or any factors affecting compliance; (12)Subjects whom the investigator deems unsuitable to participate in this clinical trial for other reasons.

Design outcomes

Primary

MeasureTime frame
The change value of the VAS score for sore throat after 5 days of treatment compared with the baseline;

Secondary

MeasureTime frame
Time to onset and duration of effect of sore throat relief;Therapeutic effects of traditional Chinese medicine on symptoms after 3 days and 5 days of treatment; main symptoms and secondary symptoms' therapeutic effects (total effective rate significant improvement rate);Changes in TCM syndrome scores at 3 days and 5 days of treatment compared to the baseline as well as the change rates;Usage of emergency medication (acetaminophen) for 5 days of treatment (frequency of use proportion of study participants who used it);The total effective rate and cure rate of individual symptoms (dry and burning sensation in the throat fever general body aches thirst and excessive drinking cough thick and sticky phlegm) and the therapeutic effect of pharyngeal signs (pharyngeal mucosa congestion and edema) after 3 days and 5 days of treatment;Time for sore throat to disappear;The recovery rate and total effective rate of sore throat after 3 days and 5 days of treatment;;The change values and rates of the VAS score for sore throat after 3 days of treatment compared to the baseline; the rate of change of the VAS score for sore throat after 5 days of treatment compared to the baseline;The therapeutic effects (total effective rate and marked effective rate) of 3-day and 5-day treatment for diseases;

Countries

china

Contacts

Public Contacthongchun zhang

China-Japan Friendship Hospital

13701226664@139.com13701226664

Outcome results

None listed

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