Qinqiao Yan Shu Granules for the Treatment of Acute Pharyngitis (Exterior Wind-Heat Syndrome) Phase II Clinical Trial

NCT06932328 | Recruiting Phase 2

• 1 other identifier: JM-2024-04
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 7

Brief Summary

Trial Objectives and Exploration Indicators：

1. 1.To explore the improvement effect of different doses of Qinqiao Yanshu Granules on the symptoms/conditions and TCM syndromes of acute pharyngitis (Wind - Heat Exogenous Syndrome), and its effect on shortening the course of the disease.
2. 2.To observe the safety of the clinical application of Qinqiao Yanshu Granules. Overall Trial Design：A block - randomized, double - blind, dose - escalation, multicenter clinical trial design was adopted.
3. 3.High - dose group: Specification: 12g/bag;
4. 4.Low - dose group: Specification: 12g/bag.
5. 5.The criterion for the disappearance of pharyngeal pain: The pharyngeal pain VAS score drops to 0 points and persists for 24 hours or more.
6. 6.Pharyngeal pain VAS score:
7. 7.The criterion for the effective rate of pharyngeal signs: "Effective" is defined as a decrease of at least 1 point in the pharyngeal sign score. The effective rate = (Number of effective cases / Total number of cases) × 100%.
8. 8.The criterion for the clinical cure of the disease: The clinical symptoms of the disease disappear, and the pharyngeal signs are reduced to mild or less. The cure rate = (Number of cured cases / Total number of cases) × 100%.
9. 9.The definition of the efficacy of TCM syndromes:
10. 10.Meeting the Western medical diagnostic criteria for acute pharyngitis;
11. 11.Meeting the TCM syndrome differentiation criteria for Wind - Heat Exogenous Syndrome;
12. 12.The course of the disease at the time of consultation ≤ 48 hours;
13. 13.The pharyngeal pain VAS score ≥ 4 points and the pharyngeal sign score ≥ 1 point;
14. 14.Aged between 18 and 65 years old (including the boundary values), regardless of gender;
15. 15.Voluntarily participating in this clinical trial and signing the informed consent form.
16. 16.Those with pharyngeal symptoms or inflammation caused by measles, scarlet fever, agranulocytosis, infectious mononucleosis, influenza, diphtheria, acute epiglottitis, acute carotid arteritis, etc.;
17. 17.Those with concurrent acute sinusitis, acute laryngitis, suppurative tonsillitis, bronchitis, pneumonia;
18. 18.Those with a modified Centor score ≥ 2, a body temperature peak \> 38.5°C (axillary temperature) within 24 hours before this visit, a white blood cell count \> 1.2 × ULN, a neutrophil percentage \> 1.2 × ULN, and considered to be bacterial infections by the researcher;
19. 19.Those with concurrent severe primary diseases of the cardiovascular and cerebrovascular system, liver, kidney, hematopoietic system, endocrine system, and mental diseases;
20. 20.Those with a history of thyroid - related diseases such as hyperthyroidism and hypothyroidism;
21. 21.Those with laboratory test results

Conditions

Acute Pharyngitis

Outcome Measures

Primary Outcomes (1)

• The disappearance rate of pharyngeal pain 3 and 5 days after treatment

  3days/5days

Study Arms (3)

Qinqiao Yanshu Granules High - dose group

EXPERIMENTAL

Drug: Qinqiao Yanshu Granules

Qinqiao Yanshu Granules Low - dose group

EXPERIMENTAL

Drug: Qinqiao Yanshu Granules

Qinqiao Yanshu Granules Extremely low - dose group

EXPERIMENTAL

Drug: Qinqiao Yanshu Granules

Interventions

Qinqiao Yanshu Granules DRUG

High - dose group: Dissolve in boiling water and take 1 bag each time, 3 times a day, half an hour before meals; Low - dose group: Dissolve in boiling water and take 1 bag each time, 3 times a day, half an hour before meals; Extremely low - dose group: Dissolve in boiling water and take 1 bag each time, 3 times a day, half an hour before meals; Rescue medication: Paracetamol tablets. During the trial, if the subject's body temperature exceeds 38.5°C (including 38.5°C), rescue medication can be added. Use it according to the instructions and doctor's advice and record it truthfully.

Qinqiao Yanshu Granules Extremely low - dose group; Qinqiao Yanshu Granules High - dose group; Qinqiao Yanshu Granules Low - dose group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the Western medicine diagnostic criteria for acute pharyngitis.
• Meeting the TCM syndrome differentiation criteria for the syndrome of wind-heat invading the exterior.
• The disease course at the time of visit is ≤ 48 hours.
• The VAS score for pharyngeal pain is ≥ 4 points, and the pharyngeal sign score is ≥ 1 point.
• Age between 18 and 65 years old (including the boundary values), regardless of gender.
• Voluntarily participating in this clinical trial and signing the informed consent form.

You may not qualify if:

• Those with pharyngeal symptoms or inflammation caused by measles, scarlet fever, agranulocytosis, infectious mononucleosis, influenza, diphtheria, acute epiglottitis, acute carotid arteritis, etc.
• Those with concurrent acute sinusitis, acute laryngitis, suppurative tonsillitis, bronchitis, pneumonia.
• Those with a modified Centor score ≥ 2 points, a peak body temperature \> 38.5°C (axillary temperature) within 24 hours before this visit, a white blood cell count \> 1.2 × ULN, a neutrophil percentage \> 1.2 × ULN, and suspected bacterial infection considered by the researcher.
• Those with concurrent severe primary diseases of the cardiovascular and cerebrovascular system, liver, kidney, hematopoietic system, endocrine system, and mental diseases.
• Those with a history of thyroid-related diseases such as hyperthyroidism or hypothyroidism.
• Those who have used any other drugs for the treatment of acute pharyngitis, including drugs for relieving pharyngeal pain (such as traditional Chinese medicines, glucocorticoids, non-steroidal anti-inflammatory drugs, etc.) within 48 hours before this visit.
• Those who are allergic to the ingredients or excipients of the test drug.
• Pregnant or lactating women.
• Those suspected of or with a confirmed history of alcohol or drug abuse.
• Patients who have participated in or are currently participating in other clinical trials within the past month.
• Patients considered by the researcher to be unsuitable for participating in this clinical trial.

Sponsors & Collaborators

• Jianmin Pharmaceutical Group Co., LTD.: lead

Study Sites (7)

The First Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, 150000, China

RECRUITING

The First Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, 410000, China

RECRUITING

Affiliated Hospital of Changchun University of Chinese Medicine

Changchun, Jilin, 130000, China

RECRUITING

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, 250000, China

RECRUITING

The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

RECRUITING

First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300110, China

RECRUITING

Wenzhou Hospital of Traditional Chinese Medicine

Wenzhou, Zhejiang, 325000, China

RECRUITING

Central Study Contacts

Gang Zhao

CONTACT

86+02784514002; 158200458@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: March 26, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

CN (7)