Efficacy and Safety of Jinhua Qinggan Granules (JHQG) for the Use of Acute Upper Respiratory Infection ((JHQG-AURI))

Multi-center, Randomized, Double Blind and Placebo Controlled Clinical Trial on the Efficacy and Safety of Jinhua Qinggan (JHQG) Granules for the Treatment of Acute Upper Respiratory Infection (Wind-Heat Pattern)

The goal of this clinical trial is to learn if drug Jinhua Qinggan Granules (JHQG) works to treat acute upper respiratory tract infection in adults. It will also learn about the safety of drug JHQG. The main questions it aims to answer is:

• Following three days of treatment, the overall grade of fever, sore throat, nasal congestion, rhinorrhea, headache, sneezing, cough, and malaise dropped to zero for a whole day.

Researchers will compare drug JHQG to a placebo (a look-alike substance that contains no drug) to see if drug JHQG works to treat acute upper respiratory tract infection.

Participants will:

• Take drug JHQG or a placebo 3 times daily for 3 days
• All subjects are followed up before the trial, and on the same day or day after completing 3 days of medication.

Study Overview

• Status: Completed
• Conditions: Acute Tonsillitis; Acute Pharyngitis; Acute Sinusitis; Acute Rhinitis
• Intervention / Treatment: Drug: Jinhua Qinggan Granules; Drug: Placebo

Detailed Description

JHQG is a Chinese patent medicine that is extensively used for the treatment of H1N1. This prescription has demonstrated significant curative effects in combating H1N1 influenza A. JHQG is listed in the COVID-19 Diagnosis and Treatment Guidelines (5th-10thEdition) jointly issued by the National Health Commission and State Administration of Traditional Chinese Medicine.

JHQG is created from the two classical traditional Chinese medicine (TCM) formulae Ma Xing Shi Gan Decoction and Yin Qiao San Decoction, which have a long history of clinical application within the treatment of influenza. According to past reports, JHQG has a great clinical impact on influenza with the symptoms of high fever, headache, aversion to cold, pharyngalgia, sneezing, cough, muscle ache, etc. According to modern pharmacological studies, JHQG also has the anti-inflammatory, antiviral and antibacterial activities.

The objective of this clinical trial is to evaluate the efficacy and safety of Jinhua Qinggan Granules (JHQG) in treating Acute Upper Respiratory Tract Infection (AURI).

Possible potential benefits include soothing wind and dispersing the lung, clearing heat and detoxification, relieving fever, headache, body aches, sore throat and other related symptoms caused by wind-heat invading the lung.

The subjects in accordance with enrollment and non-exclusion criterion will be assigned to Treatment group and Placebo control group according to the ratio of 2:1 using blocked randomization, stratified by country, in which the Placebo control group shall receive JHQG Granules simulation (placebo) agent, while the treatment group will take Jinhua Qinggan Granules.

• Study Type: Interventional
• Enrollment (Actual): 273
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Karachi
    • Karachi, Karachi, Pakistan, 75270
      • Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosed with AURI;
2. Wind-heat of TCM pattern differentiation;
3. 18 ≤Age ≤ 65;
4. At screening, axillary temperature ≥37.3 ºC and ≤39.0 ºC;
5. At randomization and group assignment, disease course within 48 hours;
6. The subject has signed the informed consent form.

Exclusion Criteria:

1. Patients with influenza, COVID-19, suppurative otitis media, suppurative tonsillitis, acute attack of asthma and chronic obstructive pulmonary disease, pulmonary tuberculosis, primary ciliary dyskinesia syndrome, pleural effusion, interstitial lesions, acute and chronic tracheobronchitis, lower respiratory infections such as pneumonia;
2. WBC > 11.0×109 or NEU% > 80% or with symptoms of thick sputum and suspected bacterial infection;
3. ALT, AST > 2 ULN or CRE>ULN;
4. Nasal surgery, nasopharyngeal radiotherapy, acute and chronic nasal diseases or abnormal nasal mucosal function (e.g. rhinitis, sinusitis);
5. Patients with diseases diagnosed by specific pathogens (e.g. mumps, measles, hemorrhagic fever, typhoid, chicken pox, allergic rhinitis);
6. Fever caused by other clearly diagnosed organic diseases outside the respiratory system;
7. Accompanied by cardiovascular diseases (e.g. coronary heart disease, myocarditis, etc., excluding hypertension with stable blood pressure control and asymptomatic old lacunar infarction), major kidney, liver, hematological diseases, major nervous and neuromuscular diseases, major metabolic and endocrine diseases and immunosuppression (including immunosuppressant or HIV infection, etc.), and malignant tumor;
8. Subjects, who were treated with antivirals, antibiotics, western or traditional medicines for alleviating symptoms of upper respiratory infection within 12 hours before enrollment;
9. Allergic individuals and those who are known to be allergic to investigational drugs, including the ingredients of this product, acetaminophen or drug excipients;
10. Women who are pregnant or plan to become pregnant within the next 1 months, lactating women; from signature of informed consent form, until 30 days after the last study medication, patients of childbearing age who are unable or unwilling to use adequate contraception or their spouses are unwilling to use contraception;
11. Suspected or do have a history of alcohol or drug abuse;
12. Participated in other clinical trials or are participating in other clinical trials in the past 3 months;
13. Subjects not suitable for enrollment based on investigators' judgment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jinhua Qinggan Granules; Participants receive Jinhua Qinggan Granules according to the study protocol.	Drug: Jinhua Qinggan Granules; Jinhua Qinggan Granules administered orally according to the study protocol.
Placebo Comparator: Placebo; Participants receive placebo matched in appearance to JHQG.	Drug: Placebo; Placebo granules matched in appearance and administration to Jinhua Qinggan Granules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically Curative Rate after 3 days of medication	Proportion of participants whose Total Symptom Severity Score decreases to 0 and remains 0 for at least 24 consecutive hours after 3 days of medication. The Total Symptom Severity Score is calculated by summing the severity of: Fever, Headache, Sore throat, Nasal congestion, Rhinorrhea, Sneezing, Cough, Malaise Each symptom is graded on a 4-point scale: 0 = none; = mild; = moderate; = severe Total score range: 0 to 24. Higher scores indicate more severe symptoms (worse condition).	After 3 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Curative effect	Number of participants classified as clinically cured, remarkably effective, effective, or ineffective according to the predefined curative index criteria specified in the study protocol. Unit of Measure: Number of participants	After 3 days of medication
Change from Baseline in Total Symptom Severity Score	Change from baseline to after 3 days of medication in the Total Symptom Severity Score (range: 0-24), calculated as the sum of the severity scores for the predefined symptoms. Higher scores indicate greater symptom severity. Unit of Measure: Points	Baseline to after 3 days of medication
Time to Defervescence	Time from the first dose of study medication to normalization of body temperature (<37.3°C) that is maintained continuously for at least 24 consecutive hours without recurrence of fever. Unit of Measure: Hours	From first dose up to Day 3
Time to Recovery of Individual	Time from the first dose of study medication to complete resolution (symptom severity score = 0) of each predefined symptom. Results will be reported separately for each symptom (e.g., sore throat, cough, nasal congestion, rhinorrhea, headache, sneezing, malaise). Unit of Measure: Hours	From first dose up to Day 3
Improvement in Individual Symptoms	Improvement in Individual Symptoms (decrease from baseline in symptom severity score) for each predefined symptom among participants who had that symptom at baseline. Symptom severity is assessed using the 0-3 symptom severity scale. Results will be reported separately for each symptom. Unit of Measure: Percentage of participants (%)	Baseline to after 3 days of medication
Proportion of Participants Using Acetaminophen	Percentage of participants who received acetaminophen as rescue medication for fever during the treatment period. Unit of Measure: Percentage of participants (%)	After 3 days of medication

Collaborators and Investigators

• Sponsor: University of Karachi

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2026
• Primary Completion (Actual): April 24, 2026
• Study Completion (Actual): April 27, 2026

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold; jinhua qinggan granules
• Other Study ID Numbers: CRO-010-TCM-JHQG-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No