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

NCT07720583 | Completed Phase 3 DMC

• 1 other identifier: CRO-010-TCM-JHQG-2023
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Pharyngitis; Acute Rhinitis; Acute Tonsillitis; Acute Sinusitis

Outcome Measures

Primary Outcomes (1)

• 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 1. = mild 2. = moderate 3. = severe Total score range: 0 to 24. Higher scores indicate more severe symptoms (worse condition).

  After 3 Days

Secondary Outcomes (6)

• Curative effect

  After 3 days of medication

• Change from Baseline in Total Symptom Severity Score

  Baseline to after 3 days of medication

• Time to Defervescence

  From first dose up to Day 3

• Time to Recovery of Individual

  From first dose up to Day 3

• Improvement in Individual Symptoms

  Baseline to after 3 days of medication

Study Arms (2)

Jinhua Qinggan Granules

EXPERIMENTAL

Participants receive Jinhua Qinggan Granules according to the study protocol.

Drug: Jinhua Qinggan Granules

Placebo

PLACEBO COMPARATOR

Participants receive placebo matched in appearance to JHQG.

Drug: Placebo

Interventions

Placebo DRUG

Placebo granules matched in appearance and administration to Jinhua Qinggan Granules.

Placebo

Jinhua Qinggan Granules DRUG

Jinhua Qinggan Granules administered orally according to the study protocol.

Jinhua Qinggan Granules

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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;
• WBC \> 11.0×109 or NEU% \> 80% or with symptoms of thick sputum and suspected bacterial infection;
• ALT, AST \> 2 ULN or CRE\>ULN;
• Nasal surgery, nasopharyngeal radiotherapy, acute and chronic nasal diseases or abnormal nasal mucosal function (e.g. rhinitis, sinusitis);
• Patients with diseases diagnosed by specific pathogens (e.g. mumps, measles, hemorrhagic fever, typhoid, chicken pox, allergic rhinitis);
• Fever caused by other clearly diagnosed organic diseases outside the respiratory system;
• 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;
• Subjects, who were treated with antivirals, antibiotics, western or traditional medicines for alleviating symptoms of upper respiratory infection within 12 hours before enrollment;
• Allergic individuals and those who are known to be allergic to investigational drugs, including the ingredients of this product, acetaminophen or drug excipients;
• 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;
• Suspected or do have a history of alcohol or drug abuse;
• Participated in other clinical trials or are participating in other clinical trials in the past 3 months;
• Subjects not suitable for enrollment based on investigators' judgment.

Sponsors & Collaborators

• Juxiechang (Beijing) Pharmaceuticals Co., Ltd. Beijing, China.: collaborator
• University of Karachi: lead

Study Sites (1)

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

Karachi, Karachi, 75270, Pakistan

Location

MeSH Terms

Conditions

Common Cold

Interventions

jinhua qinggan granules

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director-International Center for Chemical and Biological Sciences, University of Karachi

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: July 22, 2026
• Study Start: January 24, 2026
• Primary Completion: April 24, 2026
• Study Completion: April 27, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

PA (1)