A Phase 3 interventional study of Jinhua Qinggan Granules and Placebo in Acute Rhinitis, Acute Pharyngitis and Acute Tonsillitis, sponsored by University of Karachi. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by University of Karachi · Phase 3, Interventional, and Treatment
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:
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:
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.
Exclusion Criteria:
Participants receive Jinhua Qinggan Granules according to the study protocol.
Drug: Jinhua Qinggan Granules
Participants receive placebo matched in appearance to JHQG.
Drug: Placebo
Jinhua Qinggan Granules administered orally according to the study protocol.
Placebo granules matched in appearance and administration to Jinhua Qinggan Granules.
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).
Time frame: After 3 Days
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 (%)
Time frame: 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 (%)
Time frame: After 3 days of medication
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Karachi