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.
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's enrollment of 546 is above the median of 150 across 184 interventional studies indexed under Common Cold.
Browse Common Cold studies →University of Karachi is the lead sponsor of 37 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Jan 2026 to primary completion in Apr 2026, 3 months.
Of 17 phase 3 interventional studies under Common Cold, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
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