Acute RhinitisPhase 3(JHQG-AURI)NCT07720583
Efficacy and Safety of Jinhua Qinggan Granules (JHQG) for the Use of Acute Upper Respiratory Infection
A Phase 3 study testing Jinhua Qinggan Granules in people with Acute Rhinitis and Acute Pharyngitis, run by University of Karachi at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Rhinitis, Acute Pharyngitis, Acute Tonsillitis
- What is being tested?
- Jinhua Qinggan Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 546 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Jan 2026to 27 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with AURI;
- Wind-heat of TCM pattern differentiation;
- 18 ≤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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Karachi, Karachi, 75270
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Acute Rhinitis, Acute Pharyngitis, Acute Tonsillitis, Acute Sinusitis
- Being tested
- Jinhua Qinggan Granules, Placebo
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jinhua Qinggan GranulesDrug
Jinhua Qinggan Granules administered orally according to the study protocol.
PlaceboDrug
Placebo granules matched in appearance and administration to Jinhua Qinggan Granules.
| Study group | Role | What they receive |
|---|---|---|
| Jinhua Qinggan Granules | Experimental | Participants receive Jinhua Qinggan Granules according to the study protocol. Receives: Drug: Jinhua Qinggan Granules |
| Placebo | Placebo comparator | Participants receive placebo matched in appearance to JHQG. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: After 3 Days
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 (%)
Measured: 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 (%)
Measured: After 3 days of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start24 Jan 2026
- Primary completion24 Apr 2026
- Study completion27 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Collaborators
- Juxiechang (Beijing) Pharmaceuticals Co., Ltd. Beijing, China.
- Responsible party
- Principal investigator, Dr. Muhammad Raza Shah, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720583
- Sponsor's protocol ID
- CRO-010-TCM-JHQG-2023
- Acronym
- (JHQG-AURI)
- Status last verified
- Jul 2026
- First submitted
- 23 Dec 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07720583
- Acronym / sponsor ID
- (JHQG-AURI) / CRO-010-TCM-JHQG-2023
- Conditions
- Acute Rhinitis, Acute Pharyngitis, Acute Tonsillitis, Acute Sinusitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- Juxiechang (Beijing) Pharmaceuticals Co., Ltd. Beijing, China.
- Study start
- 24 Jan 2026 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- 27 Apr 2026 (actual)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jinhua Qinggan Granules | Experimental | Drug: Jinhua Qinggan GranulesParticipants receive Jinhua Qinggan Granules according to the study protocol. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive placebo matched in appearance to JHQG. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with AURI;
- Wind-heat of TCM pattern differentiation;
- 18 ≤Age ≤ 65;
- At screening, axillary temperature ≥37.3 ºC and ≤39.0 ºC;
- At randomization and group assignment, disease course within 48 hours;
Key exclusion criteria (13 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jinhua Qinggan GranulesJinhua Qinggan Granules administered orally according to the study protocol. | Drug | Jinhua Qinggan Granules |
| PlaceboPlacebo granules matched in appearance and administration to Jinhua Qinggan Granules. | Drug | Placebo |
Primary outcome
Clinically Curative Rate after 3 days of medication
Time frame: After 3 Days
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).
6 secondary outcomes
Curative effect
Time frame: After 3 days of medication
Change from Baseline in Total Symptom Severity Score
Time frame: Baseline to after 3 days of medication
Time to Defervescence
Time frame: From first dose up to Day 3
Time to Recovery of Individual
Time frame: From first dose up to Day 3
Improvement in Individual Symptoms
Time frame: Baseline to after 3 days of medication
Proportion of Participants Using Acetaminophen
Time frame: After 3 days of medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Jinhua Qinggan Granules in people with Acute Rhinitis and Acute Pharyngitis, run by University of Karachi at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Curative Rate after 3 days of medication (time frame: After 3 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.