Acute Upper Respiratory Tract InfectionPhase 1/2NCT06520618
Clinical Study on the Efficacy and Safety of Qingre Heji in the Treatment of Acute Upper Respiratory Tract Infection
A Phase 1/2 study testing Qing Re He Ji and Shuanghuanglian Oral Liquid in people with Acute Upper Respiratory Tract Infection and Traditional Chinese Medicine, run by Shengjing Hospital at 1 site in China.
Trial summary
Originating from China, TCM complements conventional approaches by alleviating symptoms, balancing physical conditions, and enhancing immunity. Clinical studies have shown TCM to be safe and effective in treating AURI. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Upper Respiratory Tract Infection, Traditional Chinese Medicine, Randomised Controlled Trial
- What is being tested?
- Qing Re He Ji and Shuanghuanglian Oral Liquid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 Feb 2024
- Phase
- Phase 1/2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1: Voluntarily sign informed consent
- 2: Age ≥ 18 years old
- 3: Meet the diagnostic criteria of acute respiratory tract infection: Internal Medicine edited by chenhaozhu (9th Edition, people's Health Publishing House)
Who cannot join
- 1: Legal infectious diseases with upper respiratory symptoms
- 2: Patients with severe pneumonia
- 3: Severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system
- 4: After this episode, he has received other antiviral, anti-inflammatory, antipyretic and analgesic drugs or any other drugs to treat colds
- 5: Pregnant or lactating women
- 6: Allergic constitution and drug allergy
Show all 10Show fewer
- 7: Psychopath
- 8: Those who have participated in other clinical trials within three months
- 9: Persons with a history of drug abuse
- 10: Other circumstances that the investigator believes are not suitable for enrollment
Trial locations and contacts
1 site in 1 country.
China1 site
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110000
About this study
Originating from China, TCM complements conventional approaches by alleviating symptoms, balancing physical conditions, and enhancing immunity. Clinical studies have shown TCM to be safe and effective in treating AURI. In TCM syndrome differentiation, AURI is considered a "Wind-Heat Syndrome", requiring treatment that clears heat and detoxifies the body. Qing Re He Ji (QRHJ; heat-clearing mixture), a TCM compound developed by our hospital, comprises Huang Qin (Radix Scutellariae), Da Qing Ye (Folium Isatidis), Ge Gen (Radix Puerariae), Yin Chen (Herba Artemisiae Scopariae), and Guan Zhong (Cyrtomium Rhizome). Widely used for AURI, QRHJ effectively clears heat, eliminates pathogens, and strengthens healthy qi. Clinical applications have demonstrated its efficacy, complemented by significant advancements in animal experiments and pharmacokinetics research. To further validate these results, systematic clinical research is imperative, especially in the context of limited direct comparisons between QRHJ and other commercially available TCMs like Shuang Huang Lian (SHL) oral liquid, known for its efficacy and safety in AURI treatment.
Therefore, we performed a rigorously designed non-inferiority randomised controlled trial to assess the efficacy and safety of QRHJ in treating AURI in adults, comparing it directly with SHL oral liquid. This study aimed to bridge existing research gaps and provide healthcare professionals with more diversified treatment options, thereby enhancing personalised and comprehensive patient care plans. Furthermore, we hope that our findings will establish a scientific basis for integrating TCM into modern healthcare practices, promoting the synergy of Chinese and Western medicine.
- Conditions
- Acute Upper Respiratory Tract Infection, Traditional Chinese Medicine, Randomised Controlled Trial
- Being tested
- Qing Re He Ji, Shuanghuanglian Oral Liquid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qing Re He JiDrug
Oral administration of Qing Re He Ji
Shuanghuanglian Oral LiquidDrug
Oral administration of Shuanghuanglian Oral Liquid
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Drug: Qing Re He Ji |
| Control Group | Active comparator | Not described Receives: Drug: Shuanghuanglian Oral Liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Symptom and Sign Score Improvement Rate
We use both traditional Chinese medicine (TCM) and Western medicine scales to assess the condition.
Measured: At days 0 (baseline) and 6
Onset time
Defined as the duration from medication administration to a 0.5°C decrease in body temperature.
Measured: At days 0 (baseline) and 6
Antipyretic time
Measured as the time taken for axillary temperature to drop below 37.3°C after the first dose and maintained for at least 24 hours without recurrence
Measured: At days 0 (baseline) and 6
Single Symptom and Sign Disappearance Rate
Disappearance rate of individual TCM symptoms and signs
Measured: At days 0 (baseline) and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Feb 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Naijing, Shengjing Hospital
- Investigators
- Difei Wang, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520618
- Sponsor's protocol ID
- M1112
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: One years after the article was published, disclose the original data if necessary.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of Qingre Heji in the Treatment of Acute Upper Respiratory Tract Infection
- ClinicalTrials.gov ID
- NCT06520618
- Acronym / sponsor ID
- M1112
- Conditions
- Acute Upper Respiratory Tract Infection, Traditional Chinese Medicine, Randomised Controlled Trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 25 Jul 2024 (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.
Originating from China, TCM complements conventional approaches by alleviating symptoms, balancing physical conditions, and enhancing immunity. Clinical studies have shown TCM to be safe and effective in treating AURI. In TCM syndrome differentiation, AURI is considered a "Wind-Heat Syndrome", requiring treatment that clears heat and detoxifies the body. Qing Re He Ji (QRHJ; heat-clearing mixture), a TCM compound developed by our hospital, comprises Huang Qin (Radix Scutellariae), Da Qing Ye (Folium Isatidis), Ge Gen (Radix Puerariae), Yin Chen (Herba Artemisiae Scopariae), and Guan Zhong (Cyrtomium Rhizome). Widely used for AURI, QRHJ effectively clears heat, eliminates pathogens, and strengthens healthy qi. Clinical applications have demonstrated its efficacy, complemented by significant advancements in animal experiments and pharmacokinetics research. To further validate these results, systematic clinical research is imperative, especially in the context of limited direct comparisons between QRHJ and other commercially available TCMs like Shuang Huang Lian (SHL) oral liquid, known for its efficacy and safety in AURI treatment.
Therefore, we performed a rigorously designed non-inferiority randomised controlled trial to assess the efficacy and safety of QRHJ in treating AURI in adults, comparing it directly with SHL oral liquid. This study aimed to bridge existing research gaps and provide healthcare professionals with more diversified treatment options, thereby enhancing personalised and comprehensive patient care plans. Furthermore, we hope that our findings will establish a scientific basis for integrating TCM into modern healthcare practices, promoting the synergy of Chinese and Western medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Qing Re He Ji |
| Control Group | Active comparator | Drug: Shuanghuanglian Oral Liquid |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1: Voluntarily sign informed consent
- 2: Age ≥ 18 years old
- 3: Meet the diagnostic criteria of acute respiratory tract infection: Internal Medicine edited by chenhaozhu (9th Edition, people's Health Publishing House)
Key exclusion criteria (10 listed)
- 1: Legal infectious diseases with upper respiratory symptoms
- 2: Patients with severe pneumonia
- 3: Severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system
- 4: After this episode, he has received other antiviral, anti-inflammatory, antipyretic and analgesic drugs or any other drugs to treat colds
- 5: Pregnant or lactating women
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 |
|---|---|---|
| Qing Re He JiOral administration of Qing Re He Ji | Drug | Experimental Group |
| Shuanghuanglian Oral LiquidOral administration of Shuanghuanglian Oral Liquid | Drug | Control Group |
Primary outcome
Overall Symptom and Sign Score Improvement Rate
Time frame: At days 0 (baseline) and 6
We use both traditional Chinese medicine (TCM) and Western medicine scales to assess the condition.
Onset time
Time frame: At days 0 (baseline) and 6
Defined as the duration from medication administration to a 0.5°C decrease in body temperature.
Antipyretic time
Time frame: At days 0 (baseline) and 6
Measured as the time taken for axillary temperature to drop below 37.3°C after the first dose and maintained for at least 24 hours without recurrence
Single Symptom and Sign Disappearance Rate
Time frame: At days 0 (baseline) and 6
Disappearance rate of individual TCM symptoms and signs
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 25 Jul 2024.
- Individual participant dataSharing planned: No. One years after the article was published, disclose the original data if necessary.
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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.
Difei Wang principal investigator
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Qing Re He Ji and Shuanghuanglian Oral Liquid in people with Acute Upper Respiratory Tract Infection and Traditional Chinese Medicine, run by Shengjing Hospital at 1 site in China.
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 3 inclusion and 10 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 25 Jul 2024. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Overall Symptom and Sign Score Improvement Rate (time frame: At days 0 (baseline) and 6). The study lists 4 primary outcomes in all. 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 25 Jul 2024.