COVID-19 PneumoniaNCT05778318
Efficacy of Lianhua Qingwen in Treating Patients Infected With the Omicron Variant of the COVID-19
An observational study of COVID-19 Pneumonia, run by Qianfoshan Hospital at 1 site in China.
Trial summary
A retrospective analysis was conducted on patients infected with the Omicron variant of COVID-19 diagnosed from August 2022 to now. Patients were divided into observation groups and control groups according to whether or not oral Lianhua Qingwen granules were used. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- The group of patients who received Lianhua Qingwen orally and The group of patients who did not receive Lianhua Qingwen orally
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2023to 30 Jun 2024
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ① For patients infected with the Omicron variant of COVID-19, the diagnostic criteria are confirmed cases of COVID-19 and clinical classification according to the diagnostic criteria of Prevention and Control Protocol for Novel Coronavirus Pneumonia (Trial Eighth Edition) issued by the National Health and Construction Commission; ② The clinical symptoms were classified as mild or ordinary; ③ They have been vaccinated against the COVID-19.
Who may be able to join
- For patients infected with the Omicron variant, the diagnostic criteria are confirmed cases of COVID-19 and clinical classification according to the diagnostic criteria of Prevention and Control Protocol for COVID-19 (Trial Eighth Edition) issued by the National Health and Construction Commission.
- The clinical symptoms were classified as mild or ordinary.
- They have been vaccinated against the COVID-19.
Who cannot join
- Patients receiving antiviral or antibiotic drugs
- Severe and critical patients with COVID-19.
- Patients with chronic respiratory diseases, bacterial infections of the respiratory system, and other respiratory diseases affecting the study.
- Patients with serious primary diseases of the heart, brain, lung, liver, kidney, and hematopoietic systems, as well as mental diseases.
- Allergic reaction to Lianhua Qingwen granules.
- Excluded patients treated with the same drug as Lianhua Qingwen.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
Jinan, Shandong
Qian Qi, Dr., +86 13706380314, qiqianqlh@163.com
About this study
A retrospective analysis was conducted on patients infected with the Omicron variant of COVID-19 diagnosed from August 2022 to now. Patients were divided into observation groups and control groups according to whether or not oral Lianhua Qingwen granules were used. Through data analysis and follow-up, the effectiveness of Lianhua Qingwen in treating patients infected with the Omicron variant of COVID-19 was discussed.
- Conditions
- COVID-19 Pneumonia
- Being tested
- The group of patients who received Lianhua Qingwen orally, The group of patients who did not receive Lianhua Qingwen orally
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group of patients who received Lianhua Qingwen orallyDrug
Lianhua Qingwen Granules: oral. One bag at a time, three times a day. The course of treatment for mild and ordinary cases of novel coronavirus pneumonia is 7-10 days.
The group of patients who did not receive Lianhua Qingwen orallyOther
The group of patients who did not receive Lianhua Qingwen orally.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Patients without Lianhua Qingwen treatment. Receives: Other: The group of patients who did not receive Lianhua Qingwen orally | |
| Observation Group | Patients with Lianhua Qingwen treatment. Receives: Drug: The group of patients who received Lianhua Qingwen orally |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disappearance rate of symptoms
Disappearance rate of symptoms (fever, fatigue, cough)
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start20 Mar 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Qi, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778318
- Sponsor's protocol ID
- YXLL-KY-2022(095)
- Status last verified
- May 2023
- First submitted
- 20 Mar 2023
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lianhua Qingwen in Treating Patients Infected With the Omicron Variant of the COVID-19
- ClinicalTrials.gov ID
- NCT05778318
- Acronym / sponsor ID
- YXLL-KY-2022(095)
- Conditions
- COVID-19 Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 21 Mar 2023 (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.
A retrospective analysis was conducted on patients infected with the Omicron variant of COVID-19 diagnosed from August 2022 to now. Patients were divided into observation groups and control groups according to whether or not oral Lianhua Qingwen granules were used. Through data analysis and follow-up, the effectiveness of Lianhua Qingwen in treating patients infected with the Omicron variant of COVID-19 was discussed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: The group of patients who did not receive Lianhua Qingwen orallyPatients without Lianhua Qingwen treatment. |
| Observation Group | – | Drug: The group of patients who received Lianhua Qingwen orallyPatients with Lianhua Qingwen treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ① For patients infected with the Omicron variant of COVID-19, the diagnostic criteria are confirmed cases of COVID-19 and clinical classification according to the diagnostic criteria of Prevention and Control Protocol for Novel Coronavirus Pneumonia (Trial Eighth Edition) issued by the National Health and Construction Commission; ② The clinical symptoms were classified as mild or ordinary; ③ They have been vaccinated against the COVID-19.
Key inclusion criteria (3 listed)
- For patients infected with the Omicron variant, the diagnostic criteria are confirmed cases of COVID-19 and clinical classification according to the diagnostic criteria of Prevention and Control Protocol for COVID-19 (Trial Eighth Edition) issued by the National Health and Construction Commission.
- The clinical symptoms were classified as mild or ordinary.
- They have been vaccinated against the COVID-19.
Key exclusion criteria (6 listed)
- Patients receiving antiviral or antibiotic drugs
- Severe and critical patients with COVID-19.
- Patients with chronic respiratory diseases, bacterial infections of the respiratory system, and other respiratory diseases affecting the study.
- Patients with serious primary diseases of the heart, brain, lung, liver, kidney, and hematopoietic systems, as well as mental diseases.
- Allergic reaction to Lianhua Qingwen granules.
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 |
|---|---|---|
| The group of patients who received Lianhua Qingwen orallyLianhua Qingwen Granules: oral. One bag at a time, three times a day. The course of treatment for mild and ordinary cases of novel coronavirus pneumonia is 7-10 days. | Drug | Observation Group |
| The group of patients who did not receive Lianhua Qingwen orallyThe group of patients who did not receive Lianhua Qingwen orally. | Other | Control group |
Primary outcome
Disappearance rate of symptoms
Time frame: two weeks
Disappearance rate of symptoms (fever, fatigue, cough)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia, run by Qianfoshan 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 6 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: status not confirmed, as of the sponsor's last update on 11 May 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Qi, Dr. (+86 13706380314, qiqianqlh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disappearance rate of symptoms (time frame: two weeks). 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 11 May 2023.