Pneumonia;NCT01824732
A Registry Study on Tanreqing（a Chinese Medicine Injection）Used in Hospitals in China
An observational study of Pneumonia; and Bronchitis, run by China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in December 2012. The purpose of this study is to make a event monitoring to see whether Tanreqing injection is safe and the characteristic and mechanism of anaphylactic reaction used Tanreqing… Read more about this study
- Who is it for?
- Ages 1 month to 80 years
- Conditions the study is for
- Pneumonia;, Bronchitis
- Type of treatment
- Injection or infusion
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Apr 2013
- How long will I take part?
- 15 Days
- 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 1 month to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: An anticipated sample size was caculated in this study, about 3000 Patients using Tanreqing injection from January to March 2013 in hospitals.
Who may be able to join
- Patients using Tanreqing injection from January to March 2013
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Basic Research in Clinical Medicine
Beijing, Beijing Municipality, 100700
Chang Y Peng, Doctor, 010-64014411 ext. 2802, cyp2668@163.com
Xie M Yan, BA
About this study
Official title: a Study of Clinical Safety Monitoring and the Mechanism of Anaphylactic Reaction Used Tanreqing(a Chinese Medicine Injection)in Hospitals in China
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in December 2012.
The purpose of this study is to make a event monitoring to see whether Tanreqing injection is safe and the characteristic and mechanism of anaphylactic reaction used Tanreqing injection in hospitals in China.
Read the detailed description
It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.
In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Tanreqing injection safety surveillance with 3000 patients will be conducted from Jan.2013 to Mar.2013.At the same time,Patients who have anaphylactic reaction are selected as the allergic group and not have anaphylactic reaction are selected as the control group.The proportion of allergic group and control group is 1:4.All the patients who are selected should draw blood.
Eligibility criteria Patients who will use Tanreqing injection in selected hospitals.
- Conditions
- Pneumonia;, Bronchitis
- Medical subject headings
- Pneumonia, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Allergic group | All patients who used Tanreqing Injection have anaphylaxis. | |
| Control group | All patients who used Tanreqing Injection don't have anaphylaxis.One allergic group patient should matched four control group patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with anaphylactic reaction;the blood of participants with anaphylactic reaction
Measured: to assess Tanreqing's 'anaphylactic reaction' .during patients' hospital stay, administration information of Tanreqing will be registered every day. The registry procedure will last 3 month only for patients using Tanreqing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia;Studies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanming Xie, China Academy of Chinese Medical Sciences
- Investigators
- Xie Y Ming, BA, Principal investigator, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824732
- Sponsor's protocol ID
- 200907001-5-6-2
- Status last verified
- Apr 2013
- First submitted
- 30 Mar 2013
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Study of Clinical Safety Monitoring and the Mechanism of Anaphylactic Reaction Used Tanreqing(a Chinese Medicine Injection)in Hospitals in China
- ClinicalTrials.gov ID
- NCT01824732
- Acronym / sponsor ID
- 200907001-5-6-2
- Conditions
- Pneumonia;, Bronchitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 5 Apr 2013 (estimated)
- 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.
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in December 2012.
The purpose of this study is to make a event monitoring to see whether Tanreqing injection is safe and the characteristic and mechanism of anaphylactic reaction used Tanreqing injection in hospitals in China.
Detailed description
It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.
In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Tanreqing injection safety surveillance with 3000 patients will be conducted from Jan.2013 to Mar.2013.At the same time,Patients who have anaphylactic reaction are selected as the allergic group and not have anaphylactic reaction are selected as the control group.The proportion of allergic group and control group is 1:4.All the patients who are selected should draw blood.
Eligibility criteria Patients who will use Tanreqing injection in selected hospitals.
Study design
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergic group | – | –All patients who used Tanreqing Injection have anaphylaxis. |
| Control group | – | –All patients who used Tanreqing Injection don't have anaphylaxis.One allergic group patient should matched four control group patients. |
Who may qualify
- Ages
- 1 month to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- An anticipated sample size was caculated in this study, about 3000 Patients using Tanreqing injection from January to March 2013 in hospitals.
Key inclusion criteria (1 listed)
- Patients using Tanreqing injection from January to March 2013
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with anaphylactic reaction;the blood of participants with anaphylactic reaction
Time frame: to assess Tanreqing's 'anaphylactic reaction' .during patients' hospital stay, administration information of Tanreqing will be registered every day. The registry procedure will last 3 month only for patients using Tanreqing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
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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.
Xie Y Ming, BA principal investigator
China Academy of Chinese Medical Sciences
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 Pneumonia; and Bronchitis, run by China Academy of Chinese Medical Sciences 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 1 inclusion and 1 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 5 Apr 2013. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with anaphylactic reaction;the blood of participants with anaphylactic reaction (time frame: to assess Tanreqing's 'anaphylactic reaction' .during patients' hospital stay, administration information of Tanreqing will be registered every day. The registry procedure will last 3 month only for patients using Tanreqing). 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 5 Apr 2013.