Adverse Drug EventsNCT01764204
Hospital Intensive Monitoring of Adverse Drug Reactions of Qingkailing Injection In The Next Two Years
An observational study of Adverse Drug Events and Adverse Drug Reactions, run by China Academy of Chinese Medical Sciences at 48 sites in China.
Trial summary
To highlight the incidence of adverse reactions of Qingkailing Injection. Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Adverse Drug Events, Adverse Drug Reactions
- What is being tested?
- Qingkailing Injection
- Type of treatment
- Injection or infusion
- How many people
- 30,840 participants
- Where
- 48 sitesChina
- Study dates
- Jan 2013to Jan 2018
- 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 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all the patients treated by Qingkailing Injection in the certain centers(hospitals) in the next 2 years.
Who may be able to join
- all the patients treated by Qingkailing Injection in the certain centers(hospitals) in the next 2 years.
- in accordance with ethics requirements.
Who cannot join
- none.
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
China48 sites
Chinese Medicine Hospital of Gaoyang County
Baoding, Hebei, 071599
Gaoyang County Hospital
Baoding, Hebei, 071599
The Third People's Hospital of Xiong County
Baoding, Hebei, 071802
Chinese Medicine Hospital of Xiong County
Baoding, Hebei, 071899
Chinese Medicine Hospital of Tang County
Baoding, Hebei, 072350
People's Hospital of Tang County
Baoding, Hebei, 072350
National Defense University Hospital of People's Liberation Army
Beijing, Beijing Municipality, 100094
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001
Chinese Medicine Hospital of Handan City
Handan, Hebei, 056001
The First Hospital of Yongnian District
Handan, Hebei, 057150
The Second Hospital of Yongnian District
Handan, Hebei, 057150
The Second Hospital of Bayan County
Harbin, Heilongjiang, 151801
Central Hospital of Liaocheng City
Liaocheng, Shandong, 252001
Veterans'Hospital
Liaocheng, Shandong, 252003
Chinese Medicine Hospital of Dongchangfu District
Liaocheng, Shandong, 252027
Chinese Medicine Hospital of Chiping County
Liaocheng, Shandong, 252100
YangGuXian People's Hospital
Liaocheng, Shandong, 252300
Chinese Medicine Hospital of Linqing
Liaocheng, Shandong, 252661
Chinese Medicine Hospital of Gaotang County
Liaocheng, Shandong, 252800
Luohe Hospital of Chinese Medicine
Luohe, Henan, 462099
People's Hospital of Fuyuan County
Qujing, Yunnan, 655500
Chinese Medicine Hospital of Luliang County
Qujing, Yunnan, 655600
People's Hospital of Luliang County
Qujing, Yunnan, 655600
Chinse Medical Hospital of Shizong County
Qujing, Yunnan, 655700
Central Hospital of Sanmenxia City
Sanmenxia, Henan, 472000
People's Hospital of Shan County
Sanmenxia, Henan, 472100
The First People's Hospital of Lingbao
Sanmenxia, Henan, 472500
Ren'ai Hospital
Shenzhen, Guangdong, 518000
Central Hospital of Shijiazhuang City
Shijiazhuang, Hebei, 050011
Hebei Chest Hospital
Shijiazhuang, Hebei, 050041
Chinese Medicine Hospital of Shijiazhuang City
Shijiazhuang, Hebei, 050061
Community Health Center of Duqiao
Weinan, Shanxi
Chinese Medicine Hospital of Sanyuan County
Xianyang, Shanxi, 713800
Central Hospital of Qinghe County
Xingtai, Hebei, 054000
Chinese Medicine Hospital of Xingtai City
Xingtai, Hebei, 054001
Eye Hospital of Xingtai City
Xingtai, Hebei, 054001
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei, 054099
Chinese Medicine Hospital of Qinghe County
Xingtai, Hebei, 054800
Chinese Medicine Hospital of Xinxiang City
Xinxiang, Henan, 453003
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453003
People's Hospital of Yanjin County
Xinxiang, Henan, 453200
Chinese Medicine Hospital of Fengqiu County
Xinxiang, Henan, 453300
People's Hospital of Fengqiu County
Xinxiang, Henan, 453399
People's Hospital of Yuanyang County
Xinxiang, Henan, 453500
People's Hospital of Xinzheng City
Xinzheng, Henan, 451100
Chinese Medicine Hospital of Deqing County
Zhaoqing, Guangdong, 526600
Third Affiliated Hospital of Henan College of Traditional Chinese Medicine
Zhengzhou, Henan, 450008
Chinese Medicine Hospital of Xinzheng
Zhengzhou, Henan, 451199
About this study
Official title: Intensive Hospital-based Adverse Drug Reaction Monitoring Study On Patients Treated By Qingkailing Injection In The Next Two Years
To highlight the incidence of adverse reactions of Qingkailing Injection.
- Conditions
- Adverse Drug Events, Adverse Drug Reactions
- Being tested
- Qingkailing Injection
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qingkailing InjectionDrug
Also called Shineway Qingkailing Injection
Qingkailing Injection is a kind of natural product injection made from Chinese herbs, which has been used to treat cerebral ischemia for decades in China. The main bioactive ingredients of this injection include Baicalin, Jasminoidin, Ursodeoxycholic Acid, Concha Margaritifera,etc.
| Study group | Role | What they receive |
|---|---|---|
| Qingkailing Injection | Not described Receives: Drug: Qingkailing Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of severe adverse drug reactions
Measured: 2 years
Secondary outcomes (1)
incidence of adverse drug reactions
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug EventsStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,840 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhong Wang, China Academy of Chinese Medical Sciences
- Investigators
- Zhong Wang, Ph.D., M.D., Principal investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764204
- Sponsor's protocol ID
- Qingkailing-V5.0
- Status last verified
- Feb 2018
- First submitted
- 7 Jan 2013
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yao Q, Wei T, Qiu H, Cai Y, Yuan L, Liu X, Li X. Epigenetic Effects of Natural Products in Inflammatory Diseases: Recent Findings. Phytother Res. 2025 Jan;39(1):90-137. doi: 10.1002/ptr.8364. Epub 2024 Nov 8.
PubMed 39513382
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Hospital-based Adverse Drug Reaction Monitoring Study On Patients Treated By Qingkailing Injection In The Next Two Years
- ClinicalTrials.gov ID
- NCT01764204
- Acronym / sponsor ID
- Qingkailing-V5.0
- Conditions
- Adverse Drug Events, Adverse Drug Reactions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,840 participants (actual)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 9 Jan 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.
To highlight the incidence of adverse reactions of Qingkailing Injection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qingkailing Injection | – | Drug: Qingkailing Injection |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all the patients treated by Qingkailing Injection in the certain centers(hospitals) in the next 2 years.
Key inclusion criteria (2 listed)
- all the patients treated by Qingkailing Injection in the certain centers(hospitals) in the next 2 years.
- in accordance with ethics requirements.
Key exclusion criteria (1 listed)
- none.
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 |
|---|---|---|
| Qingkailing InjectionAlso: Shineway Qingkailing InjectionQingkailing Injection is a kind of natural product injection made from Chinese herbs, which has been used to treat cerebral ischemia for decades in China. The main bioactive ingredients of this injection include Baicalin, Jasminoidin, Ursodeoxycholic Acid, Concha Margaritifera,etc. | Drug | Qingkailing Injection |
Primary outcome
incidence of severe adverse drug reactions
Time frame: 2 years
1 secondary outcome
incidence of adverse drug reactions
Time frame: 2 years
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 19 Feb 2018.
- Derived from this study: PubMed 39513382Yao Q, Wei T, Qiu H, Cai Y, Yuan L, Liu X, Li X. Epigenetic Effects of Natural Products in Inflammatory Diseases: Recent Findings. Phytother Res. 2025 Jan;39(1):90-137. doi: 10.1002/ptr.8364. Epub 2024 Nov 8.
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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.
Zhong Wang, Ph.D., M.D. principal investigator
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Events and Adverse Drug Reactions, run by China Academy of Chinese Medical Sciences at 48 sites 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 2 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: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites 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?
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?
incidence of severe adverse drug reactions (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01764204, which also lists 1 linked publication.
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 19 Feb 2018.