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NCT01812876
A Registry Study on Shenqifuzheng（a Chinese Medicine Injection）Used in Hospitals in China
trial in Gastric Carcinoma in 30,000 participants. Status unknown.
1 December 2014
Quick facts
| Lead sponsor | China Academy of Chinese Medical Sciences |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 30,000 |
| Start date | 1 December 2012 |
| Primary completion | 1 December 2014 |
| Estimated completion | 1 December 2015 |
Conditions studied
- Gastric Carcinoma — all drugs for Gastric Carcinoma →
- Carcinoma of the Lungs — all drugs for Carcinoma of the Lungs →
Sponsor
China Academy of Chinese Medical Sciences — full company profile →
Who can join
18 and older, any sex, with Gastric Carcinoma or Carcinoma of the Lungs. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of participants with adverse events; incidence of Shenqifuzheng'ADRs and identify factors that contributed to the occurrence of the adverse reaction
Time frame: to assess Shenqifuzheng's 'adverse event' and 'drug adverse reaction' during patients' hospital stay, administration information of Shenqifuzheng will be registered every day. The registry procedure will last 3 years only for patients using Shenqifuzheng
All patients will be measured and assessed at the time Shenqifuzheng is administered to them until they discharge. Patients using Shenqifuzheng will be registered on a registration form including disease background, Shenqifuzheng's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted sy
Sponsor's own description
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in December 2012. It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'. The purpose of this study is to make a cohort event monitoring to see whether and how Shenqifuzheng injection in hospital results in adverse events or adverse drug reactions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01812876
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other China Academy of Chinese Medical Sciences trials
Trials by the same sponsor.
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- NCT04932395 — Anshen Buxin Liuwei Pills for the Treatment of Cardiac Neurosis · Phase 4 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01812876 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by China Academy of Chinese Medical Sciences
- Last refreshed: 15 April 2013
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01812876.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing