Trials / Unknown
UnknownNCT03491254
Investigating the Efficacy and Safety of the Combination Treatment of Huaier Granule and Biliary Drainage for MOJ
A Multisite, Open-label, Prospective Cohort Study Investigating Huaier Granule Combined With Biliary Drainage for Treatment of Malignant Obstructive Jaundice（MOJ）
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 852 (estimated)
- Sponsor
- zhaoyu liu · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- —
Summary
This study is designed to evaluate the efficacy and safety of the combination treatment of Huaier granule and biliary drainage for malignant obstructive jaundice.
Detailed description
After sign the informed consent, the, eligible patients are those who have completed the examinations within 2 weeks after the biliary drainage will enter the study and visit the study sites at Weeks 12, 24, 36, and 48. The follow-up duration is up to 48 weeks or until the death of patient during the study. The patients will be allocated to two groups based on whether being exposed to Huaier granule or not. Study data will be collected prospectively, including the patients' baseline characteristics, chemo-/radio-therapy history, previous Huaier granule treatment, laboratory tests, imaging examinations, and various clinical endpoints including liver function, quality of life, status of survival, and safety. This is a non-interventional study in patient population in real world. Therefore, the patients' treatment regimen will not be interfered, i.e., the patients will independently decide whether to take Huaier granule or not based on the recommendation from the clinician after the drainage. The patients will be allocated into different groups completely according to their treatment at clinic in real world. During the study, only the study required data and endpoints will be collected.
Conditions
Timeline
- Start date
- 2018-05-30
- Primary completion
- 2020-11-30
- Completion
- 2021-05-31
- First posted
- 2018-04-09
- Last updated
- 2018-04-24
Source: ClinicalTrials.gov record NCT03491254. Inclusion in this directory is not an endorsement.