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Investigating the Efficacy and Safety of the Combination Treatment of Huaier Granule and Biliary Drainage for MOJ

Obstructive Jaundice Clinical Trial

Official title:
A Multisite, Open-label, Prospective Cohort Study Investigating Huaier Granule Combined With Biliary Drainage for Treatment of Malignant Obstructive Jaundice（MOJ）

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03491254
Study type Observational
Source Shengjing Hospital
Contact zhaoyu liu, Professor
Phone +0086-18940251226
Email liuzhaoyu001@sina.com
Status Not yet recruiting
Phase
Start date May 30, 2018
Completion date May 31, 2021
View Details
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