NCT05676164

A Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography

A Multicenter, Prospective, Randomized Controlled Clinical Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Shandong Branden Med.Device Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to verify the safety and efficacy of Oral Contrast Agent for Sonography produced by Shandong Baiduo Medical Instruments Co., LTD.

Detailed description

The goal of this clinical trial is to verify the safety and efficacy of Oral Contrast Agent for Sonography produced by Shandong Baiduo Medical Instruments Co., LTD. Participants will Ultrasound was administered with Oral Contrast Agent for Sonography and observed for 2 days. The investigators will compare Oral Contrast Agent for Sonography produced by Huzhou East Asia Medical Supplies Co., LTD to see if the safety and efficacy of Oral Contrast Agent for Sonography produced by Shandong Baiduo Medical Instruments Co., LTD

Conditions

• Unspecified Disorder of Stomach and Duodenum

Interventions

Type	Name	Description
DEVICE	KANG XIAN	This product is a liquid composed of silica, stabilizer, xylitol, flavoring agent and water. The pH value of the product is 5.0 \~ 8.0, and the total heavy metal content (measured by Pb2+) is less than 10µg/ml.
DEVICE	TIAN XIA	The products are dark yellow granules made from rice, soybean, lotus root powder, orange peel, coix seed and yam.

Timeline

• Start date: 2021-03-31
• Primary completion: 2022-08-22
• Completion: 2022-08-22
• First posted: 2023-01-09
• Last updated: 2023-01-09

Locations

1 site across 1 country: China