Efficacy and Safety of InSan Bamboo Salt on Improvement of Helicobacter Pylori Infection

Helicobacter Pylori Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735136
• Other study ID #: INSAN-HP-BS
• Status: Completed
• Phase: N/A
• Start date: November 21, 2012
• Est. completion date: July 25, 2013

Study information

• Verified date: August 2019
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators performed a 4-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of InSan Bamboo Salt on improvement of Helicobacter pylori infection. The investigators measured improvement of Helicobacter pylori infection parameters , including 14C-UBT(Urea breath test), and subjects' symptoms, and monitored their blood pressure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 25, 2013
• Est. primary completion date: July 25, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males and females 19-65 years old

• 14C-UBT test = 100 cpm

• Endoscopy results showing gastritis

• Able to give informed consent

Exclusion Criteria:

• Diagnosed of gastrointestinal disease such as ulcer, cancer, more than 10 erosions

• Taken antibiotics and stomach medicines such as steroid, bismuth compound, H2-receptor antagonist and proton pump inhibitor within 2 weeks

• Allergic or hypersensitive to any of the ingredients in the test products

• History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery

• History of alcohol or substance abuse

• Participation in any other clinical trials within past 2 months

• Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study

• Pregnant or lactating women etc.

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Dietary Supplement:
• InSan Bamboo Salt
InSan Bamboo Salt (10g/day)
• Placebo
Placebo (10g/day)

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in 14C-UBT(Urea breath test)	14C-UBT(Urea breath test) was measured in study visit 1(0 week) and visit 3(4 week).	4 weeks
Secondary	Changes in subjects' symptoms	subjects' symptoms was measured in study visit 1(0 week) and visit 3(4 week).	4 weeks