human trial to evaluate the efficacy and safety of SGE-107 on halitosis accompanied by gastrointestinal symptoms
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0007241
- Lead Sponsor
- scare Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
1) Adult men and women aged 19 to 65 years to 65 or younger
2) any of the following persons
A. Those whose H2S value in VSC concentration is 1.5 ng or more or whose CH3SH value is 0.5 ng or more
or
B. Those who have experienced bad breath within the past three months and have 3 or more VAS points
3) Those who have experienced mild indigestion within the past three months
4) Participate voluntarily after listening to the detailed explanation of this human body application test and fully understanding it.
a person who has made a written agreement to make a decision and observe the precautions
1) Subjects who experienced adverse reactions such as allergies when taking medicines and health functional foods
2) A person who is currently being treated or has a history of past history due to systemic diseases (hepatic disease, kidney disease, Sjogren's syndrome, rheumatoid disease), etc. that may cause bad breath.
3) Those with severe dental diseases ( periodontal inflammation, dental caries) (enamental caries among dental caries can participate in the examination)
4) Those who take drugs that may affect research, such as antibiotics, bismuth compound, H2 receptor antagonists, proton pump inhibitors, mucosal protectors, and foods containing the same raw material as test foods, may participate in the test if other conditions are appropriate.)
5) Those with a potentially organic cause of gastrointestinal discomfort (active peptic ulcer, hemorrhagic gastritis, gastric cancer, esophageal cancer, pancreatic disease, inflammatory bowel disease, etc.) within three months of screening.
6) Those with uncontrolled hypertension (measurement criteria after 5 minutes of rest for test subjects, 160/100 mmHg or more)
7) Diabetes patients with fasting blood sugar of 160 mg/dl or higher or oral hypoglycemic agents or inadequate insulin response
8) Subjects diagnosed with dementia, brain tumors, and chickenpox, or who have undergone hormone replacement therapy within 3 months of visit 1 or are in progress.
9) A person who is pregnant or lactating or has a pregnancy plan during this study.
10) Those who are sensitive or allergic to this human-applied test food
11) Those who have abnormalities in the following diagnostic medical examination results
- If AST/ALT exceeds the upper limit of the normal range by three times.
- If Serum Creatine is more than twice the upper limit of the normal range.
12) A person who is currently participating in another human application or clinical trial under R&D other than this human application test, or who has participated in another clinical trial within 4 weeks prior to the screening test.
13)Other persons who are unable to participate in clinical trials at the discretion of the researcher.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual Analogue Scale(VAS)
- Secondary Outcome Measures
Name Time Method Halitosis associated life-quality test(HALT);Volatile sulfur compounds, Salitary Flow Rate,Tongue plaque index, Winkle tongue coating index, Mucus;Gastrointestinal Symptom Rating Scale(KGSRS);Digital Infrared Thermal Imaging(DITI)