Clinical Trial for the Evaluation of the Efficacy and Safety of MJBIO-002 on Vaginal Health
- Conditions
- Not Applicable
- Registration Number
- KCT0004975
- Lead Sponsor
- Konkuk University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1) Women of childbearing age over 19 years of age and under 50 years of age
2) A person with a score of 4-6 on the Nugent core.
3) A person who agrees to participate in the human application test before the human application test begins and has prepared the written consent form.
1) The subjects who have severe malignant tumors, cerebrovascular diseases (brain infarction, cerebral hemorrhage, etc.) and heart diseases (concerns, myocardial infarction, heart failure, arrhythmia requiring treatment) can participate in the human application test at the discretion of the human application tester.)
2) The subjects who has a vaginal and urinary tract infection as of Visit 1
3) The subjects with vaginal bleeding, abnormal vaginal secretion, or urinary system abnormality as of the standard of Visit1
4) The subjects who has been given antibiotics, antibacterial agents, steroids, and immunosuppressants within two weeks of visiting1
5) The subjects who has ingested health functional foods, probiotics, and lactobacillus products continuously (more than four times a week) within two weeks of visiting 1
6) A person who has received acupuncture treatment for women's cleanser, vaginal cleanser, sedentary treatment and vaginal health within one week of visiting 1
7) The subjects with unregulated hypertension (measuring standard after 10 minutes stabilization of the person subject to human application test) (above 160mmHg of blood pressure in the retractor or 100mmHg of blood pressure in the retractor).
8) Unregulated diabetics (if HbA1C exceeds 6.3%)
9) The subjects whose creatine is more than twice the normal limit of the testing agency
10) The subjects whose AST (GOT) or ALT (GPT) is at least three times the normal limit of the testing agency
11) The subjects whose TSH is less than 0.1 UU/ml or greater than 10 µU/ml
12) The subjects who are sensitive or allergic to the ingredients of this human-applied test food;
13) The subjects who is pregnant, breast-feeding, or planning to conceive within three months.
14) The subjects who has participated in another interventional clinical trial (including a human application test) within one month of the commencement of this human application test or who has a plan to participate in another interventional clinical trial (including a human application test) after the commencement of this human application test.
15) The subjects who is deemed inappropriate by the human application test testers for this human application test.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ugent Score
- Secondary Outcome Measures
Name Time Method Vaginal pH;Vaginal microflora;Symptom Survey Assessment