Clinical Trial for the Evaluation of the Efficacy and Safety of Novel Proprietary Herbal Formula for wome
- Conditions
- Diseases of the genitourinary system
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 100
1) Female over 19 years oldand under 45 years old
2) Female with menstraul cycle range of 24 days or more and 35 days or less at least for the latest 6 months
3) Those with 16 or higher an average DSR score for 6 days right before menstruation during the two consecutive menstrual cycles between Visit 1 and Visit 2(Calculate scores with at least 3 days of data acquisition)
4) Those who agrees to participate in the study voluntarily and sign the informed consents form
1) A person currently being treated for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary systems, kidney and urology, nervous, mental, infectious diseases and malignant tumors
2) A person who has severe migraines, has been diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or has undergone coronary angioplasty within a year
3) A person with severe mental illness such as depression and anxiety disorders or those who are currently taking neuropsychiatric drugs such as antidepressants
4) A person with anemia
5) Those with a history of endometrial proliferation, uterine cancer, endometrial cancer, suspected case of breast cancer or breast disease, sex hormone-related cancer, or those with gynecological conditions such as cysts, fibroids, and malignancies (In case of clinically stable subjects who have a history of cysts and fibroids can participate in the study according to investigator's opinion.)
6) Those with undiagnosed uterine bleeding
7) A person undergoing infertility treatment
8) Menopausal women, who have undergone infertility surgery, hysterectomy, ovarian resection
9) A person on hormonal contraception at the time of Visit 1
10) A person who has a problem in taking Investigational product due to a gastrointestinal disorder
11) A women who drank alcohol equivalent to an average more than 20g per day(140g per week) during one month(30days) right before Visit 1
12) A smoker or a person whose smoking cessation period is less than 6 months
13) A person who has taken drugs and health functional foods that affect Premenstrual Syndrome during one month (30days) right before Visit 1
14) Those whose serum creatinine is 3 times or more than the upper normal limit of the study institution
15) Those whose AST(GOT) or ALT(GPT) is more than 3 times or more than the upper normal limit of the study institution
16) Patient with uncontrolled hypertension(systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher measured after 10minutes resting of subject)
17) Uncontrolled diabetics (over 180 mg/dL of fasting blood sugar)
18) Those who with a TSH level 0.1 µIU/mL or less, or 10 µIU/mL or more
19) A person who is pregnant, lactating or planning to become pregnant within 3 months
20) Those who has participated in any other interventional clinical trial during 3 months right before Visit 1 or plans to participate after the start of this clinical trial
21) A person who is sensitive to or allergic to ingredients of investigational product for this clinical trial
22) A person who has been deemed unfit by investigator for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method