Human application study of Salvia plebeia R. Br. for solid cancer patients
- Conditions
- Neoplasms
- Registration Number
- KCT0007315
- Lead Sponsor
- Daejeon Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
1. Patients aged 20 to 65 years old.
2. Those who have been diagnosed with solid cancer and have undergone surgery, chemotherapy, radiation therapy, or are currently undergoing or have not received treatment, and who still have residual cancer.
3. Those who can administer the test drug orally.
4. Those who show an activity status of 0~2 in ECOG Performance status
5. A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing and fully understanding the detailed explanation of this human application test.
6. A person who can sufficiently communicate with the examination doctor (or oriental medicine doctor) about their symptoms or quality of life and can fill out a questionnaire.
7. Those who can follow-up during the human application test period.
8. Those with a life expectancy of 3 months or more.
1. Patients with symptomatic and uncontrolled epilepsy, central nervous system metastasis, or other malignancy, or a history of other malignancies within 5 years of the screening visit (However, cured basal or squamous cell skin cancer, cervical cancer, thyroid cancer, prostate cancer, and breast cancer are excluded).
2. Patients with uncontrolled hypertension (diastolic blood pressure>100mmHg or systolic blood pressure>160mmHg) or those with heart disease such as diabetes, active infection, symptomatic congestive heart failure, and unstable angina.
3. Those with uncontrolled pleural effusion, ascites, or pericardial effusion.
4. Those diagnosed by DSM-V who are taking or need to take psychotropic drugs as a major psychotic disorder (excluding insomnia disorder).
5. People with alcoholism or drug dependence.
6. Those with a history of serious drug allergy or hypersensitivity to the product tested for human application (the main ingredient and its components).
7. Women who are pregnant or lactating, who may be pregnant, who are planning to become pregnant, or of childbearing potential who do not agree to choose an appropriate method of contraception.
8. Those who have participated in other human application tests within 6 months of the start of this trial (180 days before the screening visit date) or plan to participate in other human application trials during the trial period.
9. A person who has a medical condition that is judged to affect the test result, or who is judged inappropriate to participate in this human study based on the judgment of the researcher.
10. Those who are or should be doing parenteral nutrition, tube feeding.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method fact-g questionnaire;before and after the tumor markers in the blood test for each carcinoma are compared.
- Secondary Outcome Measures
Name Time Method safety evaluation