KCT0004785尚未招募未知
Efficacy and Safety of Bojungikgi-tang for Anorexia in Patients with Colorectal Cancer after Curative Resection and Chemotherapy : A single-arm, Open label, Single cencer Trial
Pusan National University Korean Medicine Hospital0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Adults aged = 19 years
- •2. Subjects who have been confirmed histologically for rectal or colon cancer and completed curative resection and chemotherapy and no further chemotherapy
- •3. Subjects able to intake medicine orally
- •4. Eastern Cooperative Oncology Group (ECOG) performance status score = 2
- •5. Subjects who are suffering from anorexia after curative resection and chemotherapy, and score on the Visual Analog Scale (VAS) for anorexia = 40/100?mm (100mm is the worst anorexia score)
- •6. Subjects who are not taking megestrol acetate for stimulating appetite
- •7. After hearing and fully understanding the detailed description of the clinical trial, Subjects who provide written informed consent for voluntary participation in the trial and observing the precautions
- •8. Subjects who can fully communicate with their medical doctor about their symptoms or quality of life and who can fill out questionnaires.
- •9. Subjects who can follow up during the clinical trial
- •10. Subjects who have life expectancy of 3 months or more
排除标准
- •1. Subjects who have symptomatic and uncontrolled brain or central nervous system metastasis, have other malignancies or with a history of other malignancies within 5 years at the screening visit(Except cured basal or squamous cell skin cancer, cervical epithelial cancer, thyroid cancer, prostate cancer or breast cancer (Cured basal or squamous cell skin cancer, cervical epithelial cancer, thyroid cancer, prostate cancer and breast cancer excluded)
- •2. Total bilirubin level higher than 2.0?/dL
- •3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels higher than 2.5 times the upper limit for normal
- •4. Creatinine level higher than 1.5 times the upper limit for normal
- •5. Subjects who complain of uncontrolled pain = NRS(Numeral Rating Scale) 5 despite the use of analgesics
- •6. Subjects who have uncontrolled hypertension(Diastolic blood pressure>100mmHg or systolic blood pressure>160mmHg), diabetes, active infection or heart diseases such as symptomatic congestive heart failure or unstable angina
- •7. Subjects who took other herbal medicine or other medicines that is used for the same therapeutic purpose of trial medicine or can affect the improvement of anorexia(e.g. corticosteroids, cyproheptadine) or health functional food, food and medical supplies containing main base materials even if it’s not used for the same therapeutic purpose, within 2 weeks at the screening visit
- •8. Subjects with uncontrolled pleural effusion, ascites, pericardial effusion
- •9. Subjects who have a major psychotic disorder diagnosed by DSM-? that is taking or should be taking psychiatry medications(except insomnia)
- •10. Subjects who have alcoholism or drug dependence
- •11. Subjects with a history of serious drug allergies or who have hypersensitivity to the Investigational Product(the main ingredient and its components)
- •12. Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •13. Subjects who are pregnant, breastfeeding, planning to become pregnant or women of childbearing potential who do not agree with the appropriate method of contraception
- •14. Subjects who have participated in other clinical trials within 6 months (180 days prior to screening visit) or plan to participate in other clinical trials during the trial
- •15. Subjects who have a medical condition that is likely to affect results or who are determined to be inappropriate to participate in this clinical trial at the investigator
- •16. Subjects who are or must have parenteral or tube nutrition
研究者
相似试验
尚未招募
不适用
Efficacy and Safety of Bojungikgi-tang for Anorexia in Lung Cancer Patients with treated with Chemotherapy: A Single-arm, Open label, Single center TrialKCT0004570Pusan National University Korean Medicine Hospital20
招募中
不适用
Effects of Bojungikgi-tang on anorexic patients with atopic dermatitis: a protocol for a randomized, usual care-controlled, assessor-blinded, parallel, pilot clinical trialDiseases of the skin and subcutaneous tissueKCT0006784Daejeon Korean Medicine Hospital of Daejeon University40
招募中
不适用
Efficacy and Safety of Bojungikgi-tang for Persistent Allergic Rhinitis: Study Protocol for a Randomized, Double-blind, Placebo-controlled, Phase II TrialKCT0006616Daejeon Korean Medicine Hospital of Daejeon University105
已完成
不适用
Efficacy and safety of Rikkunshito for anorexia after total gastrectomyafter total gastrectomyJPRN-UMIN000007686Academic surgery of Chiba university30
已完成
不适用
Safety and efficacy of Bojungikki-tang in advanced NSCLC patients receiving treatment with immune checkpoint inhibitors: A study protocol for a multicenter, double-blind, randomized, placebo-controlled pilot trialNeoplasmsKCT0006689Koera University Guro Hospital30