Phase II Clinical Trial of Uncaria Tomentosa (Cat´s Claw) in Patients With Advanced Solid Tumors
کلید واژه ها
خلاصه
تاریخ
آخرین تأیید شده: | 12/31/2013 |
اولین ارسال: | 01/22/2014 |
ثبت نام تخمینی ارسال شد: | 01/23/2014 |
اولین ارسال: | 01/26/2014 |
آخرین بروزرسانی ارسال شده: | 01/23/2014 |
آخرین به روزرسانی ارسال شده: | 01/26/2014 |
تاریخ شروع مطالعه واقعی: | 11/30/2013 |
تاریخ تخمین اولیه اولیه: | 06/30/2014 |
تاریخ برآورد مطالعه: | 08/31/2014 |
شرایط یا بیماری
مداخله / درمان
Drug: cat's claw
فاز
گروههای بازو
بازو | مداخله / درمان |
---|---|
Experimental: cat's claw 100 mg dose of a dry extract of U. tomentosa three times per day | Drug: cat's claw |
معیارهای صلاحیت
سنین واجد شرایط تحصیل | 18 Years به 18 Years |
جنسیت واجد شرایط مطالعه | All |
داوطلبان سالم را می پذیرد | آره |
شاخص | Inclusion Criteria: - individuals with advanced solid tumors, with no further therapeutic options and with at least 2 moths life expectancy - individuals 18 years of age and older - creatinine levels up to twice the upper limit of normal (ULN) - alanine (ALT) and aspartate (ASP) transaminase levels up to twice the ULN and direct bilirubin (DB) levels up to 1.5 times the ULN - in cases with pre-existing liver disease, the ALT, ASP and DB levels could be up to 2.5 times the ULN Exclusion Criteria: - pregnant and breastfeeding women - individuals using chemotherapy or other tumor-targeting antineoplastic treatments, except for antalgic radiotherapy - severe kidney or liver failure - known hypersensitiveness to the components of the medication used - past history of emotional disorders that could interfere with the data collection. |
نتیجه
اقدامات اولیه
1. assessment of benefits on quality of life after treatment during two months [two months]