Clinical Research Directory

INVESTIGATION OF THE ANTI-NEOPLASTIC EFFECT OF TRISHUL (AYURVEDIC AGENT) ON TUMOUR REGRESSION OF RECTAL CANCER- A PILOT STUDY

Ayurvedic medicines are used extensively in Asia both for benign as well as malignant disease. Despite their widespread use there is scant scientific evidence to prove efficacy. There are anecdotal reports of effectiveness. Patients are often referred to ayurvedic physicians when all other options have been exhausted. We, at the university of Kelaniya , are planning a randomised double blind placebo controlled study to investigate the anticancer effects of an anticancer ayurvedic drug Trishul in patients with rectal cancer. Patients after discussion at the multidisciplinary discussion will be randomised into two groups. One group will receive the active drg and the other will receive matching placebo. This will be additional to the standard treatment advised by the multidisciplinary team. Treatment/Placebo will be started 4 weeks preoperatively and continued for 24 weeks postoperatively. Patients will be followed up in a standard manner. Evidence of any adverse effects, disease recurrence either locally or at a distant site will be recorded. Overall survival and disease free survival will be the primary endpoints.