A clinical trial to study the effects of Ayurvedic formulation containing Ashwagandha and Guduchi in improving the quality of life in patients of breast cancer receiving chemotherapy as treatment

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2008
INTERVENTION: Intervention1: Tablet PHP‐Cancer containing hydro‐alcoholic extracts of Withania somnifera 150mg and Tinospora cordifolia 200 mg: 500 mg BD for 6 months Control Intervention1: Tablet Placebo: 500 mg BD for 6 months CONDITION: Breast cancer receiving chemotherapy PRIMARY OUTCOME: The primary outcome measures will be 20% improvement in the QOL score over and above that obtained in the group receiving placebo and less than 10% difference in adverse events (including laboratory variables) between placebo and active treatment groups.‐‐‐‐‐‐Timepoint: SECONDARY OUTCOME: Not Applicable‐‐‐‐‐‐Timepoint: INCLUSION CRITERIA: 1. Female patients in age group of 18 to 60 years (irrespective of menopausal status) with a life expectancy of at least 6 months 2. Patients with breast cancer scheduled to receive chemotherapy 3. Patients ready to consent and to abide by trial related procedures
Epistemonikos ID: b734d017b47b90b3e0d061ab4f3c23e6517b5d62
First added on: Aug 21, 2024