Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C500- Malignant neoplasm of nipple and areola Health Condition 3: C500- Malignant neoplasm of nipple and areola
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients in the age group of 18- 60 years 2. Patients with histologically/cytologically confirmed carcinoma of the breast of stages I & II. 3. Patient willing to take siddha medicine 4. Patients ready to consent and to abide to trial related procedures
Exclusion criteria
Exclusion criteria: 1. Patient willing to take chemotherapy/radiotherapy/ undergo surgery/ any other alternative medicines 2. Patients who have received prior chemotherapy/ hormonal therapy/ investigational drugs/ alternative therapies for the treatment of breast cancer within last 1 month 3. Patients who have under gone surgery for stage I & II breast cancer 4. Patients with stage III and IV (who are with distant metastasis at diagnosis) 5. Patients with severe illness 6. Patients with significant existing breast trauma 7. Patients with abnormal renal & liver functions 8. Confirmed diagnosis of HIV or Hepatitis B/C 9. Inability to comply with the study protocol 10. Pre-menopausal female patients who are pregnant, lactating or of reproductive potential and not employing effective birth control measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?Radiological objective response to the treatment (Using imaging studies) ?To establish the safety of Nandhi Mezhugu after treatment Timepoint: oth day, 56th day oth day, 56th day | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Health related Quality of Life (EORTC QLQ-BR23) Tumor marker assessment before during & after treatment Timepoint: 0th day, 56th day 0th day, 26th day, 56th day | — |
Countries
India
Contacts
Central Council for Research in Siddha