Clinical Trial of Siddha Medicine Nandhi Mezhugu in the Treatment of Breast Cancer
- Conditions
- Health Condition 1: C50- Malignant neoplasm of breastHealth Condition 2: C500- Malignant neoplasm of nipple and areolaHealth Condition 3: C500- Malignant neoplasm of nipple and areola
- Registration Number
- CTRI/2021/10/037630
- Lead Sponsor
- Central Council for Research in Siddha Arumbakkam Chennai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?Radiological objective response to the treatment (Using imaging studies) <br/ ><br>?To establish the safety of Nandhi Mezhugu after treatment <br/ ><br> <br/ ><br>Timepoint: oth day, 56th day <br/ ><br> <br/ ><br>oth day, 56th day
- Secondary Outcome Measures
Name Time Method Changes in Health related Quality of Life (EORTC QLQ-BR23) <br/ ><br>Tumor marker assessment before during & after treatment <br/ ><br>Timepoint: 0th day, 56th day <br/ ><br> <br/ ><br>0th day, 26th day, 56th day