A study of Ayurvedic Arsenic compound (Somal) in treatment of solid tumors.
Not Applicable
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2018/04/013086
- Lead Sponsor
- Rasayani Biologics Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
•Male or female patient with solid tumours aged 20 to 70 of solid tumours
•All those patients who have not responded to conventional anticancer therapies.
•Cancer Patients who are not willing to take chemotherapy
•Cancer patients who are eligible to receive treatment of Somal.
•Cancer Patients who has expected survival of more than 3 months
Exclusion Criteria
1.Patients taking Chemotherapy.
2.Patients taking conventional products containing Arsenic.
3.Patient with deranged hepatic or renal profile at baseline.
4.Patients with Pre-existing cardiac illness.
5.Patients who has ECOG performance is >= 2.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Pet scan /CT Scan /MRI Scan at baseline (Day 0) and post interventional (Day 90) <br/ ><br>2. Quality of life assessment using validated questionnairesâ?? at baseline and 15 days intervals (FACT-G). <br/ ><br>3. ECOG Performance status after every 15 days. <br/ ><br> <br/ ><br>Timepoint: 1.Pet scan /CT Scan /MRI Scan at baseline (Day 0) and post interventional (Day 90) <br/ ><br>2. Quality of life assessment using validated questionnairesâ?? at baseline and 15 days intervals (FACT-G). <br/ ><br>3. ECOG Performance status after every 15 days. <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Whole Blood For Arsenic Concentration <br/ ><br>2. Electrocardiograph. <br/ ><br>3. Complete Blood Count <br/ ><br>4. Liver Function Test <br/ ><br>5. Renal Function Test <br/ ><br>Timepoint: 1. Detection of Arsenic concentration in blood Day,30,60 and 90. <br/ ><br>2. Effect on heart â??Electrocardiograph will be done on day 0 ,day 1 day 15 day 30 ,day 60 and day 90. <br/ ><br>3. Complete Blood Count- day 0 ,day 15 ,day 30, day 60, day 90 <br/ ><br>4. Liver Function Test - day 0 ,day 15 ,day 30, day 60, day 90 <br/ ><br>5. Renal Function Test - day 0 ,day 15 ,day 30, day 60, day 90 <br/ ><br>;Chemokines and CytokinesTimepoint: Day o and Day 90;Circulating tumour cellsTimepoint: Day 0 and Day 90