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A study of Ayurvedic Arsenic compound (Somal) in treatment of solid tumors.

A prospective, open label, pilot, study to evaluate efficacy, safety and bio- availability of oral Arsenic compound prepared by Ayurvedic method (Somal- NTAX-44) in patients with solid tumours.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013086
Enrollment
30
Registered
2018-04-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Arsenic Trioxide: A Prospective, open labelled,pilot,study to evaluate safety,efficacy and bioavailability of oral Arsenic Trioxide prepared by Ayurveda method (Somal) in five different

Sponsors

Rasayani Biologics Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1.Pet scan /CT Scan /MRI Scan at baseline (Day 0) and post interventional (Day 90) 2. Quality of life assessment using validated questionnairesâ?? at baseline and 15 days intervals (FACT-G). 3. ECOG Performance status after every 15 days. Timepoint: 1.Pet scan /CT Scan /MRI Scan at baseline (Day 0) and post interventional (Day 90) 2. Quality of life assessment using validated questionnairesâ?? at baseline and 15 days intervals (FACT-G). 3. ECOG Performance status after every 15 days.—

Secondary

MeasureTime frame
1. Whole Blood For Arsenic Concentration 2. Electrocardiograph. 3. Complete Blood Count 4. Liver Function Test 5. Renal Function Test Timepoint: 1. Detection of Arsenic concentration in blood Day,30,60 and 90. 2. Effect on heart â??Electrocardiograph will be done on day 0 ,day 1 day 15 day 30 ,day 60 and day 90. 3. Complete Blood Count- day 0 ,day 15 ,day 30, day 60, day 90 4. Liver Function Test - day 0 ,day 15 ,day 30, day 60, day 90 5. Renal Function Test - day 0 ,day 15 ,day 30, day 60, day 90 ;Chemokines and CytokinesTimepoint: Day o and Day 90;Circulating tumour cellsTimepoint: Day 0 and Day 90—

Countries

India

Contacts

Public ContactDr Santosh Patil

KLE Universityâ??s BMK Ayurveda Hospital and Research Center, Shahapur, Belgaum

dr.santosh19@gmail.com08312486286

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026