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Safety and bioavailability of Somal in Cancer

A pilot study to evaluate systemic availablity of oral therapeutic agent somal (Arsenic Trioxide) in cancer patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/04/013072
Enrollment
30
Registered
2018-04-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Bioavalibility studty of Arsenic Trioxide in cancer patients

Interventions

Intervention1: Arsenic trioxide (ATO) is ananticancer drug treatment for the treatment of Acute Promyelocytic Leukaemia (APL).: Ayurveda Practitioners also use oral Arsenic Trioxide (Somal) in wide ra

Sponsors

Rasayani Cancer Clinics Pune
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. male or female cancer patient aged 20 to 70 years. 2.Cancer Patients who has expected survival of more than 3 months. 3.Cancer Patients who are not willing to take chemotherapy/eligible to take chemotherapy. 4.Cancer patients who are eligible to receive treatment of Somal. 5. Cancer patient who are willing to take ayurvedic treatment for cancer and provide consent for the same.

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 Patients who has ECOG performance is > 2

Design outcomes

Primary

MeasureTime frame
To study the bioavailability of Arsenic in patients consuming Somal.Timepoint: Day0, Day30, Day60, and Day90.

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactDr Poonam Birari

Rasayu Cancer Clinic Pune.

poonam.birari84@gmail.com02024537149

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026