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Clinical Trial Summary

Curcumin as well as the ashwagandha extract are ingredients from traditional indian medicine and have been shown to be potent anti-cancer compounds in laboratory as well as animal studies. This study will test the safety and efficacy of a curcumin formulation and the ashwagandha extract in high grade relapsed or metastatic osteosarcoma where no other second line chemotherapy is being given. The pharmacokinetics will be studied along with response as measured on CT scans and PET scans as well as the quality of life and any toxicity.


Clinical Trial Description

Eligibility criteria

1. Osteosarcoma which has relapsed after treatment and for which no second line chemotherapy is planned and in which disease is not amenable to surgery.

2. Patient should be able to follow-up 3 monthly for clinical and imaging assessment as well as biochemical tests ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00689195
Study type Interventional
Source Tata Memorial Hospital
Contact Manish Agarwal, M.S(Orth), D.N.B(Orth)
Phone 91-22-2444-7189
Email mgagarwal@gmail.com
Status Recruiting
Phase Phase 1/Phase 2
Start date May 2008
Completion date June 2013

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