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Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma

NCT00689195 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-06-23

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Curcumin powder

oral capsules containing the investigational agent

DIETARY_SUPPLEMENT

Ashwagandha extract

4.5% extract of ashwagandha

Sponsors & Collaborators

  • Pharmanza Herbals Pvt Limited (PHPL)

    collaborator UNKNOWN

  • Tata Memorial Hospital

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00689195 on ClinicalTrials.gov