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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00689195
Date of registration: 23/05/2008
Primary sponsor: Tata Memorial Hospital
Public title: Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma OSCAT
Scientific title: Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma"
Date of first enrolment: May 2008
Target sample size: 24
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00689195
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients (between the ages of 8 to 65 years) with histologically proven high grade
osteosarcoma of the extremity and relapsed disease after primary line of treatment
who are unsuitable or refuse secondary chemotherapy.

- Patients with advanced disease unable or unwilling to take primary conventional
treatment

- Patients with early or non-metastatic disease who are unable or unwilling to take the
standard chemotherapy.

- Adequate hepatic function defined by total bilirubin not more than 1.5 times the
upper limit of normal (ULN) and SGOT and SGPT not more than 2.5 times the (ULN)

- Adequate renal function defined by the creatinine clearance greater than 50 ml/min,
calculated by cockcroft-Gault formula

Exclusion Criteria:

- Patients who are suitable for second line chemotherapy and can afford it

- Age less than 8 years or greater than 65 years

- Pregnant or lactating women

- Patients who are unable or unwilling to provide blood samples for the drug assays.

- Low grade osteosarcoma

- Patient requiring treatment with CYP3A4 inducers or inhibitors (patients on treatment
for epilepsy or tuberculosis)

- Participation in any investigational drug study within 28 days prior to study
treatment.



Age minimum: 8 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Osteosarcoma
Intervention(s)
Dietary Supplement: Ashwagandha extract
Dietary Supplement: Curcumin powder
Primary Outcome(s)
response, toxicity, disease progression [Time Frame: 2 years]
Secondary Outcome(s)
quality of life [Time Frame: 2 years]
Secondary ID(s)
381
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Pharmanza Herbals Pvt Limited (PHPL)
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