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CTRI Number  CTRI/2011/091/000187 [Registered on: 04/03/2011]
Last Modified On: 02/01/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study
Modification(s)  
Study to determine the response of Curcumin and Ashwagandha in high grade osteosarcoma 
Scientific Title of Study
Modification(s)  
Evaluation of curcumin-piperine, and Ashwagandha root powder in the management of advanced high grade osteosarcoma 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
381  Protocol Number 
NCT00689195  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Ajay Puri 
Designation  Professor and Head of Surgical Oncology  
Affiliation  Tata Memorial Hospital  
Address  Room No. 93, Bone & Soft Tissue Department, Ground Floor, Main Building
Tata Memorial Hospital, Dr E Borges Marg, Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177000  
Fax  022-24146937  
Email  docpuri@gmail.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Ashish Gulia 
Designation  Assistant Professor Orthopaedic Oncology  
Affiliation  Tata Memorial Hospital 
Address  Room No. 93, Bone & Soft Tissue Department, Ground floor, Main building
Tata Memorial Hospital Dr E Borges Marg, Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177000  
Fax  022-24146937  
Email  aashishgulia@gmail.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr Ashish Gulia 
Designation  Assistant Professor Orthopaedic Oncology  
Affiliation  Tata Memorial Hospital 
Address  Room No. 93, Bone & Soft Tissue Department, Ground floor, Main building
Tata Memorial Hospital Dr E Borges Marg, Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177000  
Fax  022-24146937  
Email  aashishgulia@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Intra Mural Funding Tata Memorial Hospital, Pharmanza Herbals Pvt. Limited (PHPL)  
 
Primary Sponsor
Modification(s)  
Name  Tata Memorial Hospital 
Address  Dr. E Borges Road, Parel, Mumbai-400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment
Modification(s)  
  India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajay Puri  Tata Memorial Hospital  Room No. 93, Bone & Soft Tissue Department, Ground floor, Main Building, Dr E Borges Marg, Parel 400012
Mumbai
MAHARASHTRA 
022-4177000

docpuri@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee-IRB, Tata Memorial Hospital, Parel, Mumbai 400012  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Advanced high grade Osteosarcoma of bone (extremities)  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Aswagandha Group(group I)  400mg capsule of alcoholic extract containing 4.5% concentration of Withaferrin A. Cohort 1 : 2 capsules twice a day Cohort 2: 3 capsules twice a day Cohort 3 : 4 capsules twice a day Cohort 4: 4 capsules three times a day 16 Blood Samples of 5 ml each  
Intervention  Curcummin group(group II)  A curcumin powder formulation with lecithin and stearic acid which protects it from converting to glucuronate in GI tract manufactured by Pharmanza herbal Pvt. Ltd, Gujrat will be used. Cohort 1 : 2g curcumin twice a day Cohort 2: 3g curcumin twice a day Cohort 3 : 4g curcumin twice a day Cohort 4 : 4g curcumin thrice a day 16 Blood Samples of 5 ml each  
 
Inclusion Criteria
Modification(s)  
Age From  8.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.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.
2.Patients with advanced disease unable or unwilling to take primary conventional treatment
3.Patients with early or non-metastatic disease who are unable or unwilling to take the standard chemotherapy.
4.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)
5.Adequate renal function defined by the creatinine clearance greater than 50 ml/min, calculated by Cockcroft-Gault formula
 
 
ExclusionCriteria 
Details  1.Patients who are suitable for second line chemotherapy and can afford it 2.Age less than 8 years or greater than 65 years 3.Pregnant or lactating women 4.Patients who are unable or unwilling to provide blood samples for the drug assays. 5.Low grade osteosarcoma 6.Participation in any investigational drug study within 28 days prior to study treatment.  
 
Method of Generating Random Sequence
Modification(s)  
Not Applicable 
Method of Concealment
Modification(s)  
Not Applicable 
Blinding/Masking
Modification(s)  
Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
In Vitro
1.To get formulation of curcumin & Ashwagandha prepared
2.To establish indigenous cell lines for osteosarcoma for future lab studies (studying the combination of curcumin & Ashwagandha

In Vivo-in human patients with advanced metastatic osteosarcoma who have exhausted their treatment options
3.To study the pharmacokinetics of curcumin & Ashwagandha
4.To establish a dose requirement for curcumin-piperine & Ashwagandha
5.To test the efficacy & safety of curcumin & Ashwagandha  
4 years 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size
Modification(s)  
Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial
Modification(s)  
Phase 1/ Phase 2 
Date of First Enrollment (India)
Modification(s)  
05/08/2008 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  
Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Safety and pharmacokinetics of a solid lipid curcumin particle formulation in osteosarcoma patients and healthy volunteers. Gota VS, Maru GB, Soni TG, Gandhi TR, Kochar N, Agarwal MG. J Agric Food Chem. 2010 Feb 24;58(4):2095-9. doi: 10.1021/jf9024807 
Brief Summary
Modification(s)  
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 is Non-Randomized Parallel group study.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 In both groups, the tablets will be given daily for 3 months if well tolerated. A CT chest and local x-rays will be done at 3 months and response will be assessed. If the response is good and there is no Dose limiting Toxicity (DLT), the medication will be continued for another 3 months. 
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