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CTRI Number  CTRI/2008/091/000052 [Registered on: 30/04/2008]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effects of Ayurvedic formulation containing Ashwagandha and Guduchi in improving the quality of life in patients of breast cancer receiving chemotherapy as treatment  
Scientific Title of Study   A Proof of Concept prospective, double-blind, placebo-controlled, randomized clinical trial to assess the effects of PHP- Cancer in improving quality of life in patients receiving chemotherapy for treatment of breast cancer 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PHP/CSIR/2006/3  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Urmila Thatte 
Designation   
Affiliation   
Address  Professor & Head, Dept. of Clinical Pharmacology
TNMC & BYL Nair Hospital, Mumbai Central,
Mumbai
MAHARASHTRA
400 008
India 
Phone  022-23014713, 23050347  
Fax  022-23050347  
Email  urmilathatte@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Urmila Thatte 
Designation   
Affiliation  Professor & Head, Dept. of Clinical Pharmacology 
Address  Professor & Head, Dept. of Clinical Pharmacology
TNMC & BYL Nair Hospital, Mumbai Central,
Mumbai
MAHARASHTRA
400 008
India 
Phone  022-23014713, 23050347  
Fax  022-23050347  
Email  urmilathatte@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Shilpa Gaikwad 
Designation   
Affiliation   
Address  Study Coordinator,
TNMC & BYL Nair Hospital, Mumbai Central
Mumbai
MAHARASHTRA
400 008
India 
Phone  022-23014713  
Fax  022-23050347  
Email  csir.phpproject@gmail.com  
 
Source of Monetary or Material Support  
Council of Scientific & Industrial Research, New Delhi 
 
Primary Sponsor  
Name  Council of Scientific & Industrial Research, New Delhi  
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
Indian Institute of Integrative Medicine, Jammu   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. NN Rege  Seth G.S. Medical College & KEM Hospital, Parel, Mumbai 400 012  Associate Professor, Dept. of Pharmacology & Therapeutics,Seth G.S. Medical College & KEM Hospital, Parel,-400 012
Mumbai
MAHARASHTRA 
22-24181744
022-24121711
kemarc@vsnl.com 
Dr. Urmila Thatte  TNMC & BYL Nair Hospital, Mumbai Central, Mumbai 400 008  Professor & Head, Dept. of Clinical Pharmacology,TNMC & BYL Nair Hospital, Mumbai Central,-400 008
Mumbai
MAHARASHTRA 
022-23014713, 23050347
022-23050347
urmilathatte@gmail.com 
Dr. D.Palaniyamma  Vydehi Institute of Medical Science and Research Centre, 82, EPIP area, Whitefield. Bangalore-560 00  Study co-ordinator, Dept. of Pharmacology,Vydehi Institute of Medical Science and Research Centre, 82, EPIP area, Whitefield.-560 006
Bangalore
KARNATAKA 
080-41157443
080-41157442
palani@clintracintl.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics Committee for Research on Human Subjects, Seth G.S.Medical College & K.E.M. Hospital, Parel, Mumbai -400 012.  Approved 
Ethics Committee of Vydehi Hospital (ECVH),EPIP area, Whitefield, Bangalore-560 006  Approved 
Ethics Committee, B.Y.L.Nair Charitable Hospital & T.N. Medical College,2nd Floor, College Bldg, Mumbai Central, Mumbai-400 008  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Breast cancer receiving chemotherapy ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tablet PHP-Cancer containing hydro-alcoholic extracts of Withania somnifera 150mg and Tinospora cordifolia 200 mg  500 mg BD for 6 months 
Comparator Agent  Tablet Placebo  500 mg BD for 6 months 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1. Female patients in age group of 18 to 60 years (irrespective of menopausal status) with a life expectancy of at least 6 months 2. Patients with breast cancer scheduled to receive chemotherapy 3. Patients ready to consent and to abide by trial related procedures  
 
ExclusionCriteria 
Details  1. Patients likely to receive radiation therapy; alone or in combination with chemotherapy during the study period 2. Patients scheduled to receive palliative chemotherapy 3. Patients with mental condition that would interfere with completion of questionnaires 4. Patients receiving prophylactic G-CSF therapy 5. History of intake of ANY Ayurvedic/herbal/homeopathic/ dietary supplements (including Vitamin E) or any alternative therapies for the last one month. 6. Liver, kidney and/or bone marrow disorders 7. Acute medical/surgical complications which require hospitalization  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measures will be 20% improvement in the QOL score over and above that obtained in the group receiving placebo and less than 10% difference in adverse events (including laboratory variables) between placebo and active treatment groups.    
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable   
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/05/2008 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a Proof of Concept, prospective, double-blind, placebo-controlled, randomized clinical trial to assess the effects of PHP- Cancer i.e. a formulation containing Withania sominfera (hydro-alcoholic extract of root, 150 mg) and Tinospora cordifolia (hydro-alcoholic extract, 200mg) in comparison with Placebo (500 mg tablet containing starch) in the improving quality of life in patients receiving chemotherapy for treatment of breast cancer. PHP-Cancer formulation will be initiated at least three days prior to the first dose of chemotherapy and continued for 1 month after the last cycle. A total of at least 4 cycles of chemotherapy will be observed. Patients in whom further cycles of chemotherapy are planned will continue to receive PHP-Cancer/Placebo as described above and will be observed for a maximum duration of 6 cycles. Thus the drug will be administered twice day for maximum of 6months to 60 patients and the trial will be conducted in 3 centres in India. The primary outcome measures will be 20% improvement in the QOL score over and above that obtained in the group receiving placebo and less than 10% difference in adverse events (including laboratory variables) between placebo and active treatment groups.  
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