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Note: This record shows only 22 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: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2008/091/000052
Date of registration: 30-04-2008
Prospective Registration: Yes
Primary sponsor: Council of Scientific & Industrial Research, New Delhi
Public title: 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: 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
Date of first enrolment: 01-05-2008
Target sample size: 60
Recruitment status: Not Yet Recruiting
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=93
Study type:  Interventional
Study design:  Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
 
Phase:  Phase 2
Countries of recruitment
India
Contacts
Name: Dr. Urmila Thatte   
Address:  Professor & Head, Dept. of Clinical Pharmacology TNMC & BYL Nair Hospital, Mumbai Central, 400 008 Mumbai, MAHARASHTRA India
Telephone: 022-23014713, 23050347
Email: urmilathatte@gmail.com
Affiliation:  Professor & Head, Dept. of Clinical Pharmacology
Name: Dr. Shilpa Gaikwad   
Address:  Study Coordinator, TNMC & BYL Nair Hospital, Mumbai Central 400 008 Mumbai, MAHARASHTRA India
Telephone: 022-23014713, 23050347
Email: urmilathatte@gmail.com
Affiliation:  Professor & Head, Dept. of Clinical Pharmacology
Key inclusion & exclusion criteria
Inclusion criteria: 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

Exclusion criteria: 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


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Intervention(s)
Intervention1: Tablet PHP-Cancer containing hydro-alcoholic extracts of Withania somnifera 150mg and Tinospora cordifolia 200 mg: 500 mg BD for 6 months
Control Intervention1: Tablet Placebo: 500 mg BD for 6 months
Primary Outcome(s)
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.Timepoint:
Secondary Outcome(s)
Not ApplicableTimepoint:
Secondary ID(s)
PHP/CSIR/2006/3
Source(s) of Monetary Support
Council of Scientific & Industrial Research, New Delhi
Secondary Sponsor(s)
Indian Institute of Integrative Medicine, Jammu
Ethics review
Status: Approved
Approval date:
Contact:
Ethics Committee for Research on Human Subjects, Seth G.S.Medical College & K.E.M. Hospital, Parel, Mumbai -400 012.
Status: Approved
Approval date:
Contact:
Ethics Committee of Vydehi Hospital (ECVH),EPIP area, Whitefield, Bangalore-560 006
Status: Approved
Approval date:
Contact:
Ethics Committee, B.Y.L.Nair Charitable Hospital & T.N. Medical College,2nd Floor, College Bldg, Mumbai Central, Mumbai-400 008
Results
Results available:
Date Posted:
Date Completed:
URL:
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