| CTRI Number |
CTRI/2008/091/000052 [Registered on: 30/04/2008] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| 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 |
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Scientific Title of Study
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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 |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| PHP/CSIR/2006/3 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| 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 |
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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 |
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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 |
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Source of Monetary or Material Support
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| Council of Scientific & Industrial Research, New Delhi |
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Primary Sponsor
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| Name |
Council of Scientific & Industrial Research, New Delhi |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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| Name |
Address |
| Indian Institute of Integrative Medicine, Jammu |
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Countries of Recruitment
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India |
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Sites of Study
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| 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 |
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Details of Ethics Committee
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| 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 |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Breast cancer receiving chemotherapy , |
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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 |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| 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
|
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| 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
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Pre-numbered or coded identical Containers |
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Blinding/Masking
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
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| 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. |
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Secondary Outcome
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| Outcome |
TimePoints |
| Not Applicable |
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Target Sample Size
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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" |
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Phase of Trial
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Phase 2 |
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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 |
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Estimated Duration of Trial
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Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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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. |