| CTRI Number |
CTRI/2018/02/012113 [Registered on: 23/02/2018] Trial Registered Prospectively |
| Last Modified On: |
23/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of an ayurvedic treatment schedule in patients with breast cancer |
|
Scientific Title of Study
|
A pilot study on the effect of an ayurvedic treatment schedule on the protein profiles of breast cancer patients using High Performance Liquid Chromatography – Laser Induced Fluorescence (HPLC – LIF) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh PR |
| Designation |
Chief (Clinical Research) |
| Affiliation |
Vaidyaratnam P.S. Varier Arya Vaidya Sala, Kottakkal |
| Address |
Clinical research Department
Arya Vaidya Sala
Kottakkal
Malappuram district
Malappuram
KERALA
676503
India |
| Phone |
04832808195 |
| Fax |
|
| Email |
rameshvarier@aryavaidyasala.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh PR |
| Designation |
Chief (Clinical Research) |
| Affiliation |
Vaidyaratnam P.S. Varier Arya Vaidya Sala, Kottakkal |
| Address |
Clinical research Department
Arya Vaidya Sala
Kottakkal
Malappuram district
KERALA
676503
India |
| Phone |
04832808195 |
| Fax |
|
| Email |
rameshvarier@aryavaidyasala.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh PR |
| Designation |
Chief (Clinical Research) |
| Affiliation |
Vaidyaratnam P.S. Varier Arya Vaidya Sala, Kottakkal |
| Address |
Clinical research Department
Arya Vaidya Sala
Kottakkal
Malappuram district
KERALA
676503
India |
| Phone |
04832808195 |
| Fax |
|
| Email |
rameshvarier@aryavaidyasala.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam P.S. Varier Arya Vaidya Sala
Kottakkal P.O, Malappuram, Kerala, Pin:676503 |
|
|
Primary Sponsor
|
| Name |
The Managing Trustee |
| Address |
Vaidyaratnam P.S. Varier Arya Vaidya Sala
Kottakkal P.O, Malappuram, Kerala, Pin:676503 |
| Type of Sponsor |
Other [Charitable Institution ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| The Registrar |
Manipal Academy of Higher Education, Manipal, Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh PR |
Arya Vaidya Sala Charitable Hospital |
Speical OPD, Charitable Hosptial, Arya Vaidya Sala, Kottakkal
Malappuram
KERALA |
04832808195
rameshvarier@aryavaidyasala.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Arya Vaidya Sala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Breast Cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Healthy individuals |
No medications given.
2 ml venous blood collected for HPLC-LIF for evaluation. |
| Intervention |
Oral medications |
Medicines described in the classical texts of Ayurveda |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Newly diagnosed cases of breast cancer |
|
| ExclusionCriteria |
| Details |
1.Undergoing treatment for any other cancers other than breast cancer
2.Breast cancer cases post surgery, post radiotherapy and chemotherapy
3.Breast cancer cases with auto immune diseases.
4.Breast cancer cases with any other systemic diseases.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in Protein profiles of blood sample
2. Early diagnosis
|
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Quality of life |
2 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is an open clinical trial to study the effect of an ayurvedic treatment schedule on the protein profiles of breast cancer patients using High Performance Liquid Chromatography (HPLC-LIF ) and to compare the protein profiles of breast cancer patients and healthy volunteers using High Performance Liquid Chromatography- Laser Induced Fluorescence (HPLC-LIF). Two ml blood will be collected from each participant satisfying the eligibility criteria, before starting the treatment after getting the informed consent. The blood samples will be frozen and sent to the department of atomic and molecular physics, Manipal Institute of Technology for conducting the HPLC-LIF evaluation. The treatments are started for breast cancer patients as per the protocol. At the end of fourth and eighth week, blood samples are collected again and sent for evaluation. Two ml venous blood samples are collected from twenty healthy volunteers before the study and after eight weeks.The data obtained will be analyzed using appropriate statistical methods. |