| CTRI Number |
CTRI/2025/09/094220 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of gene mutations(changes) with body constitution (Prakruti) and female reproductive system in breast cancer patients. |
|
Scientific Title of Study
|
Assessment of correlation of BRCA1 / BRCA2 mutation with Prakruti and Artava- vaha Srotas in breast cancer patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SAMEER NARAYAN GORE |
| Designation |
RESEARCH ASSOCIATE |
| Affiliation |
|
| Address |
BHARATIYA SANSKRITI DARSHAN TRUST WAGHOLI PUNE
Pune
MAHARASHTRA
412207
India |
| Phone |
9604975710 |
| Fax |
|
| Email |
drsngore@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineeta V Deshmukh |
| Designation |
Deputy Director |
| Affiliation |
Bharatiya Sanskriti Darshan Trusts Integrated Cancer Treatment and Research Centre |
| Address |
Bharatiya Sanskriti Darshan Trusts Panchakarma Hospital Building, Ground floor, Gat No 676, Kesnand Road, Wagholi, Pune - 412207
Bharatiya Sanskriti Darshan Trusts Integrated Cancer Treatment and Research Centre, , Ground floor, Gat No 676, Kesnand Road, Wagholi, Pune - 412207
Pune
MAHARASHTRA
412207
India |
| Phone |
919820648058 |
| Fax |
|
| Email |
ictrcpune@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoja A Joshi |
| Designation |
H.O.D of Ayurveda |
| Affiliation |
Tilak Maharashtra Vidyapeeth, Faculty of Ayurveda |
| Address |
Tilak Maharashtra Vidyapeeth, Faculty of Ayurveda
1st floor, Gultekdi, Pune
Pune
MAHARASHTRA
411037
India |
| Phone |
919168226879 |
| Fax |
|
| Email |
ayutmv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharatiya Sanskriti Darshan Trusts Integrated Cancer Treatment and Research Centre
Vishwashantidham, Gat no 676
Kesnand Road, Wagholi,
Pune - 412207, MS, India |
|
|
Primary Sponsor
|
| Name |
Bharatiya Sanskriti Darshan Trusts Integrated Cancer Treatment and Research Centre |
| Address |
Gat no 676, Kesnand Road, Wagholi, Pune - 412207, Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Manoja Joshi |
Tilak Maharashtra Vidyapeeth, Faculty of Ayurveda, 1st floor, Gultekdi, Pune - 411037 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sameer N Gore |
Bharatiya Sanskriti Darshan Trust |
Integrated Cancer Treatment and Research Centre, Room no 1
Gat no 676, Kesnand Road, Wagholi, Pune - 412207
Pune
MAHARASHTRA |
0206734600
drsngore@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharatiya Sanskriti Darshan Trust’s Ayurved Hospital Research and Development - Integrated Cancer Treatment and Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:C50||Malignant neoplasm of breast. Ayurveda Condition: ARBUDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Female breast cancer patients of stage I, II and III with and without BRCA 1 and BRCA 2 mutations |
|
| ExclusionCriteria |
| Details |
Female breast cancer patients of stage IV,
Multiple primary malignancies
Male breast cancer patients
Breast cancer patients having mutations other than BRCA 1 or BRCA 2 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.a Variation in body constitution in mutated and non mutated breast cancer patients wrt physiological, physical and mental aspects.
1.b Variation in female reproductive system wrt menstruation and parity |
Data regarding the Prakriti and Aartava-vaha Srotasa of the patients will be collected in the beginning of the study i.e. at baseline. This study being observational study, no specific timepoints are required. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison between components of mutation analysis such as gene transcript, location, variant, zygosity, etc with Prakruti |
This study being observational study, only baseline time point is required. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/10/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study is an observational study of female breast cancer patients who are tested for BRCA 1 and BRCA 2 mutations and their assessment will be done on the basis of their Prakriti and Aartavavaha Srotas (menstrual and obstetric history). The primary objective is to study the association between positive and negative BRCA 1 and BRCA 2 mutated breast cancer patients with their Prakriti and status of Aartavavaha Srotas. The secondary objective will include study of association between Prakriti and various components of mutation analysis like gene (transcript), location, variant, zygosity, etc.
|