| CTRI Number |
CTRI/2025/07/090180 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Investigating the Causes of Breast Cancer in Women with the perspective of Ayurveda |
|
Scientific Title of Study
|
A case control study to evaluate the association of etiological factors in females with breast carcinoma with special reference to rasavaha and shukravaha srotodushti |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrunal Shirsikar |
| Designation |
PG student |
| Affiliation |
Dr D Y Patil college of ayurved and research centre pimpri pune |
| Address |
Department of Samhita Siddhant fourth floor Dr D Y Patil college of ayurveda and research center pimpri pune 18
Bhosari MIDC Pimpri Pune- 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9822086750 |
| Fax |
|
| Email |
mrunalshirsikarms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shital R Rasane |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil college of ayurved and research centre Pimpri Pune |
| Address |
Department of samhita siddhant fourth floor Dr D Y Patil college of Ayurved and research centre Pimpri Pune
Bhosari MIDC Pimpri Pune- 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9503330831 |
| Fax |
|
| Email |
shitalrasane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrunal Shirsikar |
| Designation |
PG student |
| Affiliation |
Dr D Y Patil college of ayurved and research centre Pimpri Pune |
| Address |
department of samhita siddhant fourth floor Dr D Y patil college of ayurved and research center pimpri pune
Bhosari MIDC Pimpri Pune- 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9822086750 |
| Fax |
|
| Email |
mrunalshirsikarms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil college of Ayurved and Research centre Pimpri Pune 411018 |
|
|
Primary Sponsor
|
| Name |
Mrunal Shirsikar |
| Address |
4B Shree, Gautam nagar, near Ramdevbaba mandir, Shelgi Solapur- 413006 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mrunal Shirsikar |
Indrayani hospital and cancer institute |
OPD, Alandi Chakan road, Alandi devachi Charholi budruk Pune 412105
Pune
MAHARASHTRA |
9822086750
mrunalshirsikarms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr DYPCA & RC Instititional 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 | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:NIL, Pathya/Apathya:, Pathya:, Apathya: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:NIL, Pathya/Apathya:, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Case group-
Females between age 20-80 years of age pre-diagnosed with Breast
Carcinoma, irrespective of the grade of carcinoma
Control group-
Females between the age 20-80 years, who have not been
diagnosed with any type of CA |
|
| ExclusionCriteria |
| Details |
Case group-
Females diagnosed with all other types of Carcinoma.
Control group-
Females who have been diagnosed with any benign conditions of breast. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between the etiological factors of Rasavaha and shukravaha srotodushti with breast carcinoma in females already diagnosed with breast CA |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| association of rajovaha srotas dushti in breast carcinoma |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2025 |
| Date of Study Completion (India) |
02/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
1. Selection of patients according to the inclusion and exclusion criteria in the case and control groups. 2. questionnaire- interview based. 3. Noting the observations 4. Application of appropriate statistical tests. 5. result |