| CTRI Number |
CTRI/2025/12/099971 [Registered on: 31/12/2025] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Conceptual study |
| Study Design |
Other |
|
Public Title of Study
|
Ayurvedic assessment of type of breast cancer in woman. |
|
Scientific Title of Study
|
Study of Ayurvedic diagnosis of breast cancer as Anukta vyadhi . |
| 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 Nandita S Joshi |
| Designation |
PhD scholar |
| Affiliation |
B. S.D.T. Integrated Cancer Treatment and Research Centre and B.S.D.T Ayurveda mahavidyalaya . |
| Address |
B.S.D.T.Integrated Cancer Treatment and Research Centre and B.S.D.T Ayurveda mahavidyalaya .
Gat No 676, Kesnand Road, Wagholi, Pune- 412207, Maharashtra, India
Pune
MAHARASHTRA
412207
India |
| Phone |
9892363692 |
| Fax |
|
| Email |
nandiasjoshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineeta V. Deshmukh |
| Designation |
PhD guide |
| Affiliation |
B. S.D.T. Integrated Cancer Treatment and Research Centre and B.S.D.T Ayurveda mahavidyalaya . |
| Address |
B.S.D.T.Integrated Cancer Treatment and Research Centre and B.S.D.T Ayurveda mahavidyalaya .
Gat No 676, Kesnand Road, Wagholi, Pune- 412207, Maharashtra, India
Pune
MAHARASHTRA
412207
India |
| Phone |
9820648058 |
| Fax |
|
| Email |
vineeta_deshmukh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandita S Joshi |
| Designation |
PhD scholar |
| Affiliation |
B. S.D.T. Integrated Cancer Treatment and Research Centre and B.S.D.T Ayurveda mahavidyalaya . |
| Address |
B.S.D.T.Integrated Cancer Treatment and Research Centre and B.S.D.T Ayurveda mahavidyalaya .
Gat No 676, Kesnand Road, Wagholi, Pune- 412207, Maharashtra, India
Pune
MAHARASHTRA
412207
India |
| Phone |
9892363692 |
| Fax |
|
| Email |
nandiasjoshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| - B.S.D.T.Integrated Cancer Treatment and Research Centre .
Gat No 676, Kesnand Road, Wagholi, Pune,
Maharashtra, India,
PIN CODE- 412207,
|
|
|
Primary Sponsor
|
| Name |
B.S.D.T.Integrated Cancer Treatment and Research Centre and Ayurveda mahavidyalaya. Wagholi, Pune |
| Address |
Gat No 676, Kesnand Road, Wagholi, Pune- 412207, Maharashtra, India |
| Type of Sponsor |
Other [Research institution hospital and private medical college ] |
|
|
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 Nandita SJoshi PI |
B.S.D.T’s I.C.T.R.C. And Ayurveda Hospital and research center. |
Ground floor, Female Surgical Ward and Operation Theatre. Gat No 676, Kesnand Road, Wagholi, Pune, Maharashtra, India, Pin code -- 412207
Pune
MAHARASHTRA |
989236362
nanditasjoshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of BSDT I.C.T.R.C Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:C509||Malignant neoplasm of breast of unspecified site. Ayurveda Condition: ARBUDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.Subjects voluntarily participating in study with informed consent.
2.Participants suffering from breast cancer undergoing BCT- Breast Conservative Surgery or Simple Mastectomy or MRM -Modified Radical Mastectomy.
|
|
| ExclusionCriteria |
| Details |
•Patients diagnosed with Breast carcinoma who have been advised Neo Adjuvant Chemotherapy.
•Male patients suffering from breast cancer.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome will be diagnosing the breast cancer by applying Ayurvedic principals.
On the day of surgery, the excised tumor will be assessed as per textual reference as follows- Akruti (Size), Swaroopa (Appearance), Varna (Colour), Gandha (Smell), Strava (Secretions) and Sparsha (Touch). The sample will be taken as it is (without putting it into formalin as to avoid the effect of formalin on the sample appearance ), where the
cut section will be taken and the details of the cut section will be noted again. Correlation of Hetu (causes) and dosh dushya pradhanya, based on the assessment of excised Breast tumor specimen, HPR (histopathology report), and Radiological findings (MRI Breast, Mammography, CT scan) will be studied and noted down. |
two years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcome will be establishing the correlation of hetu (causative factors like Diet, lifestyle, addiction, psychological risk factors) and Rupa (signs and symptoms) of breast cancer.
This will be done by taking detailed case history including diet and lifestyle, psychological factors, and other causes will be taken. Then the diagnosis of Breast cancer will be done applying Ayurvedic principles for examination of tumour and patient.
|
2 years |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ictrcmumbai@gmail.com].
- For how long will this data be available start date provided 01-07-2028 and end date provided 30-06-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is an Observational and conceptual, study
of ayurvedic diagnosis of breast cancer as anukta vyadhi . In this study
the primary objective is to diagnose
breast cancer by applying Ayurvedic principals.
On the day of surgery, the
excised tumor will be assessed as per textual reference as follows- Akruti
(Size), Swaroopa (Appearance), Varna (Colour),
Gandha (Smell), Strava (Secretions) and Sparsha (Touch).
The sample will be taken as it is (without putting it into formalin as to avoid
the effect of formalin on the sample appearance ), where the cut section will
be taken and the details of the cut section will be noted again. Correlation of
Hetu (causes) and dosh dushya pradhanya, based on the assessment
of excised Breast tumor specimen, HPR (histopathology report), and Radiological
findings (MRI Breast, Mammography, CT scan) will be studied and noted down.
The secondary objective is to
correlate hetu (causative factors like Diet, lifestyle, addiction,
psychological risk factors) and Rupa (signs and symptoms) of
breast cancer. This will be
done by taking detailed case history including diet and lifestyle,
psychological factors, and other causes will be taken. Then the diagnosis of
Breast cancer will be done applying Ayurvedic principles for examination of
tumour and patient.
This method
will be beneficial to treat breast cancer patient from Ayurvedic perspective
with precision in future.
|