| CTRI Number |
CTRI/2021/10/037041 [Registered on: 01/10/2021] Trial Registered Prospectively |
| Last Modified On: |
30/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to evaluate relation between side effects of first line
chemotherapy in breast cancer patients with Prakruti. |
|
Scientific Title of Study
|
An observational survey study to evaluate relation between side effects of first line
chemotherapy in breast cancer patients with Prakruti. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSagar Bangar |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College of Ayurved and Research Centre |
| Address |
11/85 CCI Colony, MG Road, Goregaon West, Mumbai
Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Mumbai (Suburban)
MAHARASHTRA
400104
India |
| Phone |
9022721989 |
| Fax |
|
| Email |
sagar.bangar281993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Chaudhari |
| Designation |
Assistant professor |
| Affiliation |
PDEAS College of Ayurved and Research Centre |
| Address |
College of Ayurved and Research Centre, Akurdi, Pune
Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9975587176 |
| Fax |
|
| Email |
swati13mahajan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSagar Bangar |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College of Ayurved and Research Centre |
| Address |
11/85 CCI Colony, MG Road, Goregaon West, Mumbai
Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Mumbai (Suburban)
MAHARASHTRA
400104
India |
| Phone |
9022721989 |
| Fax |
|
| Email |
sagar.bangar281993@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Ayurved and Research Center,Nigdi, Pune 411044 |
|
|
Primary Sponsor
|
| Name |
College of Ayurved and Research Centre Akurdi Pune |
| Address |
Sector 25,Nigdi, Pune 400104 |
| Type of Sponsor |
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 |
| Sagar Bangar |
Ayurved Rugnalaya and Sterling Multispeciality Hospital |
Vitthal Rakhumai Rd, Sector No. 27, Ground Floor, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Pune
MAHARASHTRA |
9022721989
sagar.bangar281993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified. Ayurveda Condition: Breast Cancer, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Breast cancer patients receiving Chemotherapy. |
|
| ExclusionCriteria |
| Details |
Breast cancer patients receiving Chemotherapy but in very critical condition. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Conclusion will be strictly based on statistical analysis |
Every 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Which prakruti has more side effects of first line of chemotherapy in breast cancer. |
Every 6 months |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
11/10/2021 |
| 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="1"
Months="0"
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)?
Response - NO
|
|
Brief Summary
|
The prevalence rate of breast cancer has increased because of entry of carcinogenic substances through food or inhalation. Secondly lower immunity due to faulty lifestyle is also the cause of breast cancer. India has a breast cancer mortality rate of 12.7% per 100,000 women.4 In this context, Ayurvedic Prakruti Examination may prove to be useful, if the doctor knows which type Prakruti is more prone for side effects of Chemotherapy, then preventive measures can be taken as per Prakruti of a patient. Thus present research will be a boon both for patient and the doctor.
|