| CTRI Number |
CTRI/2024/02/062759 [Registered on: 16/02/2024] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to identify dietary and lifestyle causes according to ayurved in the patients of Cancer |
|
Scientific Title of Study
|
A cross-sectional study to identify the risk factors from Aaharaja and Viharaja hetu of
Mansavaha Srotas Dushti in the patients of Malignancy. |
| 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 Ganesh Ramesh Rode |
| Designation |
P.G. Student |
| Affiliation |
PDEAs college of ayurveda and research center |
| Address |
PDEAs college of ayurveda and research center,2nd
floor,Swasthavritta and yoga department,sector no.25 pradhikaran,
nigdi,pune 411044
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
8308605216 |
| Fax |
|
| Email |
ganeshrode555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajkumar Bobade |
| Designation |
Professor and HOD |
| Affiliation |
PDEAs college of ayurveda and research center |
| Address |
PDEAs college of ayurveda and research center,2nd
floor,Swasthavritta and yoga department,sector no.25 pradhikaran,
nigdi,pune 411044
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9403928005 |
| Fax |
|
| Email |
rajkumarbobade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Ramesh Rode |
| Designation |
P.G. Student |
| Affiliation |
PDEAs college of ayurveda and research center |
| Address |
PDEAs college of ayurveda and research center,2nd
floor,Swasthavritta and yoga department,sector no.25 pradhikaran,
nigdi,pune 411044
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
8308605216 |
| Fax |
|
| Email |
ganeshrode555@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurved and research center nigdi pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurved and reserach center |
| Address |
sector no.25 pradhikaran nigdi pune 411044
|
| 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 |
| Dr Ganesh Rode |
PDEAs College of Ayurved and Research Centre |
Department of
Swasthavritta, Room
No 123B, PDEAs
College of Ayurved and
Research Centre,
Sector No 25, Nigdi,
Pune 411044
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8308605216
ganeshrode555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D498||Neoplasm of unspecified behavior of other specified sites. Ayurveda Condition: MAMSAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:NIL, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patient having malignant tumor |
|
| ExclusionCriteria |
| Details |
cancer of the blood-leukemia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify risk factors from aharaja and viharaja hetu of mansavaha srotas dushti in patients of malignancy |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
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)
|
26/02/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
| Cancer, a disease resulting from deregulated cell growth control and caused by an interaction of dietary, genetic and environmental risk factor. In modern science lot of work has been done on dietary risk factors of cancer. Ayurvedic principles like Aahara (food), Vihara (daily regimen), srotas (body channels) are much unique and eternal concepts. Srotas is one of most important functioning system in body. Dushti of Mansawaha srotas leads to various diseases. Cancer (arbuda) is most serious among them. When it comes to ayurvedic chikitsa perspective, nidana parivarjana plays very important role, So to identify the risk factors from Aaharaja and Viharaja hetu of mansawaha srotas dushti in the patients of malignancy this topic is selected. | |