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CTRI Number  CTRI/2023/07/055657 [Registered on: 25/07/2023] Trial Registered Prospectively
Last Modified On: 31/01/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Complementary cancer care using Ayurveda and integrative approaches : An observational study 
Scientific Title of Study   Outcomes of Ayurveda and Integrative Management of Cancer: An Observational, Descriptive study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrPrasan Shankar 
Designation  Medical Director 
Affiliation  Institute of Ayurveda and Integrative Medicine 
Address  Institute of Ayurveda and Integrative Medicine Rasayana Tantra Room number C-10
Rasayana Tantra Room number C-10
Bangalore
KARNATAKA
560064
India 
Phone  9945426118  
Fax    
Email  prasan.shankar@iaimhealthcare.org  
 
Details of Contact Person
Scientific Query  
Name  DrPrasan Shankar 
Designation  Medical Director 
Affiliation  Institute of Ayurveda and Integrative Medicine 
Address  Department of Rasayana Tantra, Ground floor ,room C 10

Bangalore
KARNATAKA
560064
India 
Phone  9945426118  
Fax    
Email  prasan.shankar@iaimhealthcare.org  
 
Details of Contact Person
Public Query  
Name  DrPrasan Shankar 
Designation  Medical Director 
Affiliation  Institute of Ayurveda and Integrative Medicine 
Address  Department of rasayna tantra, Ground floor ,Room C10

Bangalore
KARNATAKA
560064
India 
Phone  9945426118  
Fax    
Email  prasan.shankar@iaimhealthcare.org  
 
Source of Monetary or Material Support  
Rural India Support Trust Institute of Ayurveda and Integrative Medicine 
 
Primary Sponsor  
Name  RISt- Rural India Supporting Trust 
Address  RIST Office Address – 127 West 30th Street, Suite 1047, New York, NY 10001 Phone – (732) 824-4183 (Direct Line for Managing Director) E-Mail - shwetarawat@ristrust.org 
Type of Sponsor  Other [Trust] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrPrasan Shankar  Institute of Ayurveda and Integrative Medicine   Rasayana Tantra department ,Ground floor , Room C 10
Bangalore
KARNATAKA 		 9945426118

prasan.shankar@iaimhealthcare.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TDU IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:C00-D49||Neoplasms. Ayurveda Condition: ARBUDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All cancer patients visiting Rasayana tantra unit at I-AIM 
 
ExclusionCriteria 
Details  Patients unable to provide data due to any reasons (like giving additional time for data collection or due to altered mental status) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Quality of life measurements using EORTC-QLQ-c30, ECOG, VAS
• Patient-reported outcomes
 		 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
• Conduct basic blood biochemistry (Hb%, CBC, LFT, RFT, FBS, PPBS, HbA1c, urine routine) to ensure the safety of Ayurveda interventions along with inflammatory markers like CRP, D-dimer & albumin.
• Disease-specific cancer markers and RECIST 1.1 to assess progression wherever necessary
 		 1 year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)
Modification(s)  		 01/08/2023 
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="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prasan.shankar@iaimhealthcare.org].

  6. For how long will this data be available start date provided 03-10-2027 and end date provided 03-10-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Background
In India, cancer accounts for 9% of all deaths and the number of cases reported for the year 2020 was 1,392,179.
From the recent 2022 reports of ICMR-NCDIR-NCRP data, it is observed that there is a steep 2-fold rise in the cancer burden in India with a projected alarming rise by 12% between 2020 – 2025.
There is a need for Observational and real world data on the utility of Ayurveda in cancer care alongside deeper mechanistic studies
  AIM:
Systematic documentation and evaluation of outcomes of cancer patients volunteering at an Ayurveda hospital
  OBJECTIVES:
•    Measuring quality of life changes in cancer patients using globally accepted tools of measurement.
•    Measuring progression rate of solid tumours
•    Analysing Health seeking behaviour of Cancer patients.
•    To evaluate the outcomes of cancer management at I-AIM through retrospective data analysis


 
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