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CTRI Number  CTRI/2024/06/068682 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 03/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To assess the efficacy of oral cannabis extract for pain management in cancer patients undergoing cancer directed treatment 
Scientific Title of Study   Pilot Study to assess the efficacy of cannabinoid-rich Oral cannabis extract for pain management in cancer patients undergoing cancer directed treatment (surgery, systemic therapy, radiation therapy)and who have received systemic analgesics 
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 Manish Singhal 
Designation  Senior Consultant Medical Oncologist 
Affiliation  Indraprastha Apollo Hospitals New Delhi 
Address  Indraprastha Apollo Hospitals Medical Oncology Department Room No 11 Sarita Vihar Delhi Mathura Road New Delhi 110076

New Delhi
DELHI
110076
India 
Phone  9818521155  
Fax    
Email  singhaloncocare@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Manish Singhal 
Designation  Senior Consultant Medical Oncologist 
Affiliation  Indraprastha Apollo Hospitals New Delhi 
Address  Indraprastha Apollo Hospitals Medical Oncology Department Room No 11 Sarita Vihar Delhi Mathura Road New Delhi 110076

New Delhi
DELHI
110076
India 
Phone  9818521155  
Fax    
Email  singhaloncocare@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Manish Singhal 
Designation  Senior Consultant Medical Oncologist 
Affiliation  Indraprastha Apollo Hospitals New Delhi 
Address  Indraprastha Apollo Hospitals Medical Oncology Department Room No 11 Sarita Vihar Delhi Mathura Road New Delhi 110076

New Delhi
DELHI
110076
India 
Phone  9818521155  
Fax    
Email  singhaloncocare@yahoo.co.in  
 
Source of Monetary or Material Support  
Whole leaf Organics Pvt Ltd M075 Vill Road New Mangla Puri New Delhi 110030 India 
 
Primary Sponsor  
Name  Whole leaf Organics Pvt Ltd 
Address  M075 Vill Road New Mangla Puri New Delhi 110030 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
Dr Manish Singhal  Indraprastha Apollo Hospitals  Medical Oncology Department Room No 11 Sarita Vihar Delhi Mathura Road New Delhi 110076
New Delhi
DELHI 		 9971347203

singhaloncocare@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Biomedical Research Indraprastha Apollo Hospitals New Delhi   Approved 
Institutional Ethics Committee Biomedical Research Indraprastha Apollo Hospitals New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:C801||Malignant (primary) neoplasm, unspecified. Ayurveda Condition: KARKATAKAVISHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Cannabis, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2.5(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: NA), Additional Information: NA
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult patients
Histopathologically confirmed cancer diagnosis
Moderate or severe pain
Stable regime of pain management inclusive of NSAIDS weak opioid opioids
Palliative intent therapy
 
 
ExclusionCriteria 
Details  Major psychiatric disorder
Cardiovascular disorder
Epilepsy
Significant renal or hepatic impairment
Pregnancy
Lactating Women
Patients who were currently using or had used cannabinoid based medications within 30
days of study entry 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in pain relief
Using baseline assessment measures gathered at visit 0
Screening assessments collected at visits 1 to 5 and follow up
will be used to determine whether the administration of
cannabinoid rich oral cannabis extract will improve pain relief
in individuals with chronic pain Assessments will be made
using a visual analogue scale 		 90 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life   Baseline 30 days 60 days 90 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 2 
Date of First Enrollment (India)   30/06/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Medical Journals and on company website

  6. For how long will this data be available start date provided 30-06-2025 and end date provided 30-06-2040?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Pilot Study to assess the efficacy of cannabinoid-rich Oral cannabis extract for pain management in cancer patients undergoing cancer directed treatment (surgery, systemic therapy, radiation therapy) and who have received systemic analgesics.
 
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