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CTRI Number  CTRI/2026/03/106030 [Registered on: 12/03/2026] Trial Registered Prospectively
Last Modified On: 11/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Testing Bhanga (Cannabis) Powder Before Surgery in Mouth Cancer Patients – Phase 1 Study 
Scientific Title of Study   Phase 1 study of safety and feasibility of Bhanga (Cannabis sativa) churna in the Pre-operative period in oral cavity squamous cell cancer. 
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 Vikram Gota  
Designation  Associate Professor  
Affiliation  Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)  
Address  KS-102, Department of Clinical Pharmacology Sector 22, Utsav Chowk - CISF Road, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210

Raigarh
MAHARASHTRA
410210
India 
Phone  02227405493  
Fax    
Email  vikramgota@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vikram Gota  
Designation  Associate Professor  
Affiliation  Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)  
Address  KS-102, Department of Clinical Pharmacology Sector 22, Utsav Chowk - CISF Road, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210

Raigarh
MAHARASHTRA
410210
India 
Phone  02227405493  
Fax    
Email  vikramgota@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vikram Gota  
Designation  Associate Professor  
Affiliation  Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)  
Address  KS-102, Department of Clinical Pharmacology Sector 22, Utsav Chowk - CISF Road, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210

Raigarh
MAHARASHTRA
410210
India 
Phone  02227405493  
Fax    
Email  vikramgota@gmail.com  
 
Source of Monetary or Material Support  
AYUSH CoE, Ministry of Ayush, Government of India 
 
Primary Sponsor  
Name  AYUSH CoE, Ministry of Ayush, Government of India 
Address  Ministry of Ayush, Ayush Bhawan, B Block, GPO Complex, INA, New Delhi - 110023. 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikram Gota  Advanced Centre for Treatment, Research and Education in Cancer  KS-102, Clinical Pharmacology, Cancer Research Institute
Raigarh
MAHARASHTRA 
02227408202

vikramgota@gmail.com 
Dr Vikram Gota  Tata Memorial Hospital  Clinical Research Secretriat, Main building 3rd Floor
Mumbai
MAHARASHTRA 
02227408202

vikramgota@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee 3  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:C060||Malignant neoplasm of cheek mucosa. Ayurveda Condition: ARBUDAH-SARVASARA-MUKHAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Bhanga (Cannabis sativa) , Reference: Ayurveda classics , Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: 50 ml of cow’s milk mixed with 4 g of crystal sugar), Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Histo-pathologically proven patients of oral cavity SCC.
Only clearly operable cancers planned to undergo upfront curative surgery.
Patient fit for surgery (ASA Grade I / II).
Patient voluntarily willing to give consent for study 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. The study will generate hypotheses for future investigation of Bhanga churna in the preoperative period to achieve improved clinical outcomes of OCSCC  Baseline
Day 21
Day 49 
 
Secondary Outcome  
Outcome  TimePoints 
2. Pharmacokinetic modelling
 
Day 1
Predose
30 min
1Hour
1.5 Hour
2 Hour
4 Hour
6 Hour
Day 21 Predose
30 min
1Hour
1.5Hour
2 Hour
4 Hour
6 Hour
Before Surgery
At the end of surgery
Post-operative Day 01
Post-operative Day 02
Post-operative Day 03
Post-operative Day 14  
Transcriptomic Analysis  Day 1 (Before dose intake)
Day 22 (On the day of surgery)
Before Surgery
During Surgery
At the end of Surgery 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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 1 
Date of First Enrollment (India)   20/04/2026 
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="1"
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 - NO
Brief Summary  

Cancer is a serious disease that is growing very fast around the world. In 2020, about 1.9 crore new cancer cases were reported, and India had the third highest number, after China and the USA. By the year 2040, cancer cases in India may increase by 57%, reaching over 20 lakh people. One common type of cancer in India is mouth cancer, which is part of head and neck cancers. It spreads quickly, comes back after treatment, and is more common in poor or developing countries like India. In India, the traditional system of medicine called Ayurveda has long used herbs and plants to treat diseases. Ancient Ayurvedic books mention cancer-like illnesses as “Arbuda” (big swelling) or “Granthi” (small swelling). One such plant used in Ayurveda is Bhanga, also known as Cannabis sativa. Cannabis contains natural chemicals called cannabinoids, such as THC and CBD, which may help kill cancer cells, stop their growth, reduce spreading, and support the body’s immune system.These cannabinoids work by attaching to special parts of the body called receptors. Some studies in the lab and in animals have shown that cannabis can cause cancer cells to die and may reduce inflammation, but there are only a few studies in humans. Cannabis can be taken as a capsule or spray. Capsules are easy to take and help measure the correct dose. The effects may take about two hours to appear. Some side effects like dizziness or sleepiness have been reported, but most are mild. New studies suggest that natural cannabis may work better than lab-made versions because all parts of the plant work together to give better results. Our study aims to find out if Bhanga is safe to use before surgery in patients with mouth cancer. We will give Bhanga in powder (churna) form, following Ayurvedic methods. This research hopes to offer a safe, low-cost treatment that supports patients before and after surgery, along with their regular cancer care.

 
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