| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 |
|
|
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. |