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ACTIVE NOT RECRUITING
NCT05969314
PHASE1

To Check Safety of Ayurvedic Oral Cannabis in Breast and Head and Neck Cancer

Sponsor: Tata Memorial Hospital

View on ClinicalTrials.gov

Summary

Phase 1 study to assess the pharmacokinetic availability and safety and tolerability profile of one such ayurvedic preparation which contains 5 mg THC:CBD 1:1 preparation. Other than the PK profile, we will also be studying its effect on gene expression profiling of the breast and head neck oral cavity squamous cell carcinoma tissue.

Official title: Phase I Study of Safety and Feasibility of Ayurvedic Oral Cannabis Preparation in the Peri-operative Period in Breast and Oral Cavity Squamous Cell Cancer

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2022-06-08

Completion Date

2025-06-30

Last Updated

2025-04-11

Healthy Volunteers

No

Interventions

DRUG

Cannabis capsules

Cannabis capsules containing 5 mg of THC and CBD each or 2.5 mg of THC and CBD each.

Locations (2)

Tata Memorial Center

Mumbai, Maharashtra, India

Tata Memorial Hospital

Mumbai, Maharashtra, India