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

NCT05969314 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-04-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cannabis capsules

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

Sponsors & Collaborators

  • Tata Memorial Hospital

    lead OTHER_GOV

Principal Investigators

  • Rajendra A Badwe, MS · Director, Tata Memorial Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-08
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05969314 on ClinicalTrials.gov