At a glance
ClinicalIndex Comparison RecordPhase 1Active· 12 enrolled
Drug / intervention
Cannabis capsulesdrug
Likely dose
Cannabis capsules 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Cannabis capsules for Breast Cancer and Oral Cancer. Active but no longer recruiting, targeting 12 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Oral Cancer
CountriesIndia
Collaborators--
Timeline
Phase 1ActiveOverdue
2023202420252026
Enrollment StartJun 2022
First PostedAug 2023
Primary CompletionJun 2025
TodayJul 2026
First PostedAug 1, 2023
Enrollment StartJun 8, 2022
Primary CompletionJun 30, 2025
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 2.9 years ago
Interventions
Cannabis capsulesdrug
Cannabis capsules containing 5 mg of THC and CBD each or 2.5 mg of THC and CBD each.