Clinical trial · Interventional
Safety of Anal Curcumin
An Incremental Dose Escalation Trial of Safety and Tolerability of Curcumin
NCT06626230CI-TRIAL-00122561recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to see if curcumin can reverse anal high-grade squamous intraepithelial lesions (aHSIL) (high-grade anal precancerous cells or high-grade abnormal cells) in people living with HIV to avoid current treatments such as ablation (destroying abnormal cells with heat or surgical excision (cutting out the abnormal cells)), which have potential short- and long-term side effects.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal High Grade Squamous Intraepithelial Lesion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Curcuminoid Capsules | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Dose Level 1
- description
- Participants will receive a supply of curcumin gelatin capsules to insert 500 mg intra-anally every day for a 14-day treatment period
- interventionNames
- Drug: Curcuminoid Capsules
- type
- EXPERIMENTAL
- label
- Dose Level 2
- description
- Participants will receive a supply of curcumin gelatin capsules to insert 1000 mg intra-anally every day for a 14-day treatment period
- interventionNames
- Drug: Curcuminoid Capsules
- type
- EXPERIMENTAL
- label
- Dose Level 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
Show eligibility criteria text
Major Inclusion Criteria: * 30 and older * Have biopsy-proven anal intraepithelial neoplasia (AIN) 2, AIN 3 without previous treatment * Or cytology results for ASC-H or HSIL * Able and willing to complete Study Diary * Other inclusion criteria apply Exclusion Criteria: * Have a clinically significant chronic medical condition that is considered progressive, such as but not limited to coronary disease, congestive heart failure, chronic obstructive lung disease, and diabetes mellitus. Chronic nonprogressive or intermittent syndromes are not excluded, including migraine headaches, mild reactive airway disease, controlled hypertension, stable pain syndromes, or benign gastric reflux. * Have any history of anal cancer malignancy. * Pregnant or planning to become pregnant in the next three months. * Have a history of sensitivity or allergy to any compound used in this study. * Have Grade 2 or higher renal or hematology abnormality, * Are currently using, or in the last year have used intravenous drugs (except for therapeutic use), recreational drugs, or alcohol abuse. * Other exclusion criteria apply
References
Publications (0)
Data not yet available
No reference posted for this study.