Safety of Anal Curcumin

Conditions

• Anal High Grade Squamous Intraepithelial Lesion

Eligibility Criteria

Sex

ALL

Age

30 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Curcuminoid Capsules — DRUG
  500 mg curcuminoids from C3 Complex capsule. Curcuma longa (Turmeric), a constituent of the spice turmeric, is considered a low-toxicity, dietary-derived agent with chemopreventive and therapeutic benefits Study participants will be instructed to insert the curcumin capsules gelatin intra-anally every day for a 14-day treatment period. Escalating doses

Study Details

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.

Key Dates

Start date

Mar 17, 2025

Status verified

May 2026

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

48 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Level 1
  Participants will receive a supply of curcumin gelatin capsules to insert 500 mg intra-anally every day for a 14-day treatment period
• Experimental: Dose Level 2
  Participants will receive a supply of curcumin gelatin capsules to insert 1000 mg intra-anally every day for a 14-day treatment period
• Experimental: Dose Level 3
  Participants will receive a supply of curcumin gelatin capsules to insert 1500 mg intra-anally every day for a 14-day treatment period
• Experimental: Dose Level 4
  Participants will receive a supply of curcumin gelatin capsules to insert 2000 mg intra-anally every day for a 14-day treatment period
• Experimental: Dose Level 5
  Participants will receive a supply of curcumin gelatin capsules to insert 2500 mg intra-anally every day for a 14-day treatment period
• Experimental: Dose Level 6
  Participants will receive a supply of curcumin gelatin capsules to insert 3000 mg intra-anally every day for a 14-day treatment period
• Experimental: Dose Level 7
  Participants will receive a supply of curcumin gelatin capsules to insert 3500 mg intra-anally every day for a 14-day treatment period
• Experimental: Dose Level 8
  Participants will receive a supply of curcumin gelatin capsules to insert 4000 mg intra-anally every day for a 14-day treatment period

Primary Outcome Measure

Maximum curcumin tolerated dose [ Time Frame: Up to 22 days after treatment ]

Central Contacts

• Lisa Flowers, MD, MPH
  404-251-8931
  [email protected]

Locations (2)

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