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Topical Curcumin for HPV-Related Cervical Disease

This study is looking at whether a natural substance called Curcumin C3 Complex, which comes from turmeric, can help suppress human papillomavirus (HPV) infection in women. HPV can cause precancerous changes in the cervix, called low-grade squamous intraepithelial lesions (LSIL) or high-grade squamous intraepithelial lesions (HSIL). Researchers want to see if applying Curcumin C3 Complex vaginally can help clear the HPV infection. About 200 women will participate, including those with or without HIV, who have LSIL or treated HSIL. The main goal is to see if HPV clears up after 6 months. The study status is unclear.

Study design
This interventional study plans to enroll about 200 women. Participants will be randomly assigned to receive either Curcumin C3 Complex or a placebo (inactive substance).
What's involved
You would insert four 500 mg capsules (2000 mg total) of either Curcumin C3 Complex or placebo into your vagina once a week for 20 weeks, avoiding days during your period. You would also undergo a colposcopy or LEEP procedure.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, HPV clearance, will be measured at Month 6.

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NCT04266275

Topical Curcumin for HPV Related Cervical Disease

Not Yet Recruiting
PHASE2Ages 21+InterventionalTreatment
Lisa Flowers
~200 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Curcumin C3 ComplexPlacebo

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
HPV Clearance
Measured over Month 6

Conditions

Neoplasm Cervix

Explore related trials

Cervical Intraepithelial NeoplasiaCD4 GeneHIV Infection

Where it's being run

3 sites across 1 states
Georgia3

Study leadership

  • Lisa Flowers, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Lisa Flowers, MD
[email protected]
404-251-8931
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

HIV-uninfected and infected women (without current AIDS-defining illness)
Presence of a cervix
Biopsy-proven LSIL disease or recently treated HSIL disease
Adherence to combined anti-retrovirals (cART) if HIV infected
On continuous antiretrovirals with a cluster of differentiation 4 (CD4) count \>200 cells/ml with sustained undetectable viral load for at least 3 months (only for HIV-positive participants)
On reliable birth control: combined oral contraceptive pills (OCP), long-acting reversible contraception (LARC), bilateral tubal ligation (BTL) or Depo-Provera (birth control shot)
Willing to conform to the study requirements
Reliable follow-up and contact information
No risk factors for HSIL or microinvasive disease (no colposcopic features of microinvasion, adequate colposcopy and negative endocervical curettage)
For women with HSIL only, LEEP completed within 6 weeks preceding initial encounter with study staff and adequate wound healing

Exclusion

Untreated HSIL or invasive features on colposcopy and the biopsy specimen
Not adherent to anti-retroviral therapy (cART) (HIV infected participants)
CD4 count =\<200 cells/ml and detectable viral load within the last 3 months (only for HIV-positive participants)
Lactating and pregnant people
Patient with irregular cycles (more than once a month)
Not on reliable birth control.
Previous hysterectomy
Prior diagnosis of cervical cancer, treated or untreated
Inability to provide informed consent
Medical condition that interferes with the conduct of the study in the investigator's opinion
Evidence of active cervical infection or serious cervical disease necessitating surgery
Known bleeding diathesis

What this trial measures

  • HPV ClearanceMonth 6

    HPV clearance, assessed as the number of participants with undetectable high-risk HPV mRNA levels in the standard monolayer Pap test (ThinPrep), at 6 months will be compared between the curcumin and placebo study arms.