NCT04266275Not yet recruitingPhase 2
Topical Curcumin for HPV Related Cervical Disease
An Investigation in the Use of Curcumin Topical Herbal Agent for the Treatment of Cervical Intraepithelial Neoplasia
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
The purpose of this study is to see if curcumin can suppress HPV infection in women with low-grade squamous intraepithelial lesions (LSIL) disease or treated high-grade squamous intraepithelial lesions (HSIL) disease. This study plans to explore the effect of curcumin as a potential medical treatment in HIV-uninfected and infected women with mild precancerous lesions of the cervix or recently treated high-grade precancerous lesions at risk for persistent HPV infection. About 200 women with low-grade precancerous lesions of the cervix or recently treated high-grade precancerous lesions will be enrolled to either insert 2000 mg of curcumin capsules in their vagina once a week or placebo after undergoing colposcopy or loop electrosurgical excision procedure (LEEP). They will have a repeat visit in 6 months where they will undergo a Pap smear and HPV test to determine if there are higher rates of HPV clearance after curcumin administration. If HPV is present or the Pap smear is abnormal, patients will then undergo colposcopic examination to evaluate cervical histology.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 26 Dec 2019
- Start date
- Apr 2027
- Primary completion date
- Oct 2028
- Lead sponsor
- Lisa Flowers
- Diseases
- Cervical cancer
- NCT number
- NCT04266275
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From Apr 2027 to the primary completion date, Oct 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous hysterectomy
- Prior diagnosis of cervical cancer, treated or untreated
Other illness
- Not adherent to anti-retroviral therapy (cART) (HIV infected participants)
- 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
Lab values
- CD4 count =\<200 cells/ml and detectable viral load within the last 3 months (only for HIV-positive participants)
Other
- Untreated HSIL or invasive features on colposcopy and the biopsy specimen
- Lactating and pregnant people
- Patient with irregular cycles (more than once a month)
- Not on reliable birth control.
- Inability to provide informed consent
Who the study is looking for
- 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
Age in the registry: 21 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Grady Memorial Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Grady Hospital - Ponce De Leon Clinic Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.