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Polyphenol

Topical Curcumin for HPV Related Cervical Disease

Phase 2

Waitlist Available

Led By Lisa Flowers, MD

Research Sponsored by Lisa Flowers

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of a cervix

HIV-uninfected and infected women (without current AIDS-defining illness)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Awards & highlights

Study Summary

This trial is exploring whether the spice curcumin can help to treat or prevent HPV infection in women who have either low-grade squamous intraepithelial lesions (LSIL) or recently treated high-grade squamous intraepithelial lesions (HSIL). If successful, this could provide a new, non-invasive treatment for HPV infection.

Who is the study for?

This trial is for women with low-grade cervical precancerous lesions or those treated for high-grade lesions, at risk of persistent HPV. Participants must be on reliable birth control, not pregnant or lactating, without a history of cervical cancer or hysterectomy. HIV-positive women must have controlled infection.Check my eligibility

What is being tested?

The study tests if vaginal curcumin capsules can clear HPV in affected women compared to a placebo. About 200 participants will insert either curcumin (2000 mg) or placebo weekly and undergo follow-up Pap smears and HPV tests after six months.See study design

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include local irritation or discomfort from the vaginal insertion of curcumin capsules.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a cervix.

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I do not have HIV or AIDS.

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I am a woman who had a LEEP procedure for HSIL and healed well within the last 6 weeks.

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I have a confirmed low-grade or recently treated high-grade lesion.

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I don't have risk factors for severe cervical disease based on my latest exams.

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I am HIV-positive, on antiretrovirals, with a CD4 count over 200 and an undetectable viral load for 3+ months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HPV Clearance

Secondary outcome measures

Disease Recurrence

Other outcome measures

Participant Discontinuation

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Curcumin ArmExperimental Treatment1 Intervention

Participants in this arm will use 2000 mg of intravaginal curcumin once a week for 20 weeks

Group II: Placebo ArmPlacebo Group1 Intervention

Participants in this arm will use 2000 mg of intravaginal placebo once a week for 20 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Curcumin C3 Complex

2008

Completed Phase 2

~40

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lisa FlowersLead Sponsor

Lisa Flowers, MDPrincipal InvestigatorEmory University

3 Previous Clinical Trials

1,782 Total Patients Enrolled

Media Library

Curcumin C3 Complex (Polyphenol) Clinical Trial Eligibility Overview. Trial Name: NCT04266275 — Phase 2

Cervical Cancer Research Study Groups: Curcumin Arm, Placebo Arm

Cervical Cancer Clinical Trial 2023: Curcumin C3 Complex Highlights & Side Effects. Trial Name: NCT04266275 — Phase 2

Curcumin C3 Complex (Polyphenol) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04266275 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum sample size for this research project?

"This particular trial is not recruiting at the moment. It was initially posted on September 1st, 2022 and last updated on April 29th, 2022. If you're interested in other similar studies, there are 327 clinical trials for uterine cervical neoplasms and 17 for Curcumin C3 Complex that are currently enrolling patients."

Answered by AI

What other scientific papers have been published that mention Curcumin C3 Complex?

"There are a total of 17 clinical trials studying Curcumin C3 Complex, 3 of which are in Phase 3. The majority of these studies originate from Farmington Hills, Michigan; however, there are research centres in 21 different locations across the country."

Answered by AI

What are the possible side effects of taking Curcumin C3 Complex?

"Curcumin C3 Complex is a Phase 2 medication, meaning that while there is evidence of its safety, there is currently no data to support claims of efficacy."

Answered by AI

Are there still openings in this research project for people who want to participate?

"This particular trial, which was posted on September 1st, 2022 and last updated on April 29th, 2022 is not currently looking for new participants. Although this study has halted recruitment, there are 344 other trials presently searching for patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Topical Curcumin for HPV Related Cervical Disease

Lisa Flowers 2023. "Topical Curcumin for HPV Related Cervical Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04266275.