Topical Curcumin for HPV Related Cervical Disease

Recruiting at 2 trial locations

Overseen By Lisa Flowers, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Lisa Flowers

Must be taking: Antiretrovirals, Birth control

Disqualifiers: Pregnancy, Irregular cycles, Hysterectomy, Cervical cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 20 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if curcumin capsules can help clear HPV infections in women with mild or recently treated severe precancerous cervical lesions. The study includes both HIV-infected and uninfected women. Curcumin, a substance from turmeric, might reduce inflammation and infection, helping to prevent cervical cancer. Curcumin and curcumin containing polyherbal preparations have demonstrated anti-microbial and anti-viral properties in pre-clinical studies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are HIV-positive, you must continue your anti-retroviral therapy.

What data supports the effectiveness of the treatment Curcumin C3 Complex for HPV related cervical disease?

Research shows that curcumin, a key component of the Curcumin C3 Complex, has demonstrated anti-viral properties and has been effective in clearing HPV infections in some studies. For example, a study found that curcumin vaginal capsules led to a higher rate of HPV clearance compared to a placebo, and another case report showed improvement in HPV-related lesions with curcumin treatment. ^{1 2 3 4 5}

Is topical curcumin safe for humans?

Topical curcumin has been studied for safety, and no serious side effects were reported. Some mild to moderate vaginal irritation and itching were noted, but overall, it was considered safe for use in humans. ^{1 2 4 6 7}

How is the treatment Curcumin C3 Complex different from other treatments for HPV-related cervical disease?

Curcumin C3 Complex is unique because it is a natural compound derived from turmeric that has shown promising antiviral and anticancer properties specifically against HPV-related cervical disease. Unlike other treatments, it works by modulating signaling pathways, reducing viral oncogene expression, and inducing apoptosis (programmed cell death) in infected cells, offering a novel approach to managing HPV infections and associated cervical conditions. ^{1 4 6 8 9}

Research Team

Lisa Flowers, MD

Principal Investigator

Emory University

Eligibility Criteria

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.

Inclusion Criteria

I have a cervix.

I do not have HIV or AIDS.

Reliable follow-up and contact information

Exclusion Criteria

I am HIV positive and not following my HIV treatment plan.

I have had my uterus removed.

CD4 count =<200 cells/ml and detectable viral load within the last 3 months (only for HIV-positive participants)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 2000 mg of intravaginal curcumin or placebo once a week for 20 weeks

20 weeks

Weekly self-administration

Follow-up

Participants undergo a Pap smear and HPV test to determine HPV clearance

6 months

1 visit (in-person)

Treatment Details

Interventions

• Curcumin C3 Complex
• Placebo

Trial Overview 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.

Participant Groups

Group I: Curcumin Arm Experimental Treatment 1 Intervention

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

Group II: Placebo Arm Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Lisa Flowers

Lead Sponsor

Trials

4

Recruited

760+

References

1. Thailand pubmed.ncbi.nlm.nih.gov

Clearance of cervical human papillomavirus infection by topical application of curcumin and curcumin containing polyherbal cream: a phase II randomized controlled study. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Phase I dose-escalation trial of intravaginal curcumin in women for cervical dysplasia. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Association of Four Natural Molecules-EGCG, Folic Acid, Vitamin B12, and HA-To Counteract HPV Cervical Lesions: A Case Report. [2023]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

An Alternative Treatment for Vaginal Cuff Wart: a Case Report. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Case Report of a Human Papillomavirus Infection Treated with Green Tea Extract and Curcumin Vaginal Compounded Medications. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Curcumin as a multifaceted compound against human papilloma virus infection and cervical cancers: A review of chemistry, cellular, molecular, and preclinical features. [2022]

7. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Topical imiquimod treatment for human papillomavirus infection in patients with and without cervical/vaginal intraepithelial neoplasia. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Antitumor action of curcumin in human papillomavirus associated cells involves downregulation of viral oncogenes, prevention of NFkB and AP-1 translocation, and modulation of apoptosis. [2022]

9. France pubmed.ncbi.nlm.nih.gov

Curcumin and Ellagic acid synergistically induce ROS generation, DNA damage, p53 accumulation and apoptosis in HeLa cervical carcinoma cells. [2022]