The Effect of Oral Nanocurcumin as an Adjuvant Therapy for Anogenital Warts: Evaluation of Clinical Improvement, NFĸB, IFN-γ, and FOXP3+TReg From Lesions Tissue

The goal of this clinical trial is to demonstrate the adjuvant administration of oral nanocurcumin in 90% TCA therapy that increases the proportion of clinical improvement in patients with Anogenital Warts (AGW), mediated by NFĸB, IFN-γ, and FOXP3+Treg. Specific objectives of this clinical trial include: * To prove that the oral administration of nanocurcumin decreases the levels of IFN-γ, FOXP3+Treg, and NFĸB in lesions of AGW patients, and * To demonstrate that the reduction in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions is associated with the proportion of clinical improvement in AGW patients undergoing TCA 90% therapy with adjuvant of oral nanocurcumin. The main questions it aims to answer are: * Does adjuvant oral nanocurcumin administration in 90% TCA therapy increase the proportion of clinical improvement in patients with AGW compared to controls (90% TCA therapy alone)? * Is there a greater decrease in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions of patients with AGW given adjuvant oral nanocurcumin compared to controls? * Is the decrease in IFN-γ, FOXP3+TReg, and NFĸB levels in lesions of patients with AGW, with adjunctive oral nanocurcumin administration in 90% TCA therapy, associated with the degree of clinical improvement in patients with AGW? Participants will be divided into 2 groups. The first one was given capsules without active ingredients/nanocurcumin (control group), and the second one was given capsules with nanocurcumin (experimental group), both group received a dosage of 200mg capsules per day after breakfast, for 8 weeks. The researchers conducted a comparison between those 2 groups to assess whether the adjuvant administration of oral nanocurcumin in 90% TCA therapy enhances the proportion of clinical improvement in patients with AGW.

Sex

All

Minimum age

18 Years

Maximum age

60 Years

Inclusion Criteria:

* Male and female aged 18-60 years.
* Clinically diagnosed with anogenital warts (AGW) with typical features and positive acetic acid test.
* Have AGW lesions in the extragenital and/or perianal area, with a minimum of 3 lesions, and the diameter of at least one lesion is between 5 mm to under 50 mm.
* Have not received AGW therapy within the last 2 weeks.
* Agree to participate in the study, including all laboratory sample collection procedures, and sign an informed consent form.

Exclusion Criteria:

* Infection within AGW lesions, ulceration, or suspicion of malignancy, and/or currently experiencing fever or other systemic infections.
* Patients with a history of autoimmune diseases.
* History of allergy or severe adverse reactions to curcumin/turmeric.
* Patients with blood coagulation disorders.
* History of malignancy.
* Consumption of steroid and nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, mefenamic acid, diclofenac, aspirin, paracetamol, and antalgic, for a minimum of 3 days prior to the study.
* Consumption of traditional or modern herbal remedies or supplements for a minimum of 7 days prior to the study.
* Use of immunomodulatory drugs (e.g., isoprinosine) for a minimum of 7 days prior to the study.
* Oral corticosteroid use for a minimum of 2 weeks prior to the study.
* Pregnancy and breastfeeding.

• BACKGROUNDRadi NKR RS, Khadium IAA, Hamood SS, Nadaabudellahkerbel. Evaluation of Gamma Interferon and Interleukin 10 Levels at Patient with Genital Wart, Iraq. Biochem Cell Arch. 2018;18:1083-6.