The Effect of Oral Nanocurcumin as an Adjuvant Therapy for Anogenital Warts: Evaluation of Clinical Improvement, Nuclear Factor Kappa-Light-Chain-Enchancer of Activated B Cells, Interferon-γ, and FOXP3+ Regulatory T Cell From Lesions Tissue
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Clinical improvement in patients with AGW
研究概览
简要总结
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.
详细描述
The study is expected to enhance various aspects, including education, healthcare services, and research development aspects. This research aims to improve the understanding of the efficacy of oral nanocurcumin administration in patients with AGW and its implications on clinical aspects and its biomarkers (IFN-γ, Treg FOXP3+, and NF-kB levels) in AGW lesions. Therefore, it is anticipated to enhance the clinical improvement of the patients, potentially reducing the transmission rate of the disease. Furthermore, this study serves as a foundation for the development of future therapies for patients with AGW, opening avenues for further research endeavors, and exploring traditional medicine as a medical therapy with a robust evidence base.
Subjects were obtained from multiple centers in Indonesia, predominantly in Jakarta and nearby the area, such as, from the Dermatology & Venereology outpatient clinic at Dr Cipto Mangunkusumo hospital, HIV and STI Clinics at Tambora Health Center (CINTTA Clinic), Penjaringan Health Center, Kalideres Health Center, Taman Sari Health Center, Cengkareng Health Center, and several foundations that provide care for HIV and STI patients. The acetic acid testing was conducted to confirm the diagnosis of AGW.
Lesions meeting the research criteria (a minimum of 3 lesions, and the diameter of at least one lesion is between 5 mm to under 50 mm) continued to be treated with 90% TCA solution. If participants had giant AGW lesions, they were referred to the Surgery outpatient clinic at Dr Cipto Mangunkusumo hospital for further management. Participants underwent 8 weekly visits.
Sample collection and drug administration protocol included: sample collection using wet cotton swabs swiped on the lesion for biomarkers (IFN-γ, FOXP3+TReg, and NFĸB) examination, as well as blood collection for HIV and CD4+ examination at week 1, 4, and 8, application of 90% TCA solution + nanocurcumin/control capsule administration at every visit for 8 weeks, along with control and clinical evaluation / side effect assessment. If lesions were no longer visible and the acetic acid test was negative by week 8, the lesions were considered healed and no further application of 90% TCA solution was conducted, but biomarkers examination continued. If lesions were still visible, application would continue until lesions were healed, with treatment continued at a center accessible to the patient. Participants who tested positive for HIV were referred to the HIV outpatient clinic for appropriate treatment.
Additional details related to the drug administration and sample collection protocol included:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Capsules with active ingredient /Nanocurcumin
Participants received a dosage of 200mg capsules with active ingredient /Nanocurcumin per day after breakfast, for 8 weeks.
干预措施: Curcumin Oral Capsule (Drug)
Placebo
Participants received a dosage of 200mg capsules without Nanocurcumin per day after breakfast, for 8 weeks
干预措施: Blood sample collection (Procedure)
Capsules with active ingredient /Nanocurcumin
Participants received a dosage of 200mg capsules with active ingredient /Nanocurcumin per day after breakfast, for 8 weeks.
干预措施: Trichloroacetic acid (Drug)
Capsules with active ingredient /Nanocurcumin
Participants received a dosage of 200mg capsules with active ingredient /Nanocurcumin per day after breakfast, for 8 weeks.
干预措施: Blood sample collection (Procedure)
Capsules with active ingredient /Nanocurcumin
Participants received a dosage of 200mg capsules with active ingredient /Nanocurcumin per day after breakfast, for 8 weeks.
干预措施: Cotton swab (Procedure)
Placebo
Participants received a dosage of 200mg capsules without Nanocurcumin per day after breakfast, for 8 weeks
干预措施: Trichloroacetic acid (Drug)
Placebo
Participants received a dosage of 200mg capsules without Nanocurcumin per day after breakfast, for 8 weeks
干预措施: Cotton swab (Procedure)
结局指标
主要结局
Clinical improvement in patients with AGW
时间窗: 7 weeks
The percentage reduction in the volume of AGW lesions in visit 8 compared to the initial volume.
次要结局
- Level of FOXP3+Treg in lesions of AGW patients(7 weeks)
- Level of IFN-γ in lesions of AGW patients(7 weeks)
- Level of NFĸB in lesions of AGW patients(7 weeks)
研究者
dr Hernayati Hutabarat
Dermatovenereologist, Principal Investigator
Indonesia University