Chlorhexidine and Garlic Extract as Potential Topical Virucidal Therapeutic Agents of Non-Genital Warts: A Prospective, Randomized, Controlled, Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- ●Evaluate the efficacy and safety of topical chlorhexidine (2%) solution vs garlic extract (15%) solution in treating non-genital warts
研究概览
简要总结
Aim(s) of the Research:
- Evaluate the efficacy and safety of topical chlorhexidine (2%) solution vs garlic extract (15%) solution in treating non-genital warts.
- Explore possible relation between therapeutic response with demographic/clinical data.
- Identify patients satisfaction with each agent.
详细描述
Cutaneous warts or verruca are common, benign skin growths caused by human papilloma virus (HPV).
There are several therapeutic modalities for warts: include destructive agents (keratolytics, cryotherapy, curettage and cautery, laser, photodynamic therapy), antimitotic agents (podophyllin, bleomycin, retinoids), immune stimulants (topical sensitizers, cimetidine), and topical virucidal agents (formaldehyde, glutaraldehyde) Unfortunately, no single treatment is satisfactory for all patients. Chlorhexidine gluconate(CHX) is a gluconate salt with a broad-spectrum antiseptic action against Gram-Positive, Gram-negative bacteria, aerobes, facultative anaerobes, and fungi such action is mediated through increasing the permeability of the cell walls of microbes, causing their lysis.
Additionally, evidence indicates an in vitro effect against many viruses such as influenza A, parainfluenza, herpes virus 1, cytomegalovirus, hepatitis B, HIV and SARS-CoV-2.
It was hypothesized that the biophysiological mechanisms for the virucidal effect of CHX may be exerted through lysis of viral envelope, deterioration of nucleotide carbon chains, and inactivation and/or blocking of viral proteins.
Garlic (Allium sativum) is one of the most widely used medicinal plants with high therapeutic effects.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with the clinical diagnosis of common or plantar warts.
排除标准
- •Pregnancy and lactation.
- •Chronic systemic diseases such as chronic renal failure, hepatic insufficiency, and cardiovascular disorders.
- •Patients with inflamed lesions
- •Use of systemic or topical treatments during the last month before enrollment.
- •Individuals with history of allergic reactions to garlic or chlorhexidine
- •Patient with generalized dermatitis or allergic skin disorders
研究组 & 干预措施
garlic extract
Garlic will be collected from Medicinal Plant station, Pharmacognosy Department, Faculty of Pharmacy, Assiut University.
The fresh garlic bulbs will be crushed. Extraction will be done using maceration method with Ethanol for 24 h at room temperature.
Freeze-drying method will be used to remove solvent and give dry powder. Dry powder will be mixed with isopropyl alcohol in a ultrasonic bath to solve thoroughly.
The soluble garlic extract will be added to a mixture of Polyethylene Glycol. The topical garlic formulation will be prepared for each time for two weeks-use and will be kept in dark glass containers in refrigerator till prescription.
•Group 1: will apply Vaseline over the normal skin surrounding the lesion(s) then a cotton soaked with garlic extract (15%) solution will be applied under occlusion with a plastic tape for one hour and then washed by tap water daily for 6 weeks.
干预措施: garlic extract (15%) solution (Drug)
chlorhexidine
Chlorhexidine 4% (Laries, manufactured by: Smartec Egypt) will be diluted with equal amount of distilled water to obtain a concentration of 2%.
•Group 2: will apply Vaseline over the normal skin surrounding the lesion(s) then a cotton soaked with topical chlorhexidine (2%) solution will be applied under occlusion with a plastic tape for one hour and then washed by tap water daily for 6 weeks.
干预措施: topical chlorhexidine (2%) solution (Drug)
group3
•Group 3: (control) will use normal saline 0.9% as a placebo (they will be treated later on after completion of the study using any of the standard therapies for non-genital warts).
干预措施: Saline (Drug)
结局指标
主要结局
●Evaluate the efficacy and safety of topical chlorhexidine (2%) solution vs garlic extract (15%) solution in treating non-genital warts
时间窗: 6weeks up to 3 month
will be evaluated by changing in the size (using ruler) and the number of lesions.
●Side effects (systemic of local) as burning, itching, erythema, pigmentary changes, ulceration, and scarring
时间窗: 6weeks up to 3 month
will be evaluated at each visit.
次要结局
未报告次要终点
研究者
Shaimaa Nassar Abd El Hameed Ali
Assuit seed street
Assiut University