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临床试验/NCT03745183
NCT03745183已完成不适用

Senna Alata Leaf Decoction as a Treatment for Tinea Imbricata in an Indigenous Tribe in Southern Philippines :a Pilot Study

Philippine Dermatological Society0 个研究点目标入组 20 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
主要终点
Improvement in disease severity

研究概览

简要总结

Background: Tinea imbricata ("tokelau") is a rare form of tinea corporis which is caused by Trichophyton concentricum. It is endemic among the T'boli tribe in Sarangani, Philippines . Temporary remissions, despite antifungal treatment, can be attributed to factors such as genetic susceptibility, widespread poverty, poor hygienic conditions and overcrowding. Limited access to commercial antifungal medications makes the treatment of tinea imbricata a pressing public health concern.

Senna alata grows abundantly in the areas where the T'boli tribe resides. Anecdotal reports about its efficacy as a treatment for tinea imbricata exist and need to be further validated.

Objective: This study aims to assess the efficacy and safety of a community-prepared Senna alata leaf decoction in the treatment of tinea imbricata.

Methods: This study is a preliminary open label, before and after clinical trial. Enrolled patients were taught how to make Senna alata leaf decoction and were asked to apply it as a leave-on body wash once a day for 28+/-3 days. Disease severity, pruritus visual analogue scale scores (VAS) and potassium hydroxide smear (KOH) of the skin scrapings were evaluated before and after treatment. Two separate assessors evaluated post treatment severity based on standard photographs. Diagnostic concordance was determined using Cohen's kappa statistics. Wilcoxon paired signed-rank test was used to analyzed before and after clinical parameter scores. Adverse drug events were recorded.

详细描述

Introduction:

Tinea imbricata is a rare form of tinea corporis caused by Trichophyton concentricum, an anthropophilic dermatophyte. Its lesions would present embossed "maze-like" or lace-like pattern of embosed concentric rings mainly on the trunk and extensor surfaces of both extremities, sparing the palms, soles, hair and nails. Due to the rarity of the disease, limited epidemiologic and prevalence studies exist. (Halickova, 2008) Tine imbricata is known to be endemic in places such as the Pacific Islands of Oceana, South East Asia, India, Sri-Lanka, North, Central and South America. (Halickova, 2008 and Pihet, 2008) The first case was discovered in the southern Philippines by William Dampier in 1789. (Fernandez, 1962) In 2010, cases of tinea imbricata were found to still exist among T'boli tribe who live in the mountainous areas of Kiamba in Sarangani through the University of the Philippines- Department of Science and Technology (UP-DOST) telemedicine project. (Carpio, 2010) The inherited susceptibility of T.concentricum infection may explain why the disease affects only specific group of people. The most accepted inheritance pattern is autosomal recessive attributing to the inherited defect in cell-mediated immunity, which results to failure of the T-lymphocytes to become sensitized to the fungi and mount an immune response. Majority of the patients are blood-related individuals and rarely infect unrelated individuals even after close contact or cohabitation., Other risk factors are isolated and primitive living conditions especially in humid areas, widespread poverty, poor hygienic conditions and overcrowding. (Bonifaz, 2003 and Bonifaz, 2004) Antifungals are the mainstay treatment against Trichophyton concentricum. Griseofulvin, 500 mg/tab twice daily, and terbinafine, 250 mg once daily, for at least 4 weeks result to complete resolution. (Wingfield, 2004) However, these commercial antifungal preparations are costly and not readily available in the health centers of Sarangani. Furthermore, even with systemic antifungal intake, disease remission would only last for at least 8 weeks post-treatment. Alternative treatment options that will promote clearance of the infection that are accessible, inexpensive and practical to use should be explored.

Antifungals from local plant sources are one of the potential alternatives. Among these, Senna alata has validated efficacy on superficial dermatophytic infections and is included in the Philippine National Drug Formulary. It is a tropical ornamental shrub, also known as candle bush and locally as "Akapulko, which grows throughout the low and medium altitude areas of the country including Sarangani.

Chemical screening of the leaves and roots of S. alata revealed the anthraquinones and its derivatives such as aloe, emodin, chrysophanol, and rhein, are the major components responsible for its antifungal activity. These are naturally occurring phenolic compounds are readily oxidized to form a phenolate ion or quinone, which aids in the scavenging and entrapment of microorganisms. Furthermore, phenols impair a variety of enzyme systems that are involved in the microorganism's energy production. They also disrupt the integrity of the cell membrane and interfere with the synthesis of its structural components. (Hemen and Ledwani,2012) There were anecdotal reports on the efficacy of akapulko decoction against tinea imbricata. A decoction is the liquid resulting from concentrating the essence of the substance by heating or boiling, especially a medicinal preparation made from a plant. Plant parts such as leaves can be used in decoctions. The first anecdotal report was published by Dofitas and Non last 2010. Senna alata leaf decoction was used as leave-on body wash in a T'boli woman resulting in complete clearance of the lesions. In the case series by Carpio et. al., S. alata leaf decoction resulted to partial improvement of the skin lesions. (Dofitas and Non, 2010 and Caprio, 2010) At present there are no existing clinical trials about the use of akapulko as an alternative or complementary treatment to tinea imbricata. The favorable results from the anecdotal and case series studies pave the way for the consideration of akapulko decoction as a part of an accessible and affordable treatment regimen for tinea imbricata.

II Objectives:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Indigenous T'boli patient aged 18 years old and above, male or female
  • Patients with clinically diagnosed tinea imbricata with microscopically confirmed skin scraping positive for potassium hydroxide (KOH)

排除标准

  • Patients who were treated or undergoing treatment with topical anti-fungal for 2 weeks or oral anti-fungal 1 month before the study
  • Patients who were taking other systemic medications such as cytotoxic and immunosuppressive drugs
  • Patients with known liver disease, kidney dysfunction, hematologic problems (e.g. anemia)
  • Patients with or suspected allergy to Senna alata extract
  • The participation of the subjects were completely voluntary. Participants were allowed to withdraw from the study at anytime and for any reason without prejudice to their subsequent medical treatment.

研究组 & 干预措施

Senna alata leaf decoction

Experimental

The participants were instructed to take a bath once a day using a syndet bar and to towel dry their skin before applying the akapulko decoction. Fresh decoction was prepared by the patients every day. After a bath, the patient applied the fresh cooled decoction by hand on the whole body especially on the affected areas and left it to dry. Approximately one glassful (350ml) of akapulko decoction should be consumed for one whole body application. The total duration of daily application should be 4 weeks (28 days +3) until the next outcome assessment.The patients were given illustrated, laminated instructional materials and a tabulated checklist of instructions on how to prepare and apply the decoction which served as a monitoring sheet of each patient.

干预措施: Senna alata leaf decoction (Other)

结局指标

主要结局

Improvement in disease severity

时间窗: Before and after the treatment period of 1 month

Disease severity was measured by body surface area of involvement, erythema and scaling . After which, their composite scores were combined and graded no disease, mild, moderate and severe. Body surface area of involvement grading Score Characteristic 0 No lesions 1. Lesions occupy an aggregate surface area less than or equal to 5cm x 5cm 2. Aggregate surface area greater than 5cm x 5cm but less than 10cm x 10cm 3. Aggregate surface area of greater than 10cm x 10cm Erythema grading Score Characteristic 0 No erythema 1. Nearly imperceptible erythema 2. Moderate erythema (pinkish skin) 3. Intense erythema Scaling grade Score Characteristic 0 No scaling 1. Fine white scales 2. Moderate scales 3. Large scales Composite Scores Category Score No disease 0 Mild For composite score of 1-3 Moderate For composite score of 4 -6 Severe For composite score of 7- 9

次要结局

  • Adverse Events(Before and after the treatment period of 1 month)

研究者

发起方
Philippine Dermatological Society
申办方类型
Network
责任方
Sponsor

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