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Senna Alata Leaf Decoction as a Treatment for Tinea Imbricata

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03745183
Recruitment Status : Completed
First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Philippine Dermatological Society

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Tinea Imbricata Other: Senna alata leaf decoction Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This study is a preliminary open label, single arm, before and after clinical trial, that utilized Akapulko (Senna alata),a medicinal plant, leaf decoction in the treatment of tinea imbricata. Enrolled, who were recruited during the outreach mission were taught how to make a community-prepared akapulko decoction and were asked to apply it as a leave-on body wash once a day for 28+/-3 days.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Senna Alata Leaf Decoction as a Treatment for Tinea Imbricata in an Indigenous Tribe in Southern Philippines :a Pilot Study
Actual Study Start Date : November 2014
Actual Primary Completion Date : January 15, 2015
Actual Study Completion Date : January 15, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinea Infections

Arm Intervention/treatment
Experimental: Senna alata leaf decoction
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.
Other: Senna alata leaf decoction

Preparation of the akapulko decoction

  1. Remove the leaflets from the rachis of a mature leaf.
  2. Wash the mature leaflets thoroughly to remove dust, dirt and debris.
  3. In the clay, enamel, or stainless steel pot, place one glassful of closely packed chopped leaves (350 ml glass) and add 2 glasses (around 700ml) of clean water . Use the same glass for measuring the leaves and water.
  4. Cook the leaves and bring to a rolling boil.
  5. When the fluid is reduced to half, remove the decoction from the fire and cool slightly.
  6. Strain the mixture using cheesecloth and press the cut leaves in the strainer to make sure to get as much liquid out of them.
  7. Place the liquid in a clean container (bottle/jar with cover). Label the container clearly as "Akapulko".




Primary Outcome Measures :
  1. Improvement in disease severity [ Time Frame: 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



Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Before and after the treatment period of 1 month ]
    Presence of adverse drug effects were noted. Subjects were instructed to report to the research assistants or to the local health center in case any of these adverse drug events occurred for proper management. Participants with mild to severe adverse drug effects were withdrawn from the study and provided appropriate management by the investigators.


Other Outcome Measures:
  1. Improvement in pruritus visual analogue scale scores [ Time Frame: Before and after the treatment period of 1 month ]
    The visual analogue scale is a 10-cm long line oriented horizontally or vertically used to indicate the patient's intensity of pruritus by crossing the line at the point the corresponds to the patient's pruritus severity. The patients' pruritus was assessed using the VAS scale in which the patients were instructed to select a point along the 10-cm line for his/her assessment, with "0" meaning no pruritus and "10" meaning the most severe pruritus they can imagine.

  2. potassium hydroxide smear conversion [ Time Frame: Before and after the treatment period of 1 month ]
    Potassium hydroxide mount (KOH) test of the lesions were done before , where in KOH 10% reagent dropped on the skin scales to confirm the presence of fungal infection by microscopic examination.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who were treated or undergoing treatment with topical anti-fungal for 2 weeks or oral anti-fungal 1 month before the study
  2. Patients who were taking other systemic medications such as cytotoxic and immunosuppressive drugs
  3. Patients with known liver disease, kidney dysfunction, hematologic problems (e.g. anemia)
  4. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745183


Sponsors and Collaborators
Philippine Dermatological Society
Investigators
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Principal Investigator: Kathleen E Alpapara, MD Philippine Dermatological Society
Study Director: Belen L Dofitas, MD Philippine Dermatological Society

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications of Results:
Dofitas BL and Non BL., Tinea Imbricata: Case Series on Three Patients in Sarangani, Philippines. Acta Medica Philippina. 44(3). (2010)
Carpio, V , Dofitas, B and Frez, L. (2010). Blekis: Tinea imbricata in Sarangani, Philippines.Unpublished manuscript.

Other Publications:
Hemen, Dave and Ledwani, Lalita. A review on anthraquinones isolated from Cassia species and their applications. Indian Journal of Natural Products and Resources. September 2012. Vol. 3 (3), pp.291-319
Núñez Montoya, S.C., Comini L.R., and Cabrera J.L.. Antimicrobial activity of natural photosensitizing anthraquinones. Science against microbial pathogens: communicating current research and technological advances. Department of Pharmacology. 2011. pp 3-13
Okwu, D.E. and Nnamdi, F.U.Cannabinoid Dronabinol alkaloid with antimicrobial activity from Cassia alata Linn. Der Chemica Sinica. 2011. Vol 2(2): 247-254
Philippine Health Research Board. National Ethical Guidelines for Health Research. 2011.pp 54-58 and 91-96.
National Administrative Order No. 3 " The Revised Guidelines and Prior Informed Consent (FPIC) and Related Processes f 2012"
Duke, James. Duke's Handbook of Medicinal Plants of the Bible. USA: CRC Press, 2007.

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Responsible Party: Philippine Dermatological Society
ClinicalTrials.gov Identifier: NCT03745183     History of Changes
Other Study ID Numbers: PDS_PGH_2017_002
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Philippine Dermatological Society:
tinea imbricata
Senna alata
Additional relevant MeSH terms:
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Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Sennoside A&B
Cathartics
Gastrointestinal Agents