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Ulcer Plants: Highly Accessible Plant Antiseptics for Use in Remote Areas of PNG

NCT06690814 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2024-11-29

No results posted yet for this study

Summary

Small cutaneous ulcers are common in Papua New Guinea but are normally left untreated due to lack of easy access to basic medicines. The goal of this clinical trial is to test the efficacy of three readily available antibacterial plant medicines, Ficus septica, Pterocarpus indicus and Curcuma longa, comparing healing outcomes to control arms receiving Savlon antiseptic cream or no treatment. Participants with cutaneous ulcers less than 1cm in diameter will be randomized to receive topical treatment with one of three different plant medicines, Savlon cream or no treatment treatment and followed up at day 7 and 14 to assess ulcer healing and ulcer surface area.

Conditions

  • Cutaneous Ulcer Disease
  • Skin Sores

Interventions

OTHER

Ficus septica exudate (antiseptic plant exudates)

F. septica sap contains the antibacterial alkaloid ficuseptine which exhibits activivity agaisnt S. pyogenes and H. ducreyi, two pàthogens associated with cutaneous ulcer disease in Papau New Guinea. The sap has been tested using the Ames test for mutagenesis, and found to be non-mutagenic; testing was carried out by toxicology service provider Gentronix, UK (results available separately on request).

OTHER

Pterocarpus indicus exudate

P. indicus sap exhibits antibacterial activivity agaisnt S. pyogenes, a pàthogen associated with cutaneous ulcer disease in Papau New Guinea. The sap has been tested using the Ames test for mutagenesis, and found to be non-mutagenic; testing was carried out by toxicology service provider Gentronix, UK (results available separately on request).

OTHER

Curcuma longa aqueous extract

C. longa is a culinary herb that contains the antibatieral compound curcumin. Curcumin exhibits antibacterial activity agasint S. pyogenes and has profound effects on bacterial biofilms. This intervention uses a mulch of the rhizome that has been sqeeezed to produce a curcumin containing aqueous fluid.

DRUG

Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)

Common over the counter antiseptic cream

Sponsors & Collaborators

  • The Royal Botanic Gardens, Kew

    collaborator UNKNOWN

  • Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-04
Primary Completion
2024-11-01
Completion
2024-11-01

Countries

  • Papua New Guinea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06690814 on ClinicalTrials.gov