Raw, Unadulterated African Honey for Ulcer Healing in Leprosy: Protocol for the Honey Experiment on Leprosy Ulcer (HELP) Randomized Controlled Trial.
Africa
RCT
honey
leprosy
nerves
neuropathy
randomized controlled trial
ulcers
wounds
Journal
JMIRx med
ISSN: 2563-6316
Titre abrégé: JMIRx Med
Pays: Canada
ID NLM: 101776650
Informations de publication
Date de publication:
01 Mar 2024
01 Mar 2024
Historique:
received:
18
07
2023
revised:
27
12
2023
accepted:
13
01
2024
medline:
15
3
2024
pubmed:
15
3
2024
entrez:
15
3
2024
Statut:
epublish
Résumé
Leprosy leads to nerve damage and slow-healing ulcers, which are treatable with routine therapy. There has been a recent resurgence of interest in the use of honey for the treatment of different kinds of wounds. The aim of this study, Honey Experiment on Leprosy Ulcer (HELP), is to evaluate the healing properties of raw, unadulterated African honey in comparison with normal saline dressing for the treatment leprosy ulcers. This is a multicenter, comparative, prospective, single-blinded, parallel-group, and 1:1 individually randomized controlled trial to be conducted at The Leprosy Referral Hospital, Chanchaga in Minna, Niger State, North Central Nigeria, and St. Benedict Tuberculosis and Leprosy Rehabilitation Hospital in Ogoja, Cross River State, South-South Nigeria. Raw, unadulterated honey will be used in the ulcer dressing of eligible, consenting participants in the intervention group, whereas those in the control group will be treated by dressing with normal saline. The main outcomes will be the proportion of complete healing and the rate of healing up to 84 days after randomization. Follow-up will be conducted 6 months after randomization. We aim to enroll 90-130 participants into the study. Blinded observers will examine photographs of ulcers to determine the outcomes. The recruitment of trial participants began on March 14, 2022, and has been continuing for approximately 24 months. Our study will provide an unbiased estimate of the effect of honey on the healing of neuropathic ulcers.
Sections du résumé
Background
UNASSIGNED
Leprosy leads to nerve damage and slow-healing ulcers, which are treatable with routine therapy. There has been a recent resurgence of interest in the use of honey for the treatment of different kinds of wounds.
Objective
UNASSIGNED
The aim of this study, Honey Experiment on Leprosy Ulcer (HELP), is to evaluate the healing properties of raw, unadulterated African honey in comparison with normal saline dressing for the treatment leprosy ulcers.
Methods
UNASSIGNED
This is a multicenter, comparative, prospective, single-blinded, parallel-group, and 1:1 individually randomized controlled trial to be conducted at The Leprosy Referral Hospital, Chanchaga in Minna, Niger State, North Central Nigeria, and St. Benedict Tuberculosis and Leprosy Rehabilitation Hospital in Ogoja, Cross River State, South-South Nigeria. Raw, unadulterated honey will be used in the ulcer dressing of eligible, consenting participants in the intervention group, whereas those in the control group will be treated by dressing with normal saline. The main outcomes will be the proportion of complete healing and the rate of healing up to 84 days after randomization. Follow-up will be conducted 6 months after randomization. We aim to enroll 90-130 participants into the study. Blinded observers will examine photographs of ulcers to determine the outcomes.
Results
UNASSIGNED
The recruitment of trial participants began on March 14, 2022, and has been continuing for approximately 24 months.
Conclusions
UNASSIGNED
Our study will provide an unbiased estimate of the effect of honey on the healing of neuropathic ulcers.
Identifiants
pubmed: 38488451
pii: v5i1e50970
doi: 10.2196/50970
pmc: PMC11024902
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e50970Informations de copyright
© Sunday Udo, Pius Ogbu Sunday, Paul Alumbugu Tsaku, Israel Olaoluwa Oladejo, Anthony Meka, Linda Chinonso Ugwu, Motunrayo Ajisola, Joshua Akinyemi, Abiola Oladejo, Akinyinka Omigbodun, Sopna Mannan Choudhury, Jo Sartori, Onaedo Ilozumba, Sam Watson, Richard Lilford. Originally published in JMIRx Med (https://med.jmirx.org).
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