02711nas a2200409 4500000000100000008004100001260001200042653001100054653000800065653001000073653001200083653001100095653001500106653003200121653001100153653001100164100001000175700001300185700001200198700001400210700001100224700001100235700001400246700001500260700001400275700001600289700001600305700001400321700001500335700001300350700001400363245015400377856004000531490000600571520171000577022001402287 2024 d c03/202410aAfrica10aRCT10aHoney10aleprosy10aNerves10aNeuropathy10arandomized controlled trial10aUlcers10aWounds1 aUdo S1 aSunday P1 aTsaku P1 aOladejo I1 aMeka A1 aUgwu L1 aAjisola M1 aAkinyemi J1 aOladejo A1 aOmigbodun A1 aChoudhury S1 aSartori J1 aIlozumba O1 aWatson S1 aLilford R00aRaw, Unadulterated African Honey for Ulcer Healing in Leprosy: Protocol for the Honey Experiment on Leprosy Ulcer (HELP) Randomized Controlled Trial. uhttps://xmed.jmir.org/2024/1/e509700 v53 a

Background: 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: 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: 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: The recruitment of trial participants began on March 14, 2022, and has been continuing for approximately 24 months.

Conclusions: Our study will provide an unbiased estimate of the effect of honey on the healing of neuropathic ulcers.

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