Udo Sunday, Ogbu Sunday Pius, Tsaku Paul Alumbugu, Oladejo Israel Olaoluwa, Meka Anthony, Ugwu Linda Chinonso, Ajisola Motunrayo, Akinyemi Joshua, Oladejo Abiola, Omigbodun Akinyinka, Choudhury Sopna Mannan, Sartori Jo, Ilozumba Onaedo, Watson Sam, Lilford Richard
The Leprosy Mission Nigeria, Abuja, Nigeria.
German Leprosy and TB Relief Association/RedAid Nigeria, Enugu, Nigeria.
JMIRx Med. 2024 Mar 1;5:e50970. doi: 10.2196/50970.
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.
麻风病会导致神经损伤和愈合缓慢的溃疡，常规治疗方法可对其进行治疗。最近，人们对使用蜂蜜治疗各种伤口的兴趣再度兴起。
本研究“蜂蜜治疗麻风溃疡实验（HELP）”旨在评估未经掺杂的天然非洲蜂蜜与生理盐水敷料相比，在治疗麻风溃疡方面的愈合特性。
这是一项多中心、比较性、前瞻性、单盲、平行组且1:1个体随机对照试验，将在尼日利亚中北部尼日尔州明纳的钱查加麻风转诊医院以及尼日利亚南南地区克罗斯河州奥戈贾的圣本笃结核病和麻风康复医院进行。未经掺杂的天然蜂蜜将用于干预组符合条件且同意参与的参与者的溃疡敷料，而对照组的参与者将用生理盐水敷料进行治疗。主要结局将是完全愈合的比例以及随机分组后84天内的愈合率。随机分组6个月后进行随访。我们的目标是招募90 - 130名参与者进入该研究。 blinded观察员将检查溃疡照片以确定结局。
试验参与者的招募于2022年3月14日开始，并且已经持续了大约24个月。
我们的研究将对蜂蜜对神经性溃疡愈合的效果提供无偏估计。
