Raw, Unadulterated African Honey for Ulcer Healing in Leprosy: Protocol for the Honey Experiment on Leprosy Ulcer (HELP) Randomized Controlled Trial

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

doi:10.2196/50970

Raw, Unadulterated African Honey for Ulcer Healing in Leprosy: Protocol for the Honey Experiment on Leprosy Ulcer (HELP) Randomized Controlled Trial

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

^*Corresponding author for this work

Applied Health Research

Research output: Contribution to journal › Review article › peer-review

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Abstract

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.

Trial Registration: ISRCTN registry ISRCTN10093277; https://www.isrctn.com/ISRCTN10093277

Original language	English
Article number	e50970
Number of pages	11
Journal	JMIRx Med
Volume	5
DOIs	https://doi.org/10.2196/50970
Publication status	Published - 1 Mar 2024

Bibliographical note

Acknowledgments:
We acknowledge the contribution of the Public Health Department of the Niger State Ministry of Health and The Leprosy Referral Hospital, Chanchaga to the clinical trial. We also acknowledge members of the communities affected with leprosy in Nigeria for their assurance of cooperation during pretrial engagements. We thank the chair and members of the Trial Steering Committee—Dr Doyin Odubanjo, Professor Kara Hanson, Dr Paul Saunderson, and Dr Jerry Joshua—for their constructive advice on the trial. We also acknowledge the support of Dr Indra Napit, Dilip Shrestha, Karuna Neupane, and Anjali Shrivastav from The Leprosy Mission Nepal for their support in training for the trial. This research was funded by the National Institute for Health Research (NIHR: 200132) using UK aid from the UK government to support global health research. The views expressed in this publication are those of the authors and not necessarily those of the NIHR or the UK Department of Health and Social Care. The funders of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the manuscript.

Keywords

leprosy
Ulcers
wounds
neuropathy
nerves
Africa
randomised controlled trial
RCT

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Udo, S., Ogbu Sunday, P., Alumbugu Tsaku, P., Olaoluwa Oladejo, I., Meka, A., Chinonso Ugwu, L., Ajisola, M., Akinyemi, J., Oladejo, A., Omigbodun, A., Choudhury, S. M., Sartori, J., Ilozumba, O., Watson, S., & Lilford, R. (2024). Raw, Unadulterated African Honey for Ulcer Healing in Leprosy: Protocol for the Honey Experiment on Leprosy Ulcer (HELP) Randomized Controlled Trial. JMIRx Med, 5, Article e50970. https://doi.org/10.2196/50970

@article{ce3580c4359c4e96bba1eadbe51a65f7,

title = "Raw, Unadulterated African Honey for Ulcer Healing in Leprosy: Protocol for the Honey Experiment on Leprosy Ulcer (HELP) Randomized Controlled Trial",

abstract = "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. Trial Registration: ISRCTN registry ISRCTN10093277; https://www.isrctn.com/ISRCTN10093277",

keywords = "leprosy, Ulcers, wounds, neuropathy, nerves, Africa, randomised controlled trial, RCT",

author = "Sunday Udo and {Ogbu Sunday}, Pius and {Alumbugu Tsaku}, Paul and {Olaoluwa Oladejo}, Israel and Anthony Meka and {Chinonso Ugwu}, Linda and Motunrayo Ajisola and Joshua Akinyemi and Abiola Oladejo and Akinyinka Omigbodun and Choudhury, {Sopna Mannan} and Jo Sartori and Onaedo Ilozumba and Sam Watson and Richard Lilford",

note = "Acknowledgments: We acknowledge the contribution of the Public Health Department of the Niger State Ministry of Health and The Leprosy Referral Hospital, Chanchaga to the clinical trial. We also acknowledge members of the communities affected with leprosy in Nigeria for their assurance of cooperation during pretrial engagements. We thank the chair and members of the Trial Steering Committee—Dr Doyin Odubanjo, Professor Kara Hanson, Dr Paul Saunderson, and Dr Jerry Joshua—for their constructive advice on the trial. We also acknowledge the support of Dr Indra Napit, Dilip Shrestha, Karuna Neupane, and Anjali Shrivastav from The Leprosy Mission Nepal for their support in training for the trial. This research was funded by the National Institute for Health Research (NIHR: 200132) using UK aid from the UK government to support global health research. The views expressed in this publication are those of the authors and not necessarily those of the NIHR or the UK Department of Health and Social Care. The funders of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the manuscript.",

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month = mar,

day = "1",

doi = "10.2196/50970",

language = "English",

volume = "5",

journal = "JMIRx Med",

}

Udo, S, Ogbu Sunday, P, Alumbugu Tsaku, P, Olaoluwa Oladejo, I, Meka, A, Chinonso Ugwu, L, Ajisola, M, Akinyemi, J, Oladejo, A, Omigbodun, A, Choudhury, SM, Sartori, J, Ilozumba, O , Watson, S & Lilford, R 2024, 'Raw, Unadulterated African Honey for Ulcer Healing in Leprosy: Protocol for the Honey Experiment on Leprosy Ulcer (HELP) Randomized Controlled Trial', JMIRx Med, vol. 5, e50970. https://doi.org/10.2196/50970

TY - JOUR

T1 - Raw, Unadulterated African Honey for Ulcer Healing in Leprosy

T2 - Protocol for the Honey Experiment on Leprosy Ulcer (HELP) Randomized Controlled Trial

AU - Udo, Sunday

AU - Ogbu Sunday, Pius

AU - Alumbugu Tsaku, Paul

AU - Olaoluwa Oladejo, Israel

AU - Meka, Anthony

AU - Chinonso Ugwu, Linda

AU - Ajisola, Motunrayo

AU - Akinyemi, Joshua

AU - Oladejo, Abiola

AU - Omigbodun, Akinyinka

AU - Choudhury, Sopna Mannan

AU - Sartori, Jo

AU - Ilozumba, Onaedo

AU - Watson, Sam

AU - Lilford, Richard

N1 - Acknowledgments: We acknowledge the contribution of the Public Health Department of the Niger State Ministry of Health and The Leprosy Referral Hospital, Chanchaga to the clinical trial. We also acknowledge members of the communities affected with leprosy in Nigeria for their assurance of cooperation during pretrial engagements. We thank the chair and members of the Trial Steering Committee—Dr Doyin Odubanjo, Professor Kara Hanson, Dr Paul Saunderson, and Dr Jerry Joshua—for their constructive advice on the trial. We also acknowledge the support of Dr Indra Napit, Dilip Shrestha, Karuna Neupane, and Anjali Shrivastav from The Leprosy Mission Nepal for their support in training for the trial. This research was funded by the National Institute for Health Research (NIHR: 200132) using UK aid from the UK government to support global health research. The views expressed in this publication are those of the authors and not necessarily those of the NIHR or the UK Department of Health and Social Care. The funders of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the manuscript.

PY - 2024/3/1

Y1 - 2024/3/1

N2 - 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. Trial Registration: ISRCTN registry ISRCTN10093277; https://www.isrctn.com/ISRCTN10093277

AB - 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. Trial Registration: ISRCTN registry ISRCTN10093277; https://www.isrctn.com/ISRCTN10093277

KW - leprosy

KW - Ulcers

KW - wounds

KW - neuropathy

KW - nerves

KW - Africa

KW - randomised controlled trial

KW - RCT

U2 - 10.2196/50970

DO - 10.2196/50970

M3 - Review article

VL - 5

JO - JMIRx Med

JF - JMIRx Med

M1 - e50970

ER -

Raw, Unadulterated African Honey for Ulcer Healing in Leprosy: Protocol for the Honey Experiment on Leprosy Ulcer (HELP) Randomized Controlled Trial

Abstract

Bibliographical note

Keywords

UN SDGs

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