Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901905832601 Date of Approval: 17/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Neem and coconut oil for treatment of tungiasis
Official scientific title Phase IIa, randomised controlled trial of a locally-made, herbal remedy (neem & coconut oil) for treatment of jiggers (Tunga penetrans).
Brief summary describing the background and objectives of the trial Tungiasis, a parasitic skin disease (sand flea disease) inflicts pain and suffering on millions of people in Sub-Saharan Africa and South America, and yet it gets little attention from donors, scientists, governments and even health workers. There is no highly effective, widely available, safe and simple treatment. Instead communities in their desperation remove the embedded fleas using unsterilized pins and plant thorns which carry huge risk of secondary infection with bacteria and possibly even HIV and Hepatitis B. The government of Kenya currently recommends the use of potassium permanganate and Vaseline, but this has been demonstrated in a recent trial to have only 39% efficacy. Some communities use their own herbal remedies for sand flea control. In Kilifi County, a mix of natural products based mostly on neem oil (Azadirachta indica),) and coconut oil (Cocos nucifera). Coconut oil is widely used in the food and cosmetics industry and neem oil as an antiseptic, and used for medical and agricultural insect control. Their safety and beneficial properties have been shown in various contexts. Primary Objective: To determine whether a mix of neem and coconut oils kills a higher proportion of embedded jiggers than the current standard of potassium permanganate and Vaseline, in 7 days. Secondary Objectives: ¿ To determine whether neem and coconut oil reduces inflammation, pain and itching better than the standard treatment, in 7 days. ¿ To determine the safety of the neem and coconut oil mix for topical use.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Tungiasis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 23/01/2018
Actual trial start date 23/01/2018
Anticipated date of last follow up 22/05/2018
Actual Last follow-up date 22/05/2018
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 96
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Non-SSC Protocol No. 514, 1st April 2016: Kenya Medical Research Institute-Scientific & Ethical Research Unit
PPB/ECCT/16/05/03/2016(94) Kenya Pharmacy and Poisons Board, Expert Committee on Clinical Trials
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization. At the start of each day of enrollment the first case selected a card from an envelope to determine treatment. All others on that day received alternate treatment option. Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Neemcoco drops directly on embedded fleas, on Day 1 and 3 of trial participation. once topical oil applied directly to the affected areas of skin. 50 Active-Treatment of Control Group
Control Group Potassium Permanganate 0.1% on Day 1 only 15 minutes, once footbath 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Children age 6-14 years, both male and female. ¿ With one or two viable, embedded sand flea of stage IIa-IIIa of the Fortaleza classification, on both feet. ¿ Availability of a caregiver over the age of 18 years to sign the consent forms Less than 6 years or older than 14 years. Patients with the presence of gross inflammation, abscess or ascending lymphangitis or lymphedema on either foot Refusal of parent or child to participate. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 6 Year(s) 14 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/11/2017 Kenya Medical Research Institute Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Mbagathi Road Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of viable embedded sand fleas which lose viability signs after seven days of follow-up. Embedded fleas observed for viability signs on Day 1, 3, 5 and 7.
Secondary Outcome abnormal development of the embedded sand flea; no increase in size, discolouring or desiccation of the abdominal rear cone. Day 1, 3, 5 & 7
Secondary Outcome ¿ the proportion of study subjects with reduced inflammation Day 1, 3 5 & 7
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dabaso Tujengane Dabaso Turtle Bay Road Watamu 80202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
German Doctors Peter Wychodil Bonn Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ulrike Fillinger Thomas Odhiambo Campus, ICIPE Mbita Kenya University
COLLABORATORS
Name Street address City Postal code Country
Patrick Sawa ICIPE Mbita Kenya
Lynne Elson Dabaso Tujengane Watamu 80202 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ulrike Fillinger ufillinger@icipe.org 00254-721-841452 ICIPE
City Postal code Country Position/Affiliation
Mbita Kenya Acting Director Human Health
Role Name Email Phone Street address
Public Enquiries Lynne Elson lynne.elson@gmail.com 254 729 338457 P.O. Box 770
City Postal code Country Position/Affiliation
Watamu 80202 Kenya
Role Name Email Phone Street address
Scientific Enquiries Lynne Elson lynne.elson@gmail.com 254 729 338457 P.O. Box 770
City Postal code Country Position/Affiliation
Watamu 80202 Kenya
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Excel spread sheet of original anonymized data will be deposited on an open-access research data sharing platform, including (1) Background data, (2) Parasitological assessments, (3) Clinical assessment. Informed Consent Form,Statistical Analysis Plan,Study Protocol The data will be available with the publication of the results, expected latest by December 2019. Open access, no restrictions
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information