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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202311887239866 Date of Registration: 09/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title DBU_SafeHerb
Official scientific title Phase I Clinical Trial for Evaluation of Rosmarinus officinalis, Thymus schimperi, Eucalyptus globulus, Cymbopogon citratus and Lavandula angustifolia on healthy human skin
Brief summary describing the background and objectives of the trial Introduction: ‘Ankober Project’ was founded in 2010 at Debre Berhan University. It was established to conduct research on traditionally used herbal medicinal plants. Scientific screening of traditional medicinal plant is a timely endeavor to make use of the research outputs to address primary healthcare problems in the study area. So far, the team has done antimicrobial activity tests of herbal oils extracted from medicinal plants and safety evaluations of the extracts on experimental animals. Promising data for antimicrobial activities of oils of Rosmarinus officinalis, Thymus schimperi, Eucalyptus globulus, Cymbopogon citratus and Lavandula angustifolia against bacteria and fungi were obtained. Acute and sub acute oral toxicity studies with these five medicinal plants on albino mice showed the safety nature of the oils. The skin irritation tests performed on wistar rats also showed no toxic potential. Based on these data, safe concentration of herbal ointment will be selected to evaluate its safety profile on healthy human skin. Objective: To evaluate the safety of herbal ointments on healthy human skin.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) SafeHerb
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Bacterial skin infections
Purpose of the trial Treatment: Drugs
Anticipated trial start date 06/11/2023
Actual trial start date
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Single Group Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group herbal ointment finger tip 14 days follow up The investigational products were prepared from herbs to be used for bacterial skin infection. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Healthy volunteers without skin diseases or any other diseases (acute or chronic) from both sexes • Available for follow-up observations during the clinical trial period • Willing to avoid using topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial • A history of adverse reactions to adhesive tape • Participants with hypersensitive skin; skin abnormalities, such as severe acne, erythema, or telangiectasia at the test site • Participants who use the same or similar cosmetics (or pharmaceuticals) on the test site within three months • Those who have undergone a skin peeling or having wrinkles removed within six months of the interview Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 29/08/2023 AAERC
Ethics Committee Address
Street address City Postal code Country
Jimma Road, ALERT COMPOUND Addis Ababa 1005 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome safety of the herbal ointments 14 days follow up.
Secondary Outcome 1. Incidence and severity of treatment emergent adverse events 2. Incidence and magnitude of treatment emergent laboratory abnormalities 3. Changes from baseline on skin irritation assessment scores after treatment. 14 days follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Armauer Hansen Research Institute Jimma Road Addis Ababa 1005 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Goverment Debre Berhan Debre Berhan Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Debre Berhan University Debre Berhan Debre Berhan Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adamu Bayissa Kiltu adamu.bayiisa@ahri.gov.et +251929041898 Asko
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Armauer Hansen Research Institute
Role Name Email Phone Street address
Public Enquiries Melat Gebremedhin Teklewolde melatgebremedhin5@gmail.com +251936960547 Bole
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Armauer Hansen Research Institute
Role Name Email Phone Street address
Scientific Enquiries Mekonnen Teferi Mekonnen mekonnen.tefrei@ahri.gov.et +251911103233 Jemo Michael
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Armauer Hansen Research Institute
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data generated in this study belongs to the study group as a whole. The final database will be shared amongst the site PI and key members of the research team. The deidentified database may be shared with researchers not directly involved in this study but only after the main paper has been published and in accordance with AHRI guidelines on data sharing. The database will only be shared if future publications are not compromised. Clinical Study Report one year after the end of the study Researchers who want the study data
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