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.: PACTR202003714748946 Date of Approval: 16/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Efficacy of topical Capsaicin in the management of painful diabetic peripheral neuropathy: A unicenter double-blind, randomized clinical trial
Official scientific title The Efficacy of topical Capsaicin in the management of painful diabetic peripheral neuropathy: A unicenter double-blind, randomized clinical trial
Brief summary describing the background and objectives of the trial Painful peripheral neuropathy is a common complication of diabetes and its management is difficult. Neurotropic drugs, which are the drugs of choice, have moderate efficacy due to high first pass metabolism. Topical Capsaicin, derived from the capsicum plant, is effective in relieving the pain of diabetic peripheral neuropathy in Caucasians. Due to an intercultural bias in pain treatment response, we evaluated the efficacy of Capsaicin on painful diabetic neuropathy in sub-Saharan subjects.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 04/12/2017
Actual trial start date 01/01/2018
Anticipated date of last follow up 06/03/2020
Actual Last follow-up date 20/04/2018
Anticipated target sample size (number of participants) 22
Actual target sample size (number of participants) 22
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Capsaicin group Capsaicin 0.075% gel in no-label white tubes, was dispensed to patient according to randomized group assignment. Participants applied the drug topically on the feet 3 times daily. 8 weeks Experimental group 11
Control Group Miconazole group Miconazole cream, in identical no-label white tubes were dispensed to patient according to randomized group assignment. Participants applied the drug topically on the feet 3 times daily 8 weeks Control group 11 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All were patients with type 2 diabetes who had daily pain or painful paresthesias in a neuropathic or radiculopathic distribution, intensity between 4 and 7 on a visual analogic scale, interfering with daily activities, work or sleep for at least 3 months duration. • History of allergies to any capsaicin product • Diabetic patients with other diagnosed etiology responsible for peripheral neuropathy such as hepatitis, AIDS, Nutritional deficiencies (folate, vitamin B12) • Presence of open skin lesions at the site of application of the study medication • Signs of infection on limbs or amputations • Pregnant or lactating females • Subjects with other topical medication at site of application of study cream. • All eligible patients who did not give their signed informed consent to participate Middle Aged: 45 Year(s)-64 Year(s) 38 Year(s) 66 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 11/01/2018 Center Regional Ethics Committee for Human Health Research
Ethics Committee Address
Street address City Postal code Country
Province Yaounde 00237 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reduction in the mean pain score from baseline, as assessed by the Visual analogic scale (0-10 points). Every 2 weeks
Secondary Outcome the level of improvement in quality of life score after intervention. at the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Obesity Center Education street Yaounde Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal Investigator Mouankeu Bafang Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor AsacPharma laboratories Cameroon Emombo 2 Yaounde 00237 Cameroon Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dehayem Mesmin Melen Yaounde 00237 Cameroon
Martine Claude Etoa Etoga Melen Yaounde 00237 Cameroon
Dayawa Da Agoons Harrisburg Pennsylvania United States of America
Yepnjio Faustin Melen Yaounde Cameroon
Boli Ongmeb Anne Melen Yaounde Cameroon
Jean Claude Katte Melen Yaounde Cameroon
Yves Florent Wasnyo Melen Yaounde Cameroon
Ngassam Tcheundjio Eliane Stella Melen Yaounde Cameroon
Nkamgna Ariane Melen Yaounde Cameroon
Eugene Sobngwi Melen Yaounde Cameroon
Mbanya Jean Claude Melen Yaounde Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Batakeh Agoons bbagoons@gmail.com 00237678616372 Mouankeu
City Postal code Country Position/Affiliation
Bafang Cameroon Doctor
Role Name Email Phone Street address
Public Enquiries Mesmin Dehayem ydeyahem@yahoo.com 00237674685006 Melen
City Postal code Country Position/Affiliation
Yaounde Cameroon Doctor
Role Name Email Phone Street address
Scientific Enquiries Eugene Sobngwi sobngwieugene@yahoo.fr 00237675088750 Melen
City Postal code Country Position/Affiliation
Yaounde Cameroon Proffessor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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