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.: PACTR202310817915957 Date of Approval: 26/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Garcinia kola nuts on erectile dysfunctoion in Yaounde Central Hospital
Official scientific title A new treatment for mild erectile dysfunction: Garcinia kola nuts
Brief summary describing the background and objectives of the trial Erectile dysfunction is defined as the recurrent or persistent inability to obtain and/or maintain an erection sufficient for sexual activity. Bien que le sujet soit tabou dans nos contrées, It is a disease responsible for the deterioration of quality of life, and its prevalence is increasing with the resurgence of metabolic diseases. Phosphodiesterase type-5 inhibitors are first-line therapies for erectile dysfunction. However, the mere mention of this medical treatment in our environment remains a subject of mistrust for men. Traditional local pharmacopoeia offers a wide range of aphrodisiac substances to alleviate erectile dysfunction. Garcinia kola nuts, which are widely consumed in Africa, have been shown to improve libido, erection and ejaculation in rats. These nuts contain numerous bioactive compounds that give them aphrodisiac, antiatherogenic, anti-inflammatory and antioxidant properties. From this point of view, Garcinia kola nuts may represent an affordable, acceptable drug with few or no side-effects for a disease that is becoming increasingly common among young and elderly people alike.The aim of this study was to evaluate the pharmacological efficacy of Garcinia kola nuts in the management of erectile dysfunction.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/06/2023
Actual trial start date 15/06/2023
Anticipated date of last follow up 15/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 40
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Garcinia kola nuts 10 ± 1g bid (6am and 8pm)) 12 weeks Each participant received sufficient treatment for 25 days at each visit, covering the 3-week period between appointments. Participants were encouraged to have at least 2 sexual encounters per week. A schedule of visits has been drawn up and appointments made for the various dates. A total of four appointments were scheduled and between visits telephone calls was made every five days for reminders and follow-up.Each participant was allocated a code. During each visit, parameters were taken, a self-questionnaire, compliance and tolerance sheets were completed by the patient and handed in under seal. 20 Dose Comparison
Experimental Group Garcinia kola nuts 20 ± 1g bid (6am and 8pm) 12 weeks Each participant in each group received sufficient treatment for 25 days at each visit, covering the 3-week period between appointments. Participants were encouraged to have at least 2 sexual encounters per week. A schedule of visits has been drawn up and appointments made for the various dates. A total of four appointments were scheduled and between visits telephone calls was made every five days for reminders and follow-up.Each participant was allocated a code. During each visit, parameters were taken, a self-questionnaire, compliance and tolerance sheets were completed by the patient and handed in under seal. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-All patients over 25 years of age who have had erectile dysfunction for at least 03 months a -All patients who have given their free and informed consent to participate in the study. -Any patient suffering from hypogonadism, prostate cancer or chronic kidney disease was not included in our study. - Any patient who had consumed Garcinia kola nuts or traditional pharmacopoeia in the two weeks prior to inclusion in the study. -Any patient with an unbalanced chronic condition during the study (grade 3 arterial hypertension, unbalanced diabetes: fasting blood glucose >1.8g/l in particular). - Severe intolerance to Garcinia kola nuts during the intervention -Withdrawal of consent to the study Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 75 Year(s) Male
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 23/03/2023 Comite d Ethique et d Assurance Qualite de l Universite des Montagnes
Ethics Committee Address
Street address City Postal code Country
Universite des Montagnes, Banekane, Bangangte Bangangte 206 Cameroon
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 13/03/2023 Autorisation de recherche de l Hopital Central de yaounde
Ethics Committee Address
Street address City Postal code Country
Yaounde II Yaounde 87 Cameroon
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 07/08/2023 National Herbarium
Ethics Committee Address
Street address City Postal code Country
Yaounde Yaounde 1601 Cameroon
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 20/02/2023 Autorisation de recherche
Ethics Committee Address
Street address City Postal code Country
Yaounde Yaounde 812 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome improvement in erectile function (increase in erectile function score of at least 1 point). 3weeks, 6 weeks, 9weeks, 12 weeks
Secondary Outcome The increase in satisfaction with sexual intercourse, orgasm, sexual desire, overall satisfaction and the overall IIEF15 score 3 weeks, 6 weeks, 9 weeks, 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Yaounde Central Hospital Yaounde II Yaounde Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
DJANDJA NJIANG Habib Nikholae Universite des Montagnes, Bangangte Bangangte 206 Cameroon
University of Yaounde I University of Yaounde I Yaounde Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ngameni Bathelemy Yaounde Yaounde Cameroon University
Secondary Sponsor Fouda Pierre Joseph Yaounde Yaounde Cameroon Hospital
COLLABORATORS
Name Street address City Postal code Country
National Herbarium Yaounde Yaounde Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Habib Nikholae DJANDJA NJIANG hnikholae@gmail.com 00237673074354 Banekane
City Postal code Country Position/Affiliation
Bangangte Cameroon Universite des Montagnes
Role Name Email Phone Street address
Public Enquiries Landry Oriole Mbouche landrymbouche@gmail.com 00237699881526 Yaounde
City Postal code Country Position/Affiliation
Yaounde Cameroon Faculty of Medicine and Biomedical Sciences of the University of Yaounde I
Role Name Email Phone Street address
Scientific Enquiries Bathelemy Ngameni bath_ngameni@yahoo.fr 00237690230281 Yaounde
City Postal code Country Position/Affiliation
Yaounde Cameroon Faculty of Medicine and Biomedical Sciences of the University of Yaounde I
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Anyone who wishes to access the 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