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.: PACTR201505001128346 Date of Registration: 01/05/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Male enhancement nutraceuticals evaluation in Egypt
Official scientific title Clinical efficacy and safety of products marketed in Egypt under the claim of being natural nutraceuticals for male enhancement
Brief summary describing the background and objectives of the trial Comparative, Randomized, Single dose, Double-blind, Cross-over study to compare the clinical efficacy and safety of products marked in Egypt under the claim of being natural nutraceuticals for male enhancement such as Tiger King, Hercules, Natural Viagra, Plant Viagra, and Herbal Viagra with Viagra® (Sildenafil tablet, Pfizer), Levitra® (Vardenafil tablet, Bayer), and Cialis® (Tadalafil tablet. Lilly USA) after oral administration on healthy volunteers The main objective is the investigation of the clinical efficacy and safety of products marked in Egypt under the claim of being natural nutraceuticals for male enhancement
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SEET
Disease(s) or condition(s) being studied Erectile Dysfunction
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/09/2014
Actual trial start date 01/09/2014
Anticipated date of last follow up 01/03/2015
Actual Last follow-up date 01/03/2015
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 16
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
Crossover: all participants receive all interventions in different sequence during study Randomised Stratified allocation where factors as; Healthy, Male, Age (30 to 60 yrs), volunteers used in the stratification sealed opaque bags Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Viagra® 50 mg tablets (Sildenafil citrate, Pfizer, USA) once weekly 6 months Phosphodiestrase 5 Inhibitors 16 Active-Treatment of Control Group
Control Group Levitra® 20 mg tablets (Vardenafil HCL, Bayer, Germany) once weekly 6 months Phosphodiestrase 5 Inhibitors 9 Active-Treatment of Control Group
Control Group Cialis® 20 mg tablets (Tadalafil HCL, Eli Lilly, USA) once weekly 6 months Phosphodiestrase 5 Inhibitors 7 Active-Treatment of Control Group
Control Group Starch tablets locally compressed (Erweka Benchtop tablet machine EK 0 / AR 400, Hamburg, Germany) once weekly 6 months Placebo 13 Placebo
Experimental Group Tiger King once weekly 6 months claimed nutraceutical 16
Experimental Group Hercules once weekly 6 months claimed nutraceutical 16
Experimental Group Herbal Viagra once weekly 6 months claimed nutraceutical 16
Experimental Group Natural viagra once weekly 6 months claimed nutraceutical 16
Experimental Group Plant Viagra once weekly 6 months claimed nutraceutical 16
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy married volunteers Hypertension Diabetes Cardiovascular disease Liver diseases Kidney diseases 30 Year(s) 60 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 15/08/2014 Research Ethics Committee, Faculty of Pharmacy, Alexandria University
Ethics Committee Address
Street address City Postal code Country
1 El-Kartum Square Alexandria 21521 Egypt
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 15/08/2014 Research Ethics Committee, Faculty of Pharmacy, Alexandria University
Ethics Committee Address
Street address City Postal code Country
1 El-Kartum Square Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Concentration of drug in blood 2 to 6 hours post dose
Primary Outcome Liver and Kidney functions 1 month before the study 1 month after the study
Primary Outcome Blood pressure 1 hour pre-dose 2 hours post-dose 24 hours post-dose
Primary Outcome Questionnaire; safety and efficacy assessment 2 hours post-dose completed 24 hours post-dose
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University, Faculty of Pharmacy 1 El-Kartum Square Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded 1 El-Kartum Square Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Pharmacy, Alexandria university 1 El-Kartum Square Alexandria 21521 Egypt University
Primary Sponsor Mohamed Nounou 1 El-Kartum Square Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ola El Gaddar Al Ibrahimeyah Qebli WA Al Hadrah Bahri Alexandria 21515 Egypt
Ghada ElAgouri 1 El-Kartum Square Alexandria 21521 Egypt
Ola El Gaddar 165, Horreya Avenue, Hadara Alexandria 21561 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Nounou mohamed.nounou@alexu.edu.eg +2 012 21444930 1 El-Kartum Square
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer of pharmaceutics
Role Name Email Phone Street address
Principal Investigator Ahmed Eshra eshraahmed40@yahoo.com +2 100 9726003 1 El-Kartum Square
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Pharmaceutics
Role Name Email Phone Street address
Principal Investigator Ghada ElAgouri ghadaelhadad2014@gmail.com +2 011 25719058 1 El-Kartum Square
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt
Role Name Email Phone Street address
Public Enquiries Ahmed Othman Ahmed.Othman@gmail.com 0100 4344084 1 El-Kartum Square
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Study Coordinator
Role Name Email Phone Street address
Scientific Enquiries Ola ElGaddar Ola.Elgaddar@alexu.edu.eg +2 0100 6073883 165 El-Horreya Avenue, El-Hadra
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Chemical Pathologist
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information