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.: PACTR201606001665364 Date of Approval: 06/06/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title VCO Trial
Official scientific title A Double-blind Randomized Trial on the Effectiveness of Syferol - IHP® (A Special Blend of Virgin Coconut Oil and Cold-Pressed Ocimum sanctum Oil) for the Treatment of Peptic Ulcer Disease
Brief summary describing the background and objectives of the trial Peptic ulcer disease (PUD), a gastrointestinal disease affecting mainly the stomach and duodenum, arises from the necrotizing effects of certain ulcerogenic agents such as bacterium Helicobacter pylori, non-steroidal anti-inflammatory drugs (NSAIDS) and alcohol. These agents may cause an increase in the levels of acid production or disrupt the integrity of the mucosal walls of the stomach or intestines, thereby exposing them to the acid attack. This disease has continued to be a focus of interest among researchers in the field of medicinal chemistry. Conventionally available and accepted therapies for management of PUD a vast array of noxious side effects, which are pronounced when used in combination. These include antibiotic-associated diarrhea or mild nausea. Serious adverse events such as Clostridium difficile associated colitis, is uncommon. Ulcers can recur and become chronic problems, or can lead to a number of serious complications including bleeding. Prompt treatment is noteworthy. SYFEROL IHP®, produced by Bioresource Development group, Nigeria, is a special blend of Virgin Coconut oil and cold-pressed Ocimum Sanctum oil, which anecdotal report has shown that it is very effective in treatment of patients with peptic ulcer disease. To the best of our knowledge, no prior RCT has been carried out comparing Syferol ¿ IHP® (Bioresource Development Group, Nigeria) and triple peptic ulcer therapy in patients with PUD. The aim of this study is to determine the efficacy and safety of Syferol - IHP® versus triple peptic ulcer therapy on adult patients with peptic ulcer disease.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Peptic Ulcer disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 03/10/2016
Actual trial start date 29/12/2016
Anticipated date of last follow up 31/03/2017
Actual Last follow-up date 31/08/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Randomised Simple randomisation using a radomisation table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SYFEROL IHP® 20mls three times daily 4 weeks SYFEROL IHP®, Bioresource Development group, Nigeria (a special blend of Virgin Coconut oil and cold-pressed Ocimum Sanctum) and the placebo will consist of liquid preparations packaged in identical opaque bottles. Therapy is given orally daily for 4 weeks. 30
Experimental Group Triple therapy twice daily four weeks Patients will receive Esomeprazole 20 mg bd; Amoxicillin 1g bd; and Clarithromycin 500mg bd, all for 2 weeks. Subsequently, only Esomeprazole 20mg bd for another 2 weeks.They will also receive SYFEROL IHP® placebo 20 mls trice daily for 4 weeks 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Both male and female individuals aged between 18-60 years. Patients with confirmed diagnosis of peptic ulcer disease. Patients with normal liver function tests, renal function tests and hematological profiles will be included. Patients refusal of consent to the study Pregnancy. Patients falling outside the age bracket of 18-60 years. 18 Year(s) 60 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 01/07/2016 NAUTH ETHICAL COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Nnewi onitsha road nnewi nnewi 435001 Nigeria
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 01/08/2016 Chukwuemeka odumegwu Ojukwu University Teaching Hospital, Awka
Ethics Committee Address
Street address City Postal code Country
awka awka Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome number of patients with negative urea breath test and/or healing of ulcer at endoscopy At least four weeks after end of therapy.
Secondary Outcome presence of adverse events (such as diarrhea, nausea, vomiting and colitis) During four weeks of therapy.
Secondary Outcome abnormal renal function (serum electrolyte, urea and creatinine) Four weeks of stopping therapy
Secondary Outcome abnormal liver function tests Four weeks of stopping therapy
Secondary Outcome abnormal hematological profile parameters Four weeks of stopping therapy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital, Nnewi. nnewi onisha road, nnewi NNEWI 435001 Nigeria
Chukwu emeke Odumegwu Ojukwu University Teaching Hospital awka Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Bioresource Development group Central Area Abuja Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof Maurice Iwu Abuja Abuja Nigeria Charities/Societies/Foundation
Secondary Sponsor Prof Joseph Ikechebelu nnewi onisha road, nnewi NNEWI 435001 Nigeria Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
DR. HENRIETTA OGBUNUGAFOR Awka Onitsha Road AWKA Nigeria
DR. FESTUS BASDEN .C. OKOYE Awka Onitsha Road AWKA Nigeria
DR. SHIRLEY NNEKA CHUKWURAH NNEWI ONITSHA ROAD NNEWI 435001 Nigeria
PROF. JOSEPH IFEANYICHUKWU IKECHEBELU nnewi onisha road, nnewi nnewi 435001 Nigeria
PROF. CHARLES .O. ESIMONE Awka Onitsha Road AWKA Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator George Eleje georgel21@yahoo.com +2348068117444 Nnewi Onitsha Road
City Postal code Country Position/Affiliation
Nnewi 435001 Nigeria Lecturer & Honorary Consultant, Nnamdi Azikiwe Univ Awka
Role Name Email Phone Street address
Public Enquiries Charles Esimone co.esimone@unizik.edu.ng +2348062835781 Enugu Onitsha Road
City Postal code Country Position/Affiliation
Awka Nigeria Prof Dept Pharmaceutical Microbiol, Biotechnol, Nnamdi Azikiwe Univ, Awka, Nigeria
Role Name Email Phone Street address
Scientific Enquiries Joseph Ikechebelu jikechebelu@yahoo.com +2348034044189 49 Ikemba Drive
City Postal code Country Position/Affiliation
Nnewi 4535001 Nigeria Nnamdi Azikiwe Univ Teaching Hospital, Nnewi
REPORTING
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