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.: PACTR201704001120121 Date of Approval: 28/04/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pilot Clinical Trial on HB01
Official scientific title A Randomized Pilot Clinical Study on the use of a Herbal Product, HB01, for the treatment of Adult HIV patients in Anambra State, Nigeria.
Brief summary describing the background and objectives of the trial Antiviral drug combinations utilized in HAART (Highly Active Anti-Retroviral Therapy) serves as the only conventionally available and accepted therapy for management of HIV (Human Immunodeficiency Virus) infection. However, these drugs have a vast array of side effects (which are pronounced when used in combination). Their availability is also limited such that only a portion of the Nigerian population can assess it easily. In addition, stigmatization, high levels of illiteracy and cultural beliefs has driven HIV positive individuals, either wholly or partially, to the use of herbal remedies. These reasons, as well as the increase in HIV targeted herbal medicines in which adequate safety and efficacy profiles have not been tested, have justified the need for this study. An ethical clearance will be obtained from the Anambra State University Teaching Hospital Amaku, Anambra State before the commencing the study. The study is aimed at monitoring adult HIV positive patients. The selected patients will be randomly allocated into two groups and will subsequently fill questionnaires that will enlighten us on their medical history. A sample of their blood will be obtained in order to establish baseline readings and patients will be sent home with the appropriate preparation that is entitled to each patients group. Blood samples will be withdrawn monthly for the next 3months. The blood samples will be used to determine the viral load, CD4+ cell count, liver function tests and serum electrolyte concentration for all patients during the course of the study. At the end of the study, the results of the viral load and CD4+ cell count will be primarily used to determine how effective HB01 was in managing the patients. The presence of adverse effects, liver function test enzymes and serum electrolyte concentration will be used to determine the safety of both HB01 and HB02. The results will be analyzed using the Statistical Package and Service Solutions (SPSS).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Other
Anticipated trial start date 04/05/2015
Actual trial start date 11/05/2015
Anticipated date of last follow up 18/08/2015
Actual Last follow-up date 18/08/2015
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants) 72
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 Randomization was done using computer generated codes from research randomizer at www.randomizer.com The preparations were labelled such that each individual had a corresponding preparation bearing his or her tag number. Only the sponsors would be aware of each participants' group. 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 HB01 A full glass of the liquid preparation taken twice daily Three months The intervention is a liquid herbal preparation said to be effective in Treatment of HIV infection 24 Placebo
Control Group HBp Half glass of the liquid preparation to be taken over a day Three months A liquid herbal preparation similar to the interventions in appearance and smell. It is non-toxic and has no known antiviral activity. 24 Placebo
Experimental Group HB01 A full glass of the liquid preparation taken twice daily Three months The intervention is a liquid herbal preparation said to be effective in Treatment of HIV infection 12 Placebo
Control Group HBp Half glass of the liquid preparation to be taken over a day Three months A liquid herbal preparation similar to the interventions in appearance and smell. It is non-toxic and has no known antiviral activity. 12 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Both male and female individuals. - Aged between 18-60years who are - Confirmed HIV positive patients. - Refusal of consent to the study. - Pregnancy (in women). - Falling outside the age bracket (18-60years). 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 02/04/2015 Anambra State University Teaching Hospital Ethical committee
Ethics Committee Address
Street address City Postal code Country
Anambra State Awka Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Viral load - Measured at the start of the study (baseline measurements) before administration of intervention. - Measured at the end of the study (three months after).
Primary Outcome CD4 count - Measured at the start of the study. - Measured at the end of the study.
Secondary Outcome Liver Function Test -Measured before the start to obtain baseline readings. -Measured after every 4 weeks till the trial elapses
Secondary Outcome Serum Electrolyte Concentration -Measured at the start of the study to get baseline readings. -Measured after every 4 weeks till the study ends.
Secondary Outcome Body mass index -Measured at the start to get baseline results. - Measurements taken at each weekly visit till the study ends.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Anambra State University Teaching Hospital, Amaku Anambra State Awka Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ogwaluonye Uchenna Nnamdi Azikiwe University Awka, Anambra State Nigeria
Prof C. O. Esimone Nnamdi Azikiwe University Awka Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof. J. I. Ikechebelu Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria Hospital
Primary Sponsor Prof. C. O. Esimone Nnamdi Azikiwe University Awka Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Dr. N. Ikechebelu Anambra State University Teaching Hospital Awka Nigeria
Mr. I. Ibeagha University of Nigeria Teaching Hospital Enugu Nigeria
Mr M. Ikegbunam Nnamdi Azikiwe University Awka Nigeria
Dr. Uchenna Eleje Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Uchenna Ogwaluonye pharmuchenna@yahoo.com +2347038139755 Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka Nigeria
Role Name Email Phone Street address
Public Enquiries Uchenna Ogwaluonye pharmuchenna@yahoo.com +2347038139755 Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka Nigeria
Role Name Email Phone Street address
Public Enquiries Uchenna Eleje georgel21@yahoo.com +2348068117444 Nnamdi Azikiwe University Teaching Hospital
City Postal code Country Position/Affiliation
Nnewi Nigeria
Role Name Email Phone Street address
Scientific Enquiries Uchenna Ogwaluonye pharmuchenna@yahoo.com +2347038139755 Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka Nigeria
Role Name Email Phone Street address
Scientific Enquiries Charles Esimone co.esimone@unizik.edu.ng +2348062835781 Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka Nigeria
Role Name Email Phone Street address
Scientific Enquiries Joseph Ikechebelu ji.ikechebelu@unizik.edu.ng +2348034044189 Nnamdi Azikiwe University Teaching Hospital
City Postal code Country Position/Affiliation
Nigeria
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