This study got ethical approval from Faculty of Health and Social Care Sciences of Kingston University and St George's University of London thus leading to ATAS clearance in United Kingdom. Osun State University, Osogbo and Igbinedion University, Okada in Edo State also gave ethical approval to this study in Nigeria.
-Is a safe herbal concoction that contained saponins (titerpene glycosides), tannins, cardenolides, alkaloids and possibly anthraquinones (Onifade et al., 2010
). The adult table-spoon (about 10ml) of the concoction was diluted with about 50ml of warm water. The dosage was reduced to 5ml for paediatric patient. Each freshly constituted diluted medication was taken three times daily before food and normally for three months by patient at home (out-patient)
Patients were the HIV infected patients seeking herbal remedies as alternative or complementary therapy to HAART at α-Zam therapist herbal centres.
Herbal centre:Herbal therapist confidence was gained and consent sought for using his patients and herbal remedy for this study. All the new patients coming for treatment on out-patient were recruited into the study after counselling and gaining their consents. The herbal therapist recruits patient via well treated ‘former HIV patient’ and their relatives. The herbal therapist dispensed a monthly α-Zam dosage in 1litre container for patient to come back for monitoring and review (out-patient). Each patient's contact and address was taken for monitoring, bi-monthly visits and repeat of medical and laboratory examinations when necessary.
Patients' selection: Power calculation was used to determine the sample size for this study. The pilot study was done. The patients were selected based on HIV positive test result from the diagnosed orthodox hospitals (government and private) however, only 51 patients that were confirmed (Western blot) at LAUTECH teaching hospital and Ahmadu Bello University Teaching Hospital and completed their herbal therapy within 5 months between September 2008 and December 2009 were considered for this study.
Blood sample for HIV confirmatory test in Nigerian Government owned tertiary institution laboratory (LAUTECH Teaching Hospital, Osogbo and Ahmadu Bello Teaching Hospital, Zaria) were done on all the patients in this study. All the samples were sent for laboratory analysis in teaching hospitals on out-patient basis. The viral (HIV-RNA) load was done at research centre via the LAUTECH teaching hospital while the CD4 count and other laboratory tests were done at both teaching hospitals used for this study. The study conducted preliminary examinations (laboratory and medical) using World Health Organisation (WHO, 2007
) and Centre for Disease Control and Prevention (CDC, 1993
) staging criteria and identified associated opportunistic infections or systemic diseases. The patients taking HAART with α-Zam as complementary therapy were noted.
Medical examination: Skin, peripheral palpable lymph nodes, anaemia, body mass index, spleen, liver, kidney, chest, heart, including radiological investigations to ascertain the level of involvement of the organs
Laboratory- Immunology: CD4/CD8 count, B cell, Electrophoresis, ELISA and Western blotting techniques to confirm HIV infection.
Virology: viral (HIV-RNA) load using Polymerase Chain Reaction (PCR)
Haematology: Full Blood Count (FBC), blood film, Erythrocyte Sedimentation Rate (ESR)
Clinical chemistry: Electrolyte& Urea (E&U), Creatinine, Liver function test (LFT), C-reactive protein (CRP) and urinalysis.
Microbiology; blood microscopy, culture and sensitivity, sputum AAFB, urine microscopy and blood films for parasites when there was evidenced of infection