4 research outputs found
Reference Intervals in Healthy Adult Ugandan Blood Donors and Their Impact on Conducting International Vaccine Trials
BACKGROUND: Clinical trials are increasingly being conducted internationally. In order to ensure enrollment of healthy participants and proper safety evaluation of vaccine candidates, established reference intervals for clinical tests are required in the target population. METHODOLOGY/PRINCIPAL FINDINGS: We report a reference range study conducted in Ugandan adult blood bank donors establishing reference intervals for hematology and clinical chemistry parameters. Several differences were observed when compared to previously established values from the United States, most notably in neutrophils and eosinophils. CONCLUSIONS/SIGNIFICANCE: In a recently conducted vaccine trial in Uganda, 31 percent (n = 69) of volunteers screened (n = 223) were excluded due to hematologic abnormalities. If local reference ranges had been employed, 83% of those screened out due to these abnormalities could have been included in the study, drastically reducing workload and cost associated with the screening process. In addition, toxicity tables used in vaccine and drug trial safety evaluations may need adjustment as some clinical reference ranges determined in this study overlap with grade 1 and grade 2 adverse events
Preclinical efficacy and safety of herbal formulation for management of wounds
Background: Medicinal plants in Uganda and other developing countries
have been scientifically demonstrated to have medicinal benefits but
few or none have been translated to products for clinical use. Most
herbal products developed by local herbalists and sold to the public
are not standardized and lack efficacy and safety data to support use.
Objective: To formulate from two Ugandan medicinal plants a herbal
product for wound management and test its preclinical safety and
efficacy using rat models. Methods: Thirty (30) Wistar albino rats were
randomly divided into three groups and wounds were surgically created
on the mid-dorsal region. The wounds were treated topically with
distilled water (group I), Jena® (group II)and Neomycin sulfate
cream (group III). The effects of the treatments on rate of wound
closure, epithelialisation time and histological organization of tissue
were assessed. Results: The herbal formulation (Jena) had a
significantly higher rate of wound closure than neomycin (p<0.05)
which itself was better than distilled water. Epithelialisation time
was also significantly shorter for the herbal product (p<0.01).
Histological picture revealed more collagen fibers, less inflammation
and better tissue remodeling for rats treated with herbal product.
Conclusion: The herbal formulation Jena® systematically designed
and formulated based on two Ugandan medicinal plants is according to
this study better than neomycin and probably other imported products
for wound management in Uganda. We recommend its trial in a clinical
setting as an alternative in wound management