Double-blind, placebo-controlled, randomised cross-over clinical trial of NIPRISAN® in patients with Sickle Cell Disorder

The study was undertaken to determine the safety and efficacy of NIPRISAN ®, a phytomedicine, developed for the management of patients with Sickle Cell Disorder (SCD). The study design is a placebo-controlled double blind cross-over trial. Eighty-two (82) patients with SCD were recruited and randomi...

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Bibliographic Details
Published in:	Phytomedicine (Stuttgart) Vol. 8; no. 4; pp. 252 - 261
Main Authors:	Wambebe, C., Khamofu, H., Momoh, J.A.F., Ekpeyong, M., Audu, B.S., Njoku, O.S., Bamgboye, E.A., Nasipuri, R.N., Kunle, O.O., Okogun, J.I., Enwerem, M.N., Audam, J.G., Gamaniel, K.S., Obodozie, O.O., Samuel, B., Fojule, G., Ogunyale, O.
Format:	Journal Article
Language:	English
Published:	Germany Elsevier GmbH 01-07-2001
Subjects:	acute toxicity Adolescent Adult Anemia, Sickle Cell - drug therapy Child Child, Preschool crisis Cross-Over Studies Double-Blind Method Female Humans Male Middle Aged NIPRISAN Pain - drug therapy Phytotherapy Plant Extracts - administration & dosage Plant Extracts - adverse effects Plant Extracts - therapeutic use severe pains Sickle Cell Disorder Treatment Outcome NIPRISAN severe pains crisis acute toxicity Sickle Cell Disorder
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Summary:	The study was undertaken to determine the safety and efficacy of NIPRISAN ®, a phytomedicine, developed for the management of patients with Sickle Cell Disorder (SCD). The study design is a placebo-controlled double blind cross-over trial. Eighty-two (82) patients with SCD were recruited and randomised into two groups. An initial 4 month pre-trial study was undertaken to determine the similarity of the groups. The main study was conducted over a twelve-month period with cross-over at six months. Safety of the drug was assessed clinically and biochemically. NIPRISAN ® significantly (P < 0.01) reduced the frequency of SCD crisis associated with severe pains. Acute toxicity to the liver assessed by the activities of liver enzymes, indicate that NIPRISAN ® is safe. Renal function assessed by the serum levels of creatinine and blood urea nitrogen remained normal. Both the clinical and laboratory results of the present phase IIB (pivot) clinical study suggest that NIPRISAN ® is a safe and efficacious phytomedicine for the management of patients with Sickle Cell Disorder.
ISSN:	0944-7113 1618-095X
DOI:	10.1078/0944-7113-00040