Ethics Committee Review

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The Committee, in principle, is in agreement with the project, however, the following observations are made regarding aspects that need to be attended to or modified: 1.The Principal Investigator’s prior experience with herbal medicines/alternative medicines studies is not mentioned in the protocol. 2. Research Design: • The study is described as a double blind placebo controlled design. However, it is not mentioned whether it is a parallel or a cross-over design. The details show it is a parallel assignment study. It is suggested that a study flow chart should be provided to enable a quick assessment. • The visit schedule for the subjects is not clearly described. In the synopsis, the schedule is different than the one described in the main body of the protocol. • Schedule of Visits in Table 3.1.1, on page 15, is not clear and needs revision. • Secondly, there should be a system to remind the subjects of the next visit e.g. by telephone or email. This would facilitate the subjects in remembering and complying with the visit schedule. • Randomization, allocation concealment and blinding procedure should be described in detail. • Under what circumstances would blinding be broken/revealed. 3. Intervention: • No reference is given for selecting the dose of 400mg twice a day. Please provide information on how the dose was calculated and decided upon. • The study is planned to test only one dose level. A strategy to look at progressively ascending doses would help assess a maximum tolerated dose for this herb. • The ‘Placebo’ is described to contain spinach leaves. Is spinach completely a placebo without any documented pharmacological effects? Please comment. • In ‘real life’ scenarios, herbal medicines are used in various f... ... middle of paper ... .... van Wyk, B.-E. and Gericke, N. 2000. People’s Plants. A Guide to the Useful Plants of Southern Africa. Briza, Pretoria. 4. Rood, B. 1994. Uit die Veldapteek. Tafelberg, Cape Town. (Translation of title: “Out of the field-pharmacy”). 5. Von Koenen, E. 1996. Heil- Gift und Essbare Pflanzen in Namibia. Edition Namibia. Klaus Hess Verlag. (Translation of title: Medicinal, Poisonous and edible plants of Nambia). 6. Watt, J.M. and Breyer-Brandwijk, M.G. 1962 (2nd edition). The Medicinal and Poisonous Plants of Southern and Eastern Africa. E&S Livingstone Ltd., Edinburgh. 7. Pappe, L. 1857. Florae Capensis Medicae Prodromus. 2nd Edition. Brittain, Cape Town. 8. Smith, C.A. 1966. Common Names of South African Plants. Botanical Survey Memoir No. 35. Government Printer, Pretoria. 9. Roberts, M. 1990. Indigenous Healing Plants. Southern Book Publishers, Halfway House.

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