The Committee, in principle, agrees with the project, however, the following observations are made regarding the aspects that need to be addressed or modified: 1. The previous experience of the principal investigator with herbal drug/alternative medicine studies are not mentioned in the protocol.2. Research Design: • The study is described as a double-blind, placebo-controlled design. However, it is not specified whether this is a parallel or crossed design. The details show that this is a parallel assignment study. It is suggested that a flowchart of the study be provided to enable rapid evaluation. • The visit schedule for the subjects is not clearly described. In the synopsis, the program is different from that described in the main part of the protocol. • The visit schedule in Table 3.1.1, on page 15, is unclear and needs revision. • Secondly, there should be a system to remind subjects of the next visit, for example by telephone or email. This would make it easier for subjects to remember and stick to the visit schedule. • Randomisation, allocation concealment and blinding procedure should be described in detail. • Under what circumstances would the concealment be broken/revealed.3. Intervention:• No reference is provided for the choice of dose of 400 mg twice daily. Please provide information on how the dose was calculated and decided. • The study is designed to test only one dose level. A strategy that takes into account progressively increasing doses would help evaluate the maximum tolerated dose for this herb. • “Placebo” is said to contain spinach leaves. Is spinach completely a placebo with no documented pharmacological effects? Please comment.• In 'real life' scenarios, herbal medicines are used in various f...... middle of article ....... van Wyk, B.-E. and Gericke, N. 2000. Popular plants. A guide to the useful plants of southern Africa. Briza, Pretoria.4. Rood, B. 1994. Uit die Veldapteek. Tafelberg, Cape Town. (Translation of the title: “Pharmacy off-screen”).5. Von Koenen, E. 1996. Heil- Gift und Essbare Pflanzen in Namibia. Namibian edition. 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. Brittany, Cape Town.8. Smith, C. A. 1966. Common names of South African plants. Memory of the botanical survey n. 35. Government Printer, Pretoria.9. Roberts, M. 1990. Indigenous Healing Plants. Southern Book Publishers, Halfway House.