The development of a protocol should be the joint effort of representatives from several disciplines such as clinical pharmacologists, pharmacists, biostatisticians, physicians and other relevant health care workers, as well as experts in traditional medicine. Ordinarily, the protocol group is chaired by the chief investigator, who is a physician. The protocol should include the following:
1. The title of the trial.
2. A clear statement on the objectives of the study.
3. The justification of the proposed trial based on the available information on safety and efficacy, including a consideration of the non-clinical data as well as the drug utilization pattern and the disease spectrum for the country concerned.
4. The rationale for the composition of the formula being studied and its relation to the principles of both herbal medicine and pharmacodynamic data.
5. The type of trial (such as controlled, open) and trial design (parallel groups, cross-over techniques), blind technique (double blind, single blind), randomization (methods and procedures).
6. Entry and exclusion criteria for study subjects (which may be based on diagnostic criteria of either modern or traditional medicine).
7. Number of trial subjects needed to achieve the trial objective, based on statistical considerations.
8. The therapeutic or clinical end points that are to be analysed at the conclusion of the trial (the unique nature of traditional medicine, which can relate to subjective wellness or quality of life, should also be considered when selecting the end points of the trial).
9. Control groups to be used (whether a therapeutic control group or a placebo group is used will depend on the disease being studied and the availability of alternative modern drugs or herbal medicines of proven efficacy).
10. The subjective and objective clinical observations and laboratory tests which will be recorded during the course of the trial.
11. The treatment schedule for the duration of the trial, including dosage form and route of administration and the details of the product being used as a therapeutic control.
12. Criteria for other treatments that may or may not be given to subjects during the trial.
13. Procedures for the maintenance of subject identification code lists, treatment record, randomization list and/or Case Report Form (CRF).
14. Information on establishment of the trial code, where it will be kept and when, how and by whom it can be broken in the event of an emergency.
15. The qualifications and experience of the investigators.
16. The facilities and the sites where studies will be undertaken.
17. Methodology for the evaluation of results (such as statistical methods and reports on patients or participants who withdrew from the trial).
18. Information to be given to trial subjects.
19. Relevant communications with appropriate regulatory authorities.
20. Information given to the staff involved in the trial.
21. Medical care to be made available to patients after the trial.
22. List of literature referred to in the protocol.
When considering the above items, special attention must be given to designing a protocol that eliminates bias and reduces variance.