A protocol is a document which states the background, rationale and objectives of a trial and describes its design, methodology and organization, including statistical considerations, and the conditions under which it is to be performed and managed. The protocol should be developed by the joint effort of representatives from several disciplines including research subjects (if possible), health workers, acupuncturists and biostatisticians. The protocol should include the following:

1. the title of the clinical study;

2. a clear statement of the objectives and purpose of the study;

3. the justification of the proposed study based on the available information including a consideration of the data on the subject from modem as well as traditional literature;

4. site and the facilities where studies will be undertaken;

5. name, address and qualifications of each investigator;

6. the type of study (e.g. controlled, open) and trial design (parallel groups, randomization (methods and procedures);

7. entry and exclusion criteria for study subjects (which may be based on diagnostic criteria of either modem or traditional medicine);

8. number of study subjects needed to achieve the study objective, based on statistical considerations;

9. the subjective and objective clinical observations and laboratory tests which will be recorded during the course of the study;

10. acupuncture point(s) selected for the study, justification of selection of point(s) (departures from traditional and/or modem diagnostic acupuncture techniques) and description of the way to locate the point(s) in the clinic;

11. needle(s) and size(s) used in the study;

12. needling technique including direction, angle and depth for inserting needle(s), retaining time, positioning of the patient and stimulation such as rolling, raising and thrusting, frequency and range, and other supplementary stimulation (reducing or reinforcing) and De Qi. If electric stimulation is used, describe the model of machines, manufacturer, type of wave form, pulse duration, voltage, or current of stimulus, frequency and polarity of electric stimulation used for the study;

13. recording of adverse reactions;

14. control groups to be used;

15. schedule of treatment, treatment period and time;

16. criteria for other treatment that may or may not be given to subjects during the study;

17. methods of recording responses, methods of measurement, times of measurements and follow-up procedures;

18. methodology of the evaluation of results (e.g. statistical methods and reports on patients/participants who withdraw from the study);

19. information to be given to study subjects;

20. information to be given to the staff involved in the study;

21. time schedule for completion of the study;

22. medical care to be made available to patients during or after the study that if necessary may override protocol treatment;

23. ethical considerations and measures relating to the study;

24. relevant communications with appropriate regulatory authorities; and

25. list of literature referred to in the protocol.