I am planning a fixed-sequence 2-treatment (placebo followed by drug) crossover study. There is a Placebo run-in period of 15 days. Placebo is the control and has no effect on BP. The aim is to prove the efficacy of the medicine for treatment of blood pressure. I take one measurement while on placebo (A) (control) for one month. And then treatment is given for 1 year. Measurements are taken after 3 months and 9 months of treatment. After this, dose of medicine is tapered by 30% for one month, BP is recorded again at 10 months and the minimum dose required to maintain BP is given till 1 year and the final measurement is taken.
Note is made about the experience of the recording nurses-junior or senior (>5 years’ experience).
BP recordings are made in A/C and Non-A/C rooms for studying the effect of ambient temperature.
There is no funding for the study.
The trial is a double-blind study till the 3rd month’s data collection and open-label after that because of practical difficulties in blinding the medicine. This fixed sequence 3-period 2-treatment (AB) crossover design study is done on about 150 patients.
The hypothesis is that medicine normalizes BP, Non-A/C rooms increase BP and senior nurses’ recordings show lower readings.