Table 1.
Timeline of the study.
| Phase | Event | Measure | Week |
|---|---|---|---|
| Prephase | Screening | (i) Inclusion and exclusion criteria | Week 0 |
| Main observation period (IPD) | Baseline visit (V0) | (i) Clinical and laboratory investigations (ii) Admission to IPD |
Week 1 (day 1) |
| Phase 1 | (i) Piper longum Linn. administration (specific dose pattern) (ii) Strict diet and lifestyle measures |
Weeks 1 & 2 (days 1–13) |
|
| Phase 2 | (i) Purgation (ii) Strict diet and lifestyle measures |
Week 2 (day 14) |
|
| Phase 3 | (i) Drug administration (ii) Strict diet and lifestyle measures |
Weeks 3–6 | |
| First visit (V1) | (i) Clinical and laboratory investigations (ii) Discharge from IPD |
Week 7 | |
| Follow-up (OPD) Phase 4 |
(i) Continued drug administration (ii) Diet and lifestyle measures |
Weeks 7–24 | |
| Second visit (V2) | (i) Clinical and laboratory investigations | Week 24 |