PHASE 1 Patients (8-week treatment from Jul-Sept 2022) and Week 16-20 review (Oct-Nov 2022) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Review | N | PRIMARY OUTCOME | SECONDARY OUTCOME | TERTIARY OUTCOME | ||||||
Week 8 | CCR | PCR | NCR | CCR | PCR | NCR | CCR | PCR | NCR | |
DGBI | 16 | 11 | 5 | 0 | 11 | 5 | 0 | 11 | 5 | 0 |
IBD | 3 | 1 | 2 | 0 | 1 | 2 | 0 | 1 | 2 | 0 |
Week 16- 20 | CCR | PCR | NCR | CCR | PCR | NCR | CCR | PCR | NCR | |
DGBI | 16 | 14 | 2 | 0 | 14 | 2 | 0 | 14 | 2 | 0 |
IBD | 3 | 2 | 1 | 0 | 1 | 2 | 0 | 2 | 1 | 0 |
PHASE 2 Patients (8 -week treatment from Sept - Nov 2022) | ||||||||||
Review | N | PRIMARY OUTCOME | SECONDARY OUTCOME | TERTIARY OUTCOME | ||||||
Week 8 | CCR | PCR | NCR | CCR | PCR | NCR | CCR | PCR | NCR | |
DGBI | 16 | 11 | 5 | 0 | 11 | 5 | 0 | 11 | 5 | 0 |
IBD | 3 | 2 | 1 | 0 | 2 | 1 | 0 | 2 | 1 | 0 |
CCR (Complete Clinical Response) – Complete relief of symptom(s)
PCR (Partial Clinical Response) – Discernible improvement in symptom(s)
NCR (No Clinical Response) – No change in symptom(s) N= Number of patients