A Complex Multiherbal Regimen Based on Ayurveda Medicine for the Management of Hepatic Cirrhosis Complicated by Ascites: Nonrandomized, Uncontrolled, Single Group, Open-Label Observational Clinical Study
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