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Table 3 Outcome measures

From: The effectiveness of a modified Gui Zhi Fu Ling Wan formulation (Gynoclear™) for the treatment of endometriosis: a study protocol for a placebo-controlled, double-blind, randomised controlled trial

Primary outcome measure:

 To evaluate the efficacy of Gynoclear™ by change in endometriosis-related pain based on the Endometriosis pain daily diary v3 (EPDD) scores.

Secondary outcome measures:

 To assess the change in health-related quality of life via the Endometriosis Health Profile (EHP-30), SF-12 and EQ. 5D scores.

 To assess any changes in use of pharmaceutical analgesics via the EPDD

 To assess any changes in dyspareunia (painful sexual intercourse) via the EPDD.

 To assess any changes in fatigue via the EPDD and fatigue severity scale (FSS)

 To assess any changes in restrictions to activities of daily living via the EPDD.

 To monitor the frequency and severity of adverse events during intervention period.

 To determine the cost-effectiveness of using Gynoclear™.

 To explore participant satisfaction with the intervention.