Zao Ren An Shen capsule for chronic insomnia Study protocol for a randomized, placebo-controlled trial
Yoann Birling, Alan Bensoussan, Jerome Sarris, Nicole Avard, Xiaoshu Zhu
MEDICINE | LIPPINCOTT WILLIAMS & WILKINS | Published : 2019
BACKGROUND: Zao Ren An Shen (ZRAS), a Chinese Herbal Medicine product, has been proposed as an alternative to recommended treatments for chronic insomnia. There is a lack of strong evidence supporting this proposition. AIMS: To assess the efficacy and safety of ZRAS capsule for chronic insomnia compared to placebo. METHODS: A parallel-group, double-blind, randomized-controlled trial will be performed in Western Sydney University, Australia. After a 1-week placebo run-in, adults with chronic insomnia (n = 90) will be randomized in a 1:1 ratio to receive either ZRAS capsule or placebo for 4 weeks. Insomnia severity (Insomnia Severity Scale score), sleep parameters (measured with the Consensus ..View full abstract
Awarded by NHMRC Clinical Research Fellowship
The authors would like to thank Yang Lan for her work about the trial equipment and the investigator's brochure, Suzannah Bourchier for her support on technical and regulatory matters, Paul Fahey for his help about statistical matters, Danielle Parker, Margaret He, Christine Murray, Dianna Porter, Mingxian Jia, Kylie Barr, and Sara Low for their comments and help on the study protocol, Natalie Connor, Jennifer Rodda, Beatrice Venkataya and Mike Armour for their help regarding the recruitment strategy. YB is a recipient of a Blackmores-NICM scholarship. JS is supported by an NHMRC Clinical Research Fellowship (APP1125000).