This clinical trial is focused on studying the effectiveness and safety of a new treatment for insomnia, a condition where individuals have trouble falling asleep or staying asleep. The treatment being tested is called Escholzia tablets, which is a newly developed medication. The study will compare the effects of these tablets to a placebo tablet that looks and feels the same but does not contain any active ingredients.
The purpose of the study is to evaluate how well the Escholzia tablets improve sleep quality and how safe they are for use. The study is divided into two phases. In the first phase, participants will be randomly assigned to receive either the Escholzia tablets or the placebo for one month. This phase is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. In the second phase, all participants will receive the Escholzia tablets for an additional two months to further assess the treatment’s safety and effectiveness.
Throughout the study, participants will be asked to keep a daily sleep diary and may wear a device to monitor their sleep patterns. The study will also look at changes in daytime sleepiness, mood, and overall quality of life. Additionally, some participants may provide saliva samples to measure levels of certain hormones related to stress and sleep. The study aims to provide valuable information on how Escholzia tablets can help people with insomnia improve their sleep and overall well-being.
Germany 
