In short
Clinical trials involving LUPULI FLOS DRY ALCOHOLIC EXTRACT are being reviewed here in the context of patient research. The available trial data focus on perioperative anxiety and pain in people having eye surgery, and the study also looks at a herbal medicine and music during the procedure.
Key points
- Only one trial is provided for LUPULI FLOS DRY ALCOHOLIC EXTRACT. It is an interventional, low-intervention study in patients undergoing vitrectomy and/or cataract surgery. The trial is authorised and plans to enroll 240 participants. It focuses on perioperative anxiety and pain, with the main outcome measured by the NRS-P score 30 seconds after the retrobulbar block. The trial also mentions music and a herbal medicine as part of the study question.
Trial overview
The source data include one authorised interventional study linked to LUPULI FLOS DRY ALCOHOLIC EXTRACT, although the brief summary mainly describes research on music and a herbal medicine during eye surgery. The trial is about perioperative anxiety and pain, which means worry and discomfort around the time of surgery.
The study is listed for patients undergoing vitrectomy and/or cataract surgery, so it is focused on people having eye operations. The enrollment target is 240 participants.
Who the trial is for
This trial is aimed at patients who are having vitrectomy and/or cataract surgery. These are eye procedures, and the study is connected with retrobulbar anaesthesia, which is a way to numb the eye area for surgery.
The source data do not give extra details about age limits, sex, or other inclusion and exclusion rules. Because of that, the clearest answer is that the trial is for surgical eye patients in this setting.
What the study is trying to find out
The brief summary says the study wants to investigate the effect of music on perioperative pain and the effect of herbal medicine on perioperative pain. This means the researchers are trying to see whether these approaches change how much pain people feel around the operation.
Even though the trial title does not mention LUPULI FLOS DRY ALCOHOLIC EXTRACT directly, the provided data place it within the same clinical trial record. The article therefore focuses on the trial questions and patient group described in the source data.
Study design and phase
The study type is interventional, which means researchers assign an intervention and then measure the result. The phase is listed as Low Intervention, not as a classic drug phase such as phase 1, phase 2, or phase 3.
This design suggests a lower-risk research setting compared with many medicine trials, but the source data do not provide more detail on the exact study procedures. The status is Authorised, which means the study has official approval in the source record.
Main outcome being measured
The primary outcome is the NRS-P score 30 seconds after the retrobulbar block. NRS-P is a pain score on a numerical scale, so it is used to measure how strong the pain is.
Measuring pain very soon after the block helps researchers see the immediate effect of the study approach during surgery preparation. The source data do not list any secondary outcomes.
Study interventions mentioned
The interventions listed in the source data are Nervenruh forte - Dragees and Bromazepam Genericon 3 mg Filmtabletten. These are named in the trial record, but the data provided do not explain their exact role in the study beyond being listed as interventions.
The brief summary also mentions a herbal medicine and music, which suggests that the trial is comparing or testing non-drug and medicine-based approaches for perioperative pain. The source data do not give dosing details, treatment schedules, or results.