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LUPULI FLOS DRY ALCOHOLIC EXTRACT

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.

Table of Contents

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.[1] The trial is about perioperative anxiety and pain, which means worry and discomfort around the time of surgery.[1]

The study is listed for patients undergoing vitrectomy and/or cataract surgery, so it is focused on people having eye operations.[1] The enrollment target is 240 participants.[1]

Who the trial is for

This trial is aimed at patients who are having vitrectomy and/or cataract surgery.[1] These are eye procedures, and the study is connected with retrobulbar anaesthesia, which is a way to numb the eye area for surgery.[1]

The source data do not give extra details about age limits, sex, or other inclusion and exclusion rules.[1] Because of that, the clearest answer is that the trial is for surgical eye patients in this setting.[1]

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.[1] This means the researchers are trying to see whether these approaches change how much pain people feel around the operation.[1]

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.[1] The article therefore focuses on the trial questions and patient group described in the source data.[1]

Study design and phase

The study type is interventional, which means researchers assign an intervention and then measure the result.[1] The phase is listed as Low Intervention, not as a classic drug phase such as phase 1, phase 2, or phase 3.[1]

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.[1] The status is Authorised, which means the study has official approval in the source record.[1]

Main outcome being measured

The primary outcome is the NRS-P score 30 seconds after the retrobulbar block.[1] NRS-P is a pain score on a numerical scale, so it is used to measure how strong the pain is.[1]

Measuring pain very soon after the block helps researchers see the immediate effect of the study approach during surgery preparation.[1] The source data do not list any secondary outcomes.[1]

Study interventions mentioned

The interventions listed in the source data are Nervenruh forte – Dragees and Bromazepam Genericon 3 mg Filmtabletten.[1] 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.[1]

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.[1] The source data do not give dosing details, treatment schedules, or results.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2024-520132-15-00Low InterventionPatients undergoing vitrectomy and/or cataract surgeryAuthorised240

FAQ

  • What is being studied in trials of LUPULI FLOS DRY ALCOHOLIC EXTRACT? The trial data provided focus on perioperative anxiety and pain during eye surgery. The study also looks at music and a herbal medicine in patients who receive retrobulbar anaesthesia.
  • Who may take part in this trial? The target population is patients undergoing vitrectomy and/or cataract surgery. These are people having eye operations, and the study is linked to retrobulbar anaesthesia.
  • What phase is the trial? The trial is listed as Low Intervention rather than a drug development phase. This means the study uses a lower-risk research design and does not describe a classic phase 1, 2, or 3 drug trial.
  • What outcome is the trial measuring? The main outcome is the NRS-P score 30 seconds after the retrobulbar block. NRS-P means a pain score on a simple rating scale.
  • What is the status of the trial? The trial status is Authorised. This means it has been approved to start or continue according to the source data.

Ongoing Clinical Trials on LUPULI FLOS DRY ALCOHOLIC EXTRACT

  • Study of herbal medicine combination and bromazepam for anxiety and pain in patients having eye surgery with retrobulbar anesthesia

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

Glossary

  • Perioperative: The time before, during, and after an operation.
  • Anxiety: A feeling of worry, fear, or nervousness.
  • Pain: An unpleasant feeling that can be mild or severe.
  • Retrobulbar anaesthesia: A type of local anaesthesia given around the eye to numb the area for surgery.
  • Retrobulbar block: The injection or step used to create numbness around the eye before surgery.
  • Vitrectomy: An eye operation that removes the vitreous, the gel-like material inside the eye.
  • Cataract surgery: An operation to remove a cloudy lens from the eye and replace it if needed.
  • Interventional study: A study where researchers actively give a treatment or intervention and measure the results.
  • Low Intervention: A study design that uses a lower level of risk or involvement than many drug trials.
  • NRS-P score: A pain rating score used to measure pain on a numerical scale.

References

  1. https://clinicaltrials.gov/study/2024-520132-15-00