Clinical trial • Phase IV • Other

LUPULI FLOS DRY ALCOHOLIC EXTRACT, VALERIAN ROOT TE WITH ETHANOL/ETHANOL WATER, TROCKENEXTRAKT AUS PASSIONSBLUMENKRAUT 5-7:1, AUSZUGSMITTEL ETHANOL 60 % (V/V) for Cataract | Pars plana vitrectomy

Phase IV trial of LUPULI FLOS DRY ALCOHOLIC EXTRACT, VALERIAN ROOT TE WITH ETHANOL/ETHANOL WATER, TROCKENEXTRAKT AUS PASSIONSBLUMENKRAUT 5-7:1, AUSZUGSMIT…

Overview

Trial Therapeutic Area
Other
Trial Disease
Cataract | Pars plana vitrectomy
Trial Stage
Phase IV
Drug Modality
Other | Small molecule

Key dates

Initial CTIS Submission Date
05-08-2025
First CTIS Authorization Date
10-11-2025

Trial design

Bromazepam Genericon 3 mg Filmtabletten; authorized product (marketing authorisation AT, number 1-19858); route ORAL; max total daily dose reported 1.5 mg (doseUom mg).-controlled Phase IV trial across 1 site in Austria.

Comparator
Bromazepam Genericon 3 mg Filmtabletten; authorized product (marketing authorisation AT, number 1-19858); route ORAL; max total daily dose reported 1.5 mg (doseUom mg).
Target Sample Size
240
Trial Duration For Participant
1

Eligibility

Recruits 240 No vulnerable populations selected; participants must be capable of providing informed consent..

Pregnancy Exclusion
Pregnancy or breast-feeding.
Vulnerable Population
No vulnerable populations selected; participants must be capable of providing informed consent.

Inclusion criteria

  • {"criterion_text":"- Subjects above 18 years."}
  • {"criterion_text":"- Capable of providing informed consent."}
  • {"criterion_text":"- Requiring pars plana vitrectomy or cataract surgery on one eye only"}

Exclusion criteria

  • {"criterion_text":"- Any abnormalities preventing reliable measurement as judged by the investigator."}
  • {"criterion_text":"- Psychotropic drug intake as long-term daily therapy."}
  • {"criterion_text":"- High grade hearing impairment."}
  • {"criterion_text":"- Pregnancy or breast-feeding."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- NRS-P score 30 seconds after retrobulbar block.","definition_or_measurement_approach":"NRS-P score measured 30 seconds after retrobulbar block."}

Secondary endpoints

  • {"endpoint_text":"- STAI Questionnaire at admission","definition_or_measurement_approach":"STAI Questionnaire administered at admission."}
  • {"endpoint_text":"- NRS-P before retrobulbar injection","definition_or_measurement_approach":"NRS-P measured before retrobulbar injection."}
  • {"endpoint_text":"- NRS-A before retrobulbar injection","definition_or_measurement_approach":"NRS-A measured before retrobulbar injection."}
  • {"endpoint_text":"- NRS-P score 30 seconds after retrobulbar block","definition_or_measurement_approach":"NRS-P score measured 30 seconds after retrobulbar block."}
  • {"endpoint_text":"- NRS-P score directly after operation","definition_or_measurement_approach":"NRS-P measured directly after the operation."}
  • {"endpoint_text":"- NRS-A score directly after operation","definition_or_measurement_approach":"NRS-A measured directly after the operation."}
  • {"endpoint_text":"- Speed rate/duration of retrobulbar injection","definition_or_measurement_approach":"Measured speed rate/duration of the retrobulbar injection."}

Recruitment

Planned Sample Size
240
Recruitment Window Months
24
Consent Approach
Participants must be capable of providing informed consent. Subject information and informed consent form documents are listed (e.g. "L1_SIS and ICF_Master_redacted", "L2_Other subject information material questionaire STAI"). No assent process mentioned. A German (Austria) translation of the full title is present.

Geography

Total Number Of Sites
1
Total Number Of Participants
240

Austria

Earliest CTIS Part Ii Submission Date
13-10-2025
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
53
Number Of Sites
1
Number Of Participants
240

Sites

Site Name
Medical University Of Graz
Department Name
Department of Ophthalmology
Principal Investigator Name
Gerald Seidel
Principal Investigator Email
gerald.seidel@medunigraz.at
Contact Person Name
Gerald Seidel
Contact Person Email
gerald.seidel@medunigraz.at

Sponsor

Primary sponsor

Full Name
Medical University Of Graz
Organisation Type
Educational Institution
Country Of Registered Address
Austria

Investigational products

Investigational Product Name
Nervenruh forte - Dragees
Active Substance
LUPULI FLOS DRY ALCOHOLIC EXTRACT, VALERIAN ROOT TE WITH ETHANOL/ETHANOL WATER, TROCKENEXTRAKT AUS PASSIONSBLUMENKRAUT 5-7:1, AUSZUGSMITTEL ETHANOL 60 % (V/V)
Modality
Other
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation AT, number 736028)
Maximum Dose
1 (unit: Other, maxTotalDoseAmount)
Investigational Product Name
Bromazepam Genericon 3 mg Filmtabletten
Active Substance
BROMAZEPAM
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation AT, number 1-19858)
Maximum Dose
1.5 mg

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