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Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth

NCT05110599 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-12-13

No results posted yet for this study

Summary

The present IIT (Investigator-Initiated Trial) study is a prospective, randomised, placebo-controlled, double blind trial.

Women hospitalised with signs of preterm birth can be recruited for the study. Participants will take study medication for 2 weeks (or until birth) and fill out a questionnaire at 3 time points (at baseline, after 1 week and after 2 weeks) to assess state of anxiety and sleep quality. Furthermore, information regarding adverse events and the further course of the pregnancy are recorded.

Conditions

Interventions

DRUG

Bryophyllum 50% chewable tablets

Each 350 mg tablet corresponds to 170 mg of leave press juice from Bryophyllum pinnatum, dried down to 17 mg by mixing with lactose; 100 mg dried BP matter in 1 g

OTHER

Placebo

Lactose with adaption in appearance and tast

Sponsors & Collaborators

  • Christian Haslinger

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-12
Primary Completion
2023-08-25
Completion
2023-10-01

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05110599 on ClinicalTrials.gov