In a prospective, randomised study the efficacy and tolerability of bryophyllum p. (p.o) vs. nifedipine (p.o) will be proofed in a defined group of pregnant women with threatened preterm labour...
Date First Received: October 19, 2006
Last Updated: October 19, 2006
Verified by: Weleda AG, October 2006
Clinical Trial Phase: Phase 2/Phase 3 | Start Date: November 2006
Overall Status: Not yet recruiting
Estimated Enrollment: 140
Brief Summary
Official Title: “Bryophyllum p. Versus Nifedipine for the Treatment of Premature Contractions”
Condition Keyword(s):
Intervention(s):
In a prospective, randomised study the efficacy and tolerability of bryophyllum p. (p.o) vs.
nifedipine (p.o) will be proofed in a defined group of pregnant women with threatened preterm labour.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Bryophyllum p.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Female
Exclusion Criteria:
- Bishop Score > 5
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Weleda AG
Overall Clinical Trial Officials and Contacts
Roland Zimmermann, Prof. Dr. med. Principal Investigator Department of Obstetrics, University Zuerich
Related Publications
References
Plangger N, Rist L, Zimmermann R, Mandach UV. Intravenous tocolysis with Bryophyllum pinnatum is better tolerated than beta-agonist application. Eur J Obstet Gynecol Reprod Biol. 2005 Jul 25; [Epub ahead of print]
Gwehenberger B, Rist L, Huch R, von Mandach U. Effect of Bryophyllum pinnatum versus fenoterol on uterine contractility. Eur J Obstet Gynecol Reprod Biol. 2004 Apr 15;113(2):164-71.
Vilaghy I. [Decreasing the rate of premature delivery with phytotherapy--results from general practice] Ther Umsch. 2002 Dec;59(12):696-701. German.
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00391339
Study ID Number: CI-C-64-Wel-06
ClinicalTrials.gov Identifier: NCT00391339
Health Authority: Switzerland: Swissmedic
Clinical Trials Authorship and Review
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