Bryophyllum vs. Nifedipine

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2006 by Weleda AG. Recruitment status was Not yet recruiting

First Received on October 19, 2006. No Changes Posted

Sponsor:	Weleda AG
Information provided by:	Weleda AG
ClinicalTrials.gov Identifier:	NCT00391339

Purpose

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.

Condition	Intervention	Phase
Tocolysis	Drug: Bryophyllum p.	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Bryophyllum p. Versus Nifedipine for the Treatment of Premature Contractions

Resource links provided by NLM:

Drug Information available for: Nifedipine

U.S. FDA Resources

Further study details as provided by Weleda AG:

Estimated Enrollment:	140
Study Start Date:	November 2006
Estimated Study Completion Date:	October 2008

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Female

Exclusion Criteria:

Bishop Score > 5

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391339

Locations

Switzerland
Department of Obstetrics, University of Zuerich	Not yet recruiting
Zuerich, Switzerland, 8091
Principal Investigator: Roland Zimmermann, Prof. Dr. med.
Principal Investigator: Ursula von Mandach, Prof. Dr. pharm.

Sponsors and Collaborators

Weleda AG

Investigators

Principal Investigator:

Roland Zimmermann, Prof. Dr. med.

Department of Obstetrics, University Zuerich

More Information

Additional Information:

Bryophyllum p. vs nifedipine in preterm labour This link exits the ClinicalTrials.gov site

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00391339 History of Changes
Other Study ID Numbers:	CI-C-64-Wel-06
Study First Received:	October 19, 2006
Last Updated:	October 19, 2006
Health Authority:	Switzerland: Swissmedic

Keywords provided by Weleda AG:

Bryophyllum p.
Nifedipine
Tocolysis

Additional relevant MeSH terms:

Nifedipine
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012