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Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth

Primary Purpose

Preterm Labor, Anxiety

Status
Recruiting
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Bryophyllum 50% chewable tablets
Placebo
Sponsored by
Christian Haslinger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Labor focused on measuring Bryophyllum pinnatum, Anxiety, Preterm labor, Sleep quality, Phytotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Single pregnancy
  • At least 18 years old
  • Stable clinical situation after complete tocolysis cycle of 48 h
  • Gestational age at randomisation >28 weeks (28+0) and <34 weeks (33+6)
  • Good German or English skills
  • Written informed consent

Exclusion Criteria:

  • Early premature rupture of the membranes (PPROM)
  • Factors that make soon delivery likely (pre-eclampsia, suspect cardiotocography, clinical signs of an amniotic infection)
  • Body temperature >38°C
  • Cervical length < 10 mm at beginning of tocolysis
  • Contraindication for B. pinnatum, lactose or wheat protein allergy
  • Taking Bryophyllum 50% chewable tablets or powder 48 h before study inclusion
  • Taking psychotropic drugs (Benzodiazepines, antidepressants, neuroleptics)
  • Diagnosed psychiatric disease (depression, anxiety disorder, adaptation disorder, post- traumatic stress disorder, bipolar disorder)
  • Active participation in another interventional study during the last 4 weeks
  • Known or suspected non-compliance with study protocol
  • Drug or alcohol abuse

Sites / Locations

  • University Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bryophyllum 50%

Placebo

Arm Description

Participants of the verum group take Bryophyllum 50% chewable tablets starting the day after study inclusion. Participants take 2 tablets, four times a day for 2 weeks. If the birth takes place before the end of the 2 weeks, the study participation is terminated early.

Participants of the control group take Placebo chewable tablets starting the day after study inclusion. Participants take 2 tablets, four times a day for 2 weeks. If the birth takes place before the end of the 2 weeks, the study participation is terminated early.

Outcomes

Primary Outcome Measures

change in situational state of anxiety
assessed with State-Trait-Anxiety-Inventory (STAI) values from 20 to 80, higher scores indicating worse state of anxiety
change in situational state of anxiety
assessed with Pregnancy-related Anxiety Questionnaire Revised 2 (PRAQ-R2) values from 10 to 50, higher scores indicating worse state of anxiety

Secondary Outcome Measures

change in sleep quality
assessed with Pittsburgh Sleep Quality Index (PSQI) values from 0 to 21, higher scores indicating worse sleep quality
hospitalisation days
reached gestational age
incidence of Adverse Events
occurence of Adverse Events

Full Information

First Posted
October 5, 2021
Last Updated
January 24, 2023
Sponsor
Christian Haslinger
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1. Study Identification

Unique Protocol Identification Number
NCT05110599
Brief Title
Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth
Official Title
Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth: a Randomised, Double-blind, Placebo-controlled Study as Investigator-Initiated Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christian Haslinger

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Preterm birth is one of the leading causes for mortality and morbidity in newborns and preterm contractions are the cause of a considerable part of preterm deliveries. In the treatment of preterm labour, tocolytic medications are often used that are associated with numerous side effects for the pregnant woman, which limits their use in time. Preparations from Bryophyllum pinnatum, which demonstrated excellent tolerability, constitute a safe alternative for tocolytic treatment. It was introduced as an alternative tocolytic by anthroposophic medicine in Europe and is used as a monotherapy or add-on therapy for preterm labour in many perinatal clinics in Switzerland today. In vitro studies support the use of B. pinnatum as a tocolytic. In addition, there are also limited options for the treatment of mental disorders and sleep disturbances during pregnancy. Anxiety plays a major role in the development of preterm labour and often leads to administration of tocolytics longer than necessary. Preparations from B. pinnatum have traditionally been in the treatment of anxiety. Improvements of sleep quality in pregnant women during treatment with B. pinnatum preparations were already shown in previous studies. This exploratory study aims at investigating the effects of B. pinnatum for the treatment of anxiety in patients with signs of preterm birth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor, Anxiety
Keywords
Bryophyllum pinnatum, Anxiety, Preterm labor, Sleep quality, Phytotherapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
48 h after hospitalisation patients can be randomized to the Bryophyllum group or the placebo group.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bryophyllum 50%
Arm Type
Active Comparator
Arm Description
Participants of the verum group take Bryophyllum 50% chewable tablets starting the day after study inclusion. Participants take 2 tablets, four times a day for 2 weeks. If the birth takes place before the end of the 2 weeks, the study participation is terminated early.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants of the control group take Placebo chewable tablets starting the day after study inclusion. Participants take 2 tablets, four times a day for 2 weeks. If the birth takes place before the end of the 2 weeks, the study participation is terminated early.
Intervention Type
Drug
Intervention Name(s)
Bryophyllum 50% chewable tablets
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Lactose with adaption in appearance and tast
Primary Outcome Measure Information:
Title
change in situational state of anxiety
Description
assessed with State-Trait-Anxiety-Inventory (STAI) values from 20 to 80, higher scores indicating worse state of anxiety
Time Frame
Assessment before treatment, after 1 week and after 2 weeks
Title
change in situational state of anxiety
Description
assessed with Pregnancy-related Anxiety Questionnaire Revised 2 (PRAQ-R2) values from 10 to 50, higher scores indicating worse state of anxiety
Time Frame
assessment before treatment, after 1 week and after 2 weeks
Secondary Outcome Measure Information:
Title
change in sleep quality
Description
assessed with Pittsburgh Sleep Quality Index (PSQI) values from 0 to 21, higher scores indicating worse sleep quality
Time Frame
assessment before treatment, after 1 week and after 2 weeks
Title
hospitalisation days
Time Frame
from randomisation till birth or end of preterm period, whichever came first, up to 9 weeks.
Title
reached gestational age
Time Frame
at birth
Title
incidence of Adverse Events
Description
occurence of Adverse Events
Time Frame
up to 9 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years old Hospitalisation with signs of preterm birth Gestational age at randomisation >22 weeks (22+0) and <35 weeks (34+6) Good German or English skills Written informed consent Exclusion Criteria: Early premature rupture of the membranes (PPROM) Factors that make soon delivery likely (pre-eclampsia, suspect cardiotocography, clinical signs of an amniotic infection) Body temperature >38°C Cervical opening or cervical length < 5 mm Contraindication for B. pinnatum, lactose or wheat protein allergy Taking Bryophyllum 50% chewable tablets or powder 48 h before study inclusion Taking psychotropic drugs (Benzodiazepines, antidepressants, neuroleptics) Diagnosed psychiatric disease (depression, anxiety disorder, adaptation disorder, post- traumatic stress disorder, bipolar disorder) Active participation in another interventional study during the last 4 weeks Known or suspected non-compliance with study protocol Drug or alcohol abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Haslinger, PD Dr. med.
Phone
+41 44 255 46 13
Email
christian.haslinger@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Paula Simões-Wüst, PD Dr. phil.
Phone
+41 44 255 51 31
Email
anapaula.simoes-wuest@usz.ch
Facility Information:
Facility Name
University Hospital Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Haslinger, MD
Email
christian.haslinger@usz.ch

12. IPD Sharing Statement

Citations:
PubMed Identifier
27220081
Citation
Furer K, Simoes-Wust AP, von Mandach U, Hamburger M, Potterat O. Bryophyllum pinnatum and Related Species Used in Anthroposophic Medicine: Constituents, Pharmacological Activities, and Clinical Efficacy. Planta Med. 2016 Jul;82(11-12):930-41. doi: 10.1055/s-0042-106727. Epub 2016 May 24.
Results Reference
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PubMed Identifier
16051414
Citation
Plangger N, Rist L, Zimmermann R, von Mandach U. Intravenous tocolysis with Bryophyllum pinnatum is better tolerated than beta-agonist application. Eur J Obstet Gynecol Reprod Biol. 2006 Feb 1;124(2):168-72. doi: 10.1016/j.ejogrb.2005.05.013. Epub 2005 Jul 26.
Results Reference
background
PubMed Identifier
23343584
Citation
Simoes-Wust AP, Jeschke E, Mennet M, Schnelle M, Matthes H, von Mandach U. Prescribing pattern of Bryophyllum preparations among a network of anthroposophic physicians. Forsch Komplementmed. 2012;19(6):293-301. doi: 10.1159/000345841. Epub 2012 Dec 17.
Results Reference
background
PubMed Identifier
24373544
Citation
Lambrigger-Steiner C, Simoes-Wust AP, Kuck A, Furer K, Hamburger M, von Mandach U. Sleep quality in pregnancy during treatment with Bryophyllum pinnatum: an observational study. Phytomedicine. 2014 Apr 15;21(5):753-7. doi: 10.1016/j.phymed.2013.11.003. Epub 2013 Dec 25.
Results Reference
background
PubMed Identifier
29945146
Citation
Simoes-Wust AP, Lapaire O, Hosli I, Wachter R, Furer K, Schnelle M, Mennet-von Eiff M, Seifert B, von Mandach U. Two Randomised Clinical Trials on the Use of Bryophyllum pinnatum in Preterm Labour: Results after Early Discontinuation. Complement Med Res. 2018;25(4):269-273. doi: 10.1159/000487431. Epub 2018 Jun 22. No abstract available.
Results Reference
background
PubMed Identifier
30562827
Citation
Santos S, Haslinger C, Klaic K, Faleschini MT, Mennet M, Potterat O, von Mandach U, Hamburger M, Simoes-Wust AP. A Bufadienolide-Enriched Fraction of Bryophyllum pinnatum Inhibits Human Myometrial Contractility In Vitro. Planta Med. 2019 Mar;85(5):385-393. doi: 10.1055/a-0810-7704. Epub 2018 Dec 18.
Results Reference
background
PubMed Identifier
31685022
Citation
Santos S, Haslinger C, Mennet M, von Mandach U, Hamburger M, Simoes-Wust AP. Bryophyllum pinnatum enhances the inhibitory effect of atosiban and nifedipine on human myometrial contractility: an in vitro study. BMC Complement Altern Med. 2019 Nov 4;19(1):292. doi: 10.1186/s12906-019-2711-5.
Results Reference
background
PubMed Identifier
33679416
Citation
Santos S, Zurfluh L, Mennet M, Potterat O, von Mandach U, Hamburger M, Simoes-Wust AP. Bryophyllum pinnatum Compounds Inhibit Oxytocin-Induced Signaling Pathways in Human Myometrial Cells. Front Pharmacol. 2021 Feb 18;12:632986. doi: 10.3389/fphar.2021.632986. eCollection 2021. Erratum In: Front Pharmacol. 2023 Feb 08;14:1141346.
Results Reference
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Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth

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