Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth

NCT05110599 | Terminated Phase 2 DMC

• 1 other identifier: BASEC-Nr. 2021-00941
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Labor; Anxiety

Keywords

Bryophyllum pinnatum; Anxiety; Preterm labor; Sleep quality; Phytotherapy

Outcome Measures

Primary Outcomes (2)

• 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

  Assessment before treatment, after 1 week and after 2 weeks

• 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

  assessment before treatment, after 1 week and after 2 weeks

Secondary Outcomes (4)

• change in sleep quality

  assessment before treatment, after 1 week and after 2 weeks

• hospitalisation days

  from randomisation till birth or end of preterm period, whichever came first, up to 9 weeks.

• reached gestational age

  at birth

• incidence of Adverse Events

  up to 9 weeks

Study Arms (2)

Bryophyllum 50%

ACTIVE COMPARATOR

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.

Drug: Bryophyllum 50% chewable tablets

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Bryophyllum 50% chewable tablets DRUG

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

Bryophyllum 50%

Placebo OTHER

Lactose with adaption in appearance and tast

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Christian Haslinger: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (8)

• 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.

  PMID: 27220081 BACKGROUND

• 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.

  PMID: 16051414 BACKGROUND

• 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.

  PMID: 23343584 BACKGROUND

• 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.

  PMID: 24373544 BACKGROUND

• 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.

  PMID: 29945146 BACKGROUND

• 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.

  PMID: 30562827 BACKGROUND

• 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.

  PMID: 31685022 BACKGROUND

• 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.

  PMID: 33679416 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, Premature; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 48 h after hospitalisation patients can be randomized to the Bryophyllum group or the placebo group.

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 8, 2021
• Study Start: July 12, 2022
• Primary Completion: August 25, 2023
• Study Completion: October 1, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

CH (1)