Assessing the Therapeutic Potential of a Traditional Botanical Remedy for Menstrual Pain: Insights From a Prospective Observational Analysis

NCT ID: NCT06908044

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2028-12-31

Brief Summary

Primary dysmenorrhea (PDM) affects round 60 to 90% of women and has a great impact on everyday life of affected women, leading to decreased work productivity, cognitive activity and cuts in social life. The aetiology of pain symptoms mainly results from increased contractile activity. Non-rhythmic and uncoordinated contractions lead to high uterine pressure, which together with vasoconstriction result in reduced blood flow and ultimately in painful uterine ischemia. Conventional treatment options are limited to pain medication such as paracetamol, non-steroidal anti-inflammatory drugs (NSAID) or - especially, but not only, if contraception is also desired - hormonal contraceptives. Due to the frequent occurrence of (sometimes severe) side effects, there has been a lack of effective treatment options that can be taken regularly without hesitation. The succulent herb Bryophyllum pinnatum (BP) (Lam.) Oken. (Crassulaceae) (synonym: Kalanchoe pinnata) originated in Madagascar,but is at present found in wide-ranging (sub)tropical regions of Africa and Asia. In Switzerland, BP is often used in obstetrics and gynaecology, so far mainly for preterm labour (as a tocolytic), and in some cases for overactive bladder syndrome, nocturia and sleeping disorders, but not for dysmenorrhea. Current pharmacological data on the inhibition of myometrial contractile mechanisms by BP preparations as well as its reported use against inflammation and pain in ethnomedicine made us hypothesize that BP might be a new treatment option for PDM.

Primary objective of the study:

Assessment of the PDM - associated menstrual pain

Secondary objectives of the study:

Assessment of the quality of life in PDM Recording of AEs under study medication Compliance

Conditions

Dysmenorrhea Primary

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group with Bryophyllum Pinnatum

The study group receive Bryophyllum Pinnatum (tablets) for 6 Months

Group Type: EXPERIMENTAL

Bryophyllum

Intervention Type: DRUG

Bryophyllum Pinnatum - tablets, for 6 Months

Interventions

Bryophyllum

Bryophyllum Pinnatum - tablets, for 6 Months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 45 years with regular menstrual cycles (21-35 days)
• Menstrual pain rated 6 or higher on an 11-point PI-NRS during the most painful day
• In good general health
• Provided written informed consent
• Willing to maintain the same personal hygienic product throughout the study (e.g., tampons, pads, menstrual cups; no changes in menstrual hygiene practices allowed during the study)

Exclusion Criteria

• Secondary dysmenorrhea (i.e. in endometriosis, adenomyosis, urogenital malformations)
• Currently taking, or had taken in the past two months, hormonal forms of birth control
• Dysmenorrhea reasonably suspected to be due to a IUD
• Prior or current liver or kidney disease, inflammatory bowel disease, reproductive cancer (uterine, ovarian, etc.)
• Personal history of known hypersensitivity to the used drug or its ingredients or to drugs with a similar chemical structure
• Other diseases that do not allow the subject to assess the nature and scope as well as possible consequences of the clinical study
• Pregnant or breastfeeding women
• Signs that the subject is unlikely to comply with the protocol (e.g., unwillingness to cooperate)
• Alcohol/drug abuse
• Non-German speaking patients (Patient information is only available in German)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Private Centre for Obstetrics and Gynecology "Geburt und Familie"

Aarau, Canton of Aargau, Switzerland

Paracelsus Zentrum am Grossmünster

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

References

Zurfluh L, Spinelli MG, Betschart C, Simoes-Wust AP. Repurposing of Bryophyllum pinnatum for dysmenorrhea treatment: a systematic scoping review and case series. Front Pharmacol. 2023 Dec 1;14:1292919. doi: 10.3389/fphar.2023.1292919. eCollection 2023.

Reference Type: BACKGROUND

PMID: 38130407 (View on PubMed)

Other Identifiers

KEK-2024-01549

Identifier Type: -

Identifier Source: org_study_id