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

Phase 4

Active, not recruiting

• Conditions: Dysmenorrhea Primary
• Interventions: Drug: Bryophyllum

• Registration Number: NCT06908044
• Lead Sponsor: University of Zurich

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Study First Posted: 2025-04-03
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2028-06-30
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group with Bryophyllum Pinnatum	Bryophyllum	The study group receive Bryophyllum Pinnatum (tablets) for 6 Months

Primary Outcome Measures

Name	Time	Method
Pain Score (Numeric Rating Intensity - NRI)	From enrollment to the end of treatment at 6 months	Measurement of the intensity of the pain during the menstrual periods: a score of 0 means no pain, a score of 10 means the maximal pain

Trial Locations

Locations (2)

Private Centre for Obstetrics and Gynecology "Geburt und Familie"; 🇨🇭 Aarau, Aargau, Switzerland

Paracelsus Zentrum am Grossmünster; 🇨🇭 Zurich, Switzerland