NCT06908044

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

Effectiveness of Bryophyllum Pinnatum in the Treatment of Primary Dysmenorrhea: a Prospective Observational Study

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Bryophyllum	Bryophyllum Pinnatum - tablets, for 6 Months

Timeline

• Start date: 2025-01-01
• Primary completion: 2028-06-30
• Completion: 2028-12-31
• First posted: 2025-04-03
• Last updated: 2025-04-10

Locations

2 sites across 1 country: Switzerland