Clinical trial NCT06908044: Assessing the Therapeutic Potential of a Traditional Botanical Remedy for Menstrual Pain: Insights From a Prospective Observational Analysis
Official title: Effectiveness of Bryophyllum Pinnatum in the Treatment of Primary Dysmenorrhea: a Prospective Observational Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Dysmenorrhea Primary
Keywords: Bryophyllum Pinnatum
Primary Dysmenorrhea
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Pain Score (Numeric Rating Intensity - NRI)
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Private Centre for Obstetrics and Gynecology "Geburt und Familie"
state: Aargau
city: Zurich
country: Switzerland
facility: Paracelsus Zentrum am Grossmünster
Study officials:
References:
citation: 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.