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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group with Bryophyllum Pinnatum | Experimental | The study group receive Bryophyllum Pinnatum (tablets) for 6 Months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bryophyllum | Drug | Bryophyllum Pinnatum - tablets, for 6 Months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score (Numeric Rating Intensity - NRI) | 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 | From enrollment to the end of treatment at 6 months |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Centre for Obstetrics and Gynecology "Geburt und Familie" | Aarau | Canton of Aargau | 5000 | Switzerland | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38130407 | Result | 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. |
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We plan to share the primary and secondary outcomes of each patients undergone treatment with Bryophyllum Pinnatum
from the end of the study (31/12/2028) for 10 years
Researchers who want to reaserch further Bryophyllum Pinnatum in Dysmenorrhea or related research topics. They can contact the PI to receive information. They will receive the row data of the outcomes of each patient.
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| Paracelsus Zentrum am Grossmünster |
| Zurich |
| Canton of Zurich |
| 8001 |
| Switzerland |