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

NCT06908044 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: KEK-2024-01549
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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

Keywords

Bryophyllum Pinnatum; Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment Group with Bryophyllum Pinnatum

EXPERIMENTAL

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

Drug: Bryophyllum

Interventions

Bryophyllum DRUG

Bryophyllum Pinnatum - tablets, for 6 Months

Treatment Group with Bryophyllum Pinnatum

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (2)

Private Centre for Obstetrics and Gynecology "Geburt und Familie"

Aarau, Canton of Aargau, 5000, Switzerland

Location

Paracelsus Zentrum am Grossmünster

Zurich, Canton of Zurich, 8001, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 38130407 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 3, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: from the end of the study (31/12/2028) for 10 years
• Access Criteria: 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.

Locations

CH (2)