Dysmenorrhea PrimaryPhase 4NCT06908044
Assessing the Therapeutic Potential of a Traditional Botanical Remedy for Menstrual Pain: Insights From a Prospective Observational Analysis
A Phase 4 study testing Bryophyllum in people with Dysmenorrhea Primary, run by University of Zurich at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Bryophyllum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jan 2025to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Private Centre for Obstetrics and Gynecology "Geburt und Familie"
Aarau, Canton of Aargau, 5000
Paracelsus Zentrum am Grossmünster
Zurich, Canton of Zurich, 8001
About this study
Official title: Effectiveness of Bryophyllum Pinnatum in the Treatment of Primary Dysmenorrhea: a Prospective Observational Study
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:
Read more
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
- Being tested
- Bryophyllum
- Keywords
- Bryophyllum Pinnatum, Primary Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BryophyllumDrug
Bryophyllum Pinnatum - tablets, for 6 Months
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group with Bryophyllum Pinnatum | Experimental | The study group receive Bryophyllum Pinnatum (tablets) for 6 Months Receives: Drug: Bryophyllum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Jan 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908044
- Sponsor's protocol ID
- KEK-2024-01549
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the primary and secondary outcomes of each patients undergone treatment with Bryophyllum Pinnatum
Publications
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.
PubMed 38130407
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bryophyllum Pinnatum in the Treatment of Primary Dysmenorrhea: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06908044
- Acronym / sponsor ID
- KEK-2024-01549
- Conditions
- Dysmenorrhea Primary
- Keywords
- Bryophyllum Pinnatum, Primary Dysmenorrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group with Bryophyllum Pinnatum | Experimental | Drug: BryophyllumThe study group receive Bryophyllum Pinnatum (tablets) for 6 Months |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BryophyllumBryophyllum Pinnatum - tablets, for 6 Months | Drug | Treatment Group with Bryophyllum Pinnatum |
Primary outcome
Pain Score (Numeric Rating Intensity - NRI)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Results publication: PubMed 38130407Zurfluh 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.
- Individual participant dataSharing planned: Yes. We plan to share the primary and secondary outcomes of each patients undergone treatment with Bryophyllum Pinnatum
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bryophyllum in people with Dysmenorrhea Primary, run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (Numeric Rating Intensity - NRI) (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06908044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.