NocturiaNCT04480658
Effectiveness of Bryophyllum in Nocturia-Therapy
A study testing Bryophyllum pinnatum 50 %, tablets into capsules (verum: 2x2capsules/day) in people with Nocturia and Sleep Disorder, run by University of Zurich at 1 site in Switzerland.
Trial summary
Night-time micturition, called nocturia, is a very common problem that unfavourably influences sleep- and life-qualities. The International Continence Society (ICS) defines nocturia as micturition once or several times during the night. Nocturia is one of the cardinal symptoms of overactive bladder (OAB). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nocturia, Sleep Disorder
- What is being tested?
- Bryophyllum pinnatum 50 %, tablets into capsules (verum: 2x2capsules/day)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2018to 14 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nocturia ≥2 Mal per a night
- Overactive bladder (>8 Mictions/day)
- Age > 18 Years
- local or systemic Therapy with Estrogen, if the therapy dates >4 Weeks before study-start.
- prior incontinence operation (if the operation dates back more than 6 months)
- german speaking Patients and a given informed consent
Who cannot join
- Intolerance against a substance or a compound
- participation in an other study 4 weeks prior to inclusion
- urinary tract infection
- drug abuse
- bladder affecting drugs like anticholinergics, diuretics, muscle relaxing medicaments and phytotherapeutics
- lactose intolerance
- Pregnant and lactating women
- Incompliance of Patient
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Hospital, Clinic for Gynecology
Zurich, 8091
About this study
Official title: Effectiveness of Bryophyllum Pinnatum by Patients With Nocturia and Its Effect on Sleep Quality
Night-time micturition, called nocturia, is a very common problem that unfavourably influences sleep- and life-qualities. The International Continence Society (ICS) defines nocturia as micturition once or several times during the night. Nocturia is one of the cardinal symptoms of overactive bladder (OAB). Persons with nocturia have the intention to continue sleep after going to the toilet which does not succeed to the same extent, depending on age.
The natural occurrence of the plant, Bryophyllum pinnatum (BP) which is used in this observational study origins from Madagascar as well as in tropical Africa, South America and Asia. In the folk medicine of these countries BP is widely used. BP has a calming, spasmolytic, anti-inflammatory, pain-relieving, diuretic and cytotoxic effects.
Read more
According to previous preclinical and clinical studies the inhibiting effect of BP on overactive bladder was proven. The pharmacological effect of this plant on uterine smooth muscle cells, on spontaneous and oxytocin-stimulated contractions, and on detrusor muscle cells in an in-vitro model of the pig's bladder was shown. Smooth muscle relaxation is not only required for preventing premature labour but also for symptom's relief of overactive bladder (OAB). The flavonoid, aglycons and bufadienolides, are components of the pressed juice of the BP leaves that have comparable effects to the standard drug oxybutynin on vesical smooth muscle cells.
Since many year BP is used in obstetrics not only as tocolytics but also as a sedative and sleeping pill.
There are known only few adverse events, such as skin irritation by intravenous application.
The interest in phytotherapeutical drugs for treatment the chronic diseases is very high and Bryophyllum is also frequently used in Switzerland for hyperactive conditions.
In Switzerland, following the vote on complementary medicine on 17.05.2009, alternative treatments will be covered by basic health insurance. Definitive inclusion in the catalogue of benefits will be granted if effectiveness, safety and cost-effectiveness can be demonstrated.
The potential and side-effect profile of BP, as well as the social interest in research into alternative methods is the background to the implementation of this observational study.
Read the detailed description
In the therapeutic concept of the treatment of OAB, antimuscarinic drugs play a central role. Antimuscarinics are known to inhibit the contraction of detrusor muscle (smooth muscle cells) and block the muscarinic receptor (M2/M3) important for efferent nerve conduction. This conventional therapy for OAB can have important adverse effects, notably on the gastrointestinal tract with constipation, on the excretory glands in the sense of xerostomia/xerophthalmia, on the nerve cells of the brain inhibiting cognitive function and in the heart muscle cells accelerating the heart rate. Especially elderly people are affected by these undesirable effects. Because of changes in the receptor profile, the effect of antimuscarinics and improvement of symptoms might be lowered in elderly people and another substance with less side effects would be of great interest. No such adverse effects are reported for B. pinnatum. Until now, there are few data for its use in OAB. Efficacy and tolerability of B. pinnatum in the treatment of OAB are the major outcome measures of this clinical trial.
- 50 women are included in this observational study, treated with Bryophyllum pinnatum in form of the commercially available Bryophyllum tablets into capsules (verum: 2x2capsules/day). Recruitment time is planned from January, 2018 to January 2022.
- Duration of the drug administration is 3 weeks.
- Primary endpoint are the reduction of nocturia (measured by filling in a voiding dairy) and the change of sleep-quality (measured by using Pittsburgh Sleep Quality Index)
- secondary endpoints are the improvement of quality of life (measured by using the King's Health Questionnaire and the International Consultation on Incontinence Overactive Bladder Questionnaire (ICIQ-OAB), two questionnaires, validated for the German language and for women with incontinence), increase of the micturition volumes and reduction of urge episodes (measured by the patients and recorded in a voiding dairy) and the registration of adverse events during the study phase. Ethics committee approval has been given.
- Conditions
- Nocturia, Sleep Disorder
- Being tested
- Bryophyllum pinnatum 50 %, tablets into capsules (verum: 2x2capsules/day)
- Medical subject headings
- Nocturia, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bryophyllum pinnatum 50 %, tablets into capsules (verum: 2x2capsules/day)Drug
Bryophyllum is administered for 3 weeks. Bryophyllum is given in form of capsules, 350mg per capsule, 0-0-2-2/d: 2 capsules 30min. before supper,2 capsules before going to bed.
Other Names:
Bryophyllum pinnatum/Kalanchoe
| Study group | Role | What they receive |
|---|---|---|
| Bryophyllum pinnatum | Experimental | Bryophyllum pinnatum (BP) muscle relaxing substance Receives: Drug: Bryophyllum pinnatum 50 %, tablets into capsules (verum: 2x2capsules/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of nocturia frequency
micturition protocol will be handed over during the baseline visit, it will be filled three days before the second visit in 1 week( therapy-start), follow-up control 3 weeks after medication intake and after the completed medication period ]
Measured: 4 Weeks
Sleep-Quality.
Pittsburgh Sleep Quality Index (PSQI; score 0-21) will be handed over during the baseline visit and will be filled three days before the second visit in 1 Week and three days after the therapy-end (after 3 Weeks). The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: 4 Weeks
Secondary outcomes (3)
Changes of overactive bladder symptoms
quality of life is measured by the ICIQ-OAB (score 0-16), a specific questionnaire for OAB
Measured: before the second visit in 1 week, at follow-up control 3 weeks after begin of medication intake and 4 weeks after end of medication intake.
Safety of Bryophyllum: adverse events
during medication intake at 1 week and 3 weeks after start of medication intake, measured by a personal adverse event protocol
Measured: 4 weeks
Daytime sleepiness
quality of life is measured by Epworth Sleepiness Scale Questionnaire (score 0-24)
Measured: before the second visit in 1 week, at follow-up control 3 weeks after begin of medication intake and 4 weeks after end of medication intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Jan 2018
- Primary completion18 Feb 2021
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480658
- Sponsor's protocol ID
- 2017-01964
- Other IDs
- 2017
- Status last verified
- Jan 2022
- First submitted
- 13 Jul 2020
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bryophyllum Pinnatum by Patients With Nocturia and Its Effect on Sleep Quality
- ClinicalTrials.gov ID
- NCT04480658
- Acronym / sponsor ID
- 2017-01964
- Conditions
- Nocturia, Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 21 Jul 2020 (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.
Night-time micturition, called nocturia, is a very common problem that unfavourably influences sleep- and life-qualities. The International Continence Society (ICS) defines nocturia as micturition once or several times during the night. Nocturia is one of the cardinal symptoms of overactive bladder (OAB). Persons with nocturia have the intention to continue sleep after going to the toilet which does not succeed to the same extent, depending on age.
The natural occurrence of the plant, Bryophyllum pinnatum (BP) which is used in this observational study origins from Madagascar as well as in tropical Africa, South America and Asia. In the folk medicine of these countries BP is widely used. BP has a calming, spasmolytic, anti-inflammatory, pain-relieving, diuretic and cytotoxic effects.
According to previous preclinical and clinical studies the inhibiting effect of BP on overactive bladder was proven. The pharmacological effect of this plant on uterine smooth muscle cells, on spontaneous and oxytocin-stimulated contractions, and on detrusor muscle cells in an in-vitro model of the pig's bladder was shown. Smooth muscle relaxation is not only required for preventing premature labour but also for symptom's relief of overactive bladder (OAB). The flavonoid, aglycons and bufadienolides, are components of the pressed juice of the BP leaves that have comparable effects to the standard drug oxybutynin on vesical smooth muscle cells.
Since many year BP is used in obstetrics not only as tocolytics but also as a sedative and sleeping pill.
There are known only few adverse events, such as skin irritation by intravenous application.
The interest in phytotherapeutical drugs for treatment the chronic diseases is very high and Bryophyllum is also frequently used in Switzerland for hyperactive conditions.
In Switzerland, following the vote on complementary medicine on 17.05.2009, alternative treatments will be covered by basic health insurance. Definitive inclusion in the catalogue of benefits will be granted if effectiveness, safety and cost-effectiveness can be demonstrated.
The potential and side-effect profile of BP, as well as the social interest in research into alternative methods is the background to the implementation of this observational study.
Detailed description
In the therapeutic concept of the treatment of OAB, antimuscarinic drugs play a central role. Antimuscarinics are known to inhibit the contraction of detrusor muscle (smooth muscle cells) and block the muscarinic receptor (M2/M3) important for efferent nerve conduction. This conventional therapy for OAB can have important adverse effects, notably on the gastrointestinal tract with constipation, on the excretory glands in the sense of xerostomia/xerophthalmia, on the nerve cells of the brain inhibiting cognitive function and in the heart muscle cells accelerating the heart rate. Especially elderly people are affected by these undesirable effects. Because of changes in the receptor profile, the effect of antimuscarinics and improvement of symptoms might be lowered in elderly people and another substance with less side effects would be of great interest. No such adverse effects are reported for B. pinnatum. Until now, there are few data for its use in OAB. Efficacy and tolerability of B. pinnatum in the treatment of OAB are the major outcome measures of this clinical trial.
- 50 women are included in this observational study, treated with Bryophyllum pinnatum in form of the commercially available Bryophyllum tablets into capsules (verum: 2x2capsules/day). Recruitment time is planned from January, 2018 to January 2022.
- Duration of the drug administration is 3 weeks.
- Primary endpoint are the reduction of nocturia (measured by filling in a voiding dairy) and the change of sleep-quality (measured by using Pittsburgh Sleep Quality Index)
- secondary endpoints are the improvement of quality of life (measured by using the King's Health Questionnaire and the International Consultation on Incontinence Overactive Bladder Questionnaire (ICIQ-OAB), two questionnaires, validated for the German language and for women with incontinence), increase of the micturition volumes and reduction of urge episodes (measured by the patients and recorded in a voiding dairy) and the registration of adverse events during the study phase. Ethics committee approval has been given.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bryophyllum pinnatum | Experimental | Drug: Bryophyllum pinnatum 50 %, tablets into capsules (verum: 2x2capsules/day)Bryophyllum pinnatum (BP) muscle relaxing substance |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Nocturia ≥2 Mal per a night
- Overactive bladder (>8 Mictions/day)
- Age > 18 Years
- local or systemic Therapy with Estrogen, if the therapy dates >4 Weeks before study-start.
- prior incontinence operation (if the operation dates back more than 6 months)
Key exclusion criteria (8 listed)
- Intolerance against a substance or a compound
- participation in an other study 4 weeks prior to inclusion
- urinary tract infection
- drug abuse
- bladder affecting drugs like anticholinergics, diuretics, muscle relaxing medicaments and phytotherapeutics
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 |
|---|---|---|
| Bryophyllum pinnatum 50 %, tablets into capsules (verum: 2x2capsules/day)Bryophyllum is administered for 3 weeks. Bryophyllum is given in form of capsules, 350mg per capsule, 0-0-2-2/d: 2 capsules 30min. before supper,2 capsules before going to bed. Other Names: Bryophyllum pinnatum/Kalanchoe | Drug | Bryophyllum pinnatum |
Primary outcome
Reduction of nocturia frequency
Time frame: 4 Weeks
micturition protocol will be handed over during the baseline visit, it will be filled three days before the second visit in 1 week( therapy-start), follow-up control 3 weeks after medication intake and after the completed medication period ]
Sleep-Quality.
Time frame: 4 Weeks
Pittsburgh Sleep Quality Index (PSQI; score 0-21) will be handed over during the baseline visit and will be filled three days before the second visit in 1 Week and three days after the therapy-end (after 3 Weeks). The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
3 secondary outcomes
Changes of overactive bladder symptoms
Time frame: before the second visit in 1 week, at follow-up control 3 weeks after begin of medication intake and 4 weeks after end of medication intake.
Safety of Bryophyllum: adverse events
Time frame: 4 weeks
Daytime sleepiness
Time frame: before the second visit in 1 week, at follow-up control 3 weeks after begin of medication intake and 4 weeks after end of medication intake.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bryophyllum pinnatum 50 %, tablets into capsules (verum: 2x2capsules/day) in people with Nocturia and Sleep Disorder, run by University of Zurich at 1 site 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction of nocturia frequency (time frame: 4 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2022.