- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04480658
Effectiveness of Bryophyllum in Nocturia-Therapy
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zurich, Switzerland, 8091
- University of Hospital, Clinic for Gynecology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bryophyllum pinnatum
Bryophyllum pinnatum (BP) muscle relaxing substance
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 ]
|
4 Weeks
|
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.
|
4 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
quality of life is measured by the ICIQ-OAB (score 0-16), a specific questionnaire for OAB
|
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
|
during medication intake at 1 week and 3 weeks after start of medication intake, measured by a personal adverse event protocol
|
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.
|
quality of life is measured by Epworth Sleepiness Scale Questionnaire (score 0-24)
|
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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-01964
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep Disorder
-
Matrouh UniversitySuez Canal University; Beni-Suef University; University of Bisha, Saudia ArabiaCompletedSleep Disorder | Sleep Hygiene | Sleep Disorder; Insomnia Type | Sleep Disorder in Elderly | Sleep Disorder, Mental Health | Sleep Disorders, Physical HealthEgypt
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)CompletedSleep Disorder | Diarrhea | Anxiety Disorders | Insomnia | Sleep Initiation and Maintenance Disorders | Anxiety | Sleep Disturbance | Gastrointestinal Dysfunction | Heartburn | Caffeine | Caffeine Withdrawal | Caffeine; Sleep Disorder | Caffeine Dependence | Caffeine-Induced Anxiety Disorder | Caffeine-Induced Sleep... and other conditionsUnited States
-
Johannes Gutenberg University MainzRecruitingSleep Disorder | Restless Legs Syndrome | Insomnia | Sleep Apnea | Narcolepsy | Idiopathic Hypersomnia | Somnambulism | Sleep Disorder Parasomnia | REM Behavior DisorderGermany
-
Yale UniversityCompletedCircadian Rhythm Sleep Disorder, UnspecifiedUnited States
-
The University of Texas Health Science Center,...Active, not recruitingRapid Eye Movement Sleep Behavior DisorderUnited States
-
Merck Sharp & Dohme LLCCompletedDyssomnias | Sleep Disorders | Mental Disorder | Sleep Initiation and Maintenance Disorder; Elderly | Sleep Disorder, Intrinsic
-
Vanda PharmaceuticalsRecruitingSleep Disorder | Sleep Disturbance | Autism Spectrum Disorder | Neurological DisorderUnited States
-
Assistance Publique Hopitaux De MarseilleAix Marseille UniversitéRecruitingREM Sleep Behaviour DisorderFrance
-
Yale UniversityNational Heart, Lung, and Blood Institute (NHLBI)RecruitingCritical Illness | Sleep Deprivation | Circadian Rhythm Sleep Disorder, UnspecifiedUnited States
-
Federal University of Minas GeraisHarvard Medical School (HMS and HSDM)Active, not recruitingDepressive Disorder | Quality of Life | Sleep Disorder | Anxiety Disorders | Insomnia | Spirituality | Stress Disorder | Insomnia Chronic | Insomnia Disorder | Complementary TherapyBrazil
Clinical Trials on Bryophyllum pinnatum 50 %, tablets into capsules (verum: 2x2capsules/day)
-
Markus SchlemmerRecruitingAnxiety SymptomsSwitzerland