Effectiveness of Bryophyllum in Nocturia-Therapy

NCT04480658 | Completed DMC

• 1 other identifier: 2017-01964
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Nocturia; Sleep Disorder

Outcome Measures

Primary Outcomes (2)

• 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 \]

  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.

  4 Weeks

Secondary Outcomes (3)

• Changes of overactive bladder symptoms

  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

  4 weeks

• Daytime sleepiness

  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.

Study Arms (1)

Bryophyllum pinnatum

EXPERIMENTAL

Bryophyllum pinnatum (BP) muscle relaxing substance

Drug: Bryophyllum pinnatum 50 %, tablets into capsules (verum: 2x2capsules/day)

Interventions

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

Bryophyllum pinnatum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Intolerance against a substance or a compound
• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University of Hospital, Clinic for Gynecology

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Nocturia; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 21, 2020
• Study Start: January 1, 2018
• Primary Completion: February 18, 2021
• Study Completion: January 14, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CH (1)