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Trial record 14 of 15 for:    Passiflora

Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®

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ClinicalTrials.gov Identifier: NCT02651922
Recruitment Status : Completed
First Posted : January 11, 2016
Results First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Collaborator:
Institut für Empirische Gesundheitsökonomie, Prof. Dr. Dr.med. Reinhard Rychlik,Am Ziegelfeld 28,51399 Burscheid,Germany
Information provided by (Responsible Party):
Pascoe Pharmazeutische Praeparate GmbH

Brief Summary:
The study was carried out as a prospective, non-interventional study with the intention of subsequent process cost analyses (PCA) and also considers quality of life, drug misuse, dependence, adverse events and therapy satisfaction.

Condition or disease
Nervous Restlessness

Detailed Description:

The study was carried out as a prospective, non-interventional study with the intention of subsequent process cost analyses (PCA) and also considers quality of life, drug misuse, dependence, adverse events and therapy satisfaction. Data were collected in collaboration with 22 physicians in Germany.

The study was designed as a one armed non-interventional study. Patients had to suffer from nervous restlessness in order to be eligible for study documentation. Participants agreed to a medical treatment with PASCOFLAIR® of 12 weeks. In this context, documented patients could take PASCOFLAIR® at the first time or could have started within the past three months before the initial visit. Furthermore, documented patients had to be older than 18 years and must be able to read and understand the patient declaration of data protection and the declaration of consent. The patient must not be an alcoholic, must not be drug dependent and have no other types of addiction. Patients who were pregnant or breast-feeding were not eligible for study participation. Furthermore, patients showing hypersensitivity against passionflower extract or against other components of the medication were excluded. The signed declaration of consent of participating patients is available.

The treatment of affected patients may not be documented, if a redemption (written or spoken) of the declaration of consent is existing or the patient takes Benzodiazepines.


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Study Type : Observational
Actual Enrollment : 154 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®
Study Start Date : September 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015



Primary Outcome Measures :
  1. Change of Symptom Inner Restlessness (Pre - Post) [ Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) ]
    Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"


Secondary Outcome Measures :
  1. Change of Symptom Sleep Disturbance (Pre - Post) [ Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) ]
    Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

  2. Change of Symptom Exhaustion (Pre - Post) [ Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) ]
    Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

  3. Change of Symptom Fear (Pre - Post) [ Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) ]
    Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

  4. Change of Symptom Lack of Concentration (Pre - Post) [ Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) ]
    Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

  5. Change of Symptom Transpiration (Pre - Post) [ Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline ) ]
    Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

  6. Change of Symptom Nausea (Pre - Post) [ Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline) ]
    Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

  7. Change of Symptom Trembling (Pre - Post) [ Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline) ]
    Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

  8. Change of Symptom Palpation (Pre - Post) [ Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) ]
    Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

  9. Change of BDEPQ (Benzodiazepine Dependence Questionnaire) [ Time Frame: Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline) ]

    The Benzodiazepine Dependence Questionnaire (BDEPQ) is a 30 item self report questionnaire designed to measure dependence on benzodiazepine tranquilisers, sedatives and hypnotics. Items cover all aspects of the dependence syndrome with the exception of withdrawal symptoms. Each item is rated on a four point likert scale referring to experiences in the last month.

    BDEPQ score ranges from 0 (no dependence) to 85 (most severe dependence).


  10. Change of RS-13 (Resilience Questionnaire) (Pre - Post) [ Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) ]
    RS-13 is a 13 items self Report questionnaire measure the resilience, which applies a reliance scale ranging from 13 (lowest stress resistance) to 91 (highest stress resistance).

  11. Change in EQ-5D (Health Questionnaire) Scores (Pre - Post) [ Time Frame: Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline) ]
    EQ-5D™ is a standardised instrument for use as a measure of health Outcome The EQ-5D assesses five aspects of QoL: mobility, self-care, usual activity, pain/discomfort and anxiety/depression. An EQ-5D profile score of 0 points represents the worst QoL (death), while 1 point stands for full health. Data analysis was performed according to the EuroQol manual. The EQ-VAS ranges from 0 (worst QoL) to 100 (best QoL).

  12. Change of EQ-5D VAS Scores (Pre - Post) [ Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) ]
    VAS values (Quality of Life) range from 0 (very poor) to 100 (best possible state).

  13. Tolerability Assess Using a 5 Point Scale [ Time Frame: Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline) ]
    Assessment of tolerability using a 5 point scale (very good, good, satisfactory, bad, very bad)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients had to suffer from nervous restlessness in order to be eligible for study documentation.
Criteria

Inclusion Criteria:

  • patients suffering from nervous restlessness

Exclusion Criteria:

  • Age < 18 years and must be able to read and understand the patient declaration of data protection and the declaration of consent
  • alcoholics, drug pending, addictive disorder
  • pregnancy or lactating
  • patients showing hypersensitivity against passionflower extract or against other components of the medication

Layout table for additonal information
Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier: NCT02651922     History of Changes
Other Study ID Numbers: 199A14PF
First Posted: January 11, 2016    Key Record Dates
Results First Posted: June 19, 2017
Last Update Posted: June 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Pascoe Pharmazeutische Praeparate GmbH:
Nervous restlessness
Pascoflair
Passiflora incarnata
Benzodiazepine

Additional relevant MeSH terms:
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Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms