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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00010554 |
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Date of registration:
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29/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Influence of Junfeng BFS Water on Microcirculation
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Scientific title:
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Influence of Junfeng BFS Water on Microcirculation |
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Date of first enrolment:
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10/12/2016 |
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Target sample size:
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60 |
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Recruitment status: |
Pending |
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URL:
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http://drks.de/search/en/trial/DRKS00010554 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: placebo; Assignment: parallel; Study design purpose: Prognosis
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Dieter
Eisenmann |
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Address:
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Bahnhofstr. 42
7000
Chur
Switzerland |
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Telephone:
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+41-81-2584433 |
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Email:
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dr.d.eisenmann@gmail.com |
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Affiliation:
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Aiugenarztpraxis |
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Name:
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Dieter
Eisenmann |
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Address:
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Bahnhofstr. 42
7000
Chur
Switzerland |
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Telephone:
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+41-81-2584433 |
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Email:
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dr.d.eisenmann@gmail.com |
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Affiliation:
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Augenarztpraxis |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with Glaucoma
Patients with age-related macular degeneration
volunteers with healthy eyes
Exclusion criteria: Patients with multiple diseases or multiple medications
Patients with mental problems or dementia
Patients with congestive heart failure
Age minimum:
45 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary open-angle glaucoma
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Healthy volunteers
H40.1
H35.3
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Degeneration of macula and posterior pole
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H40.1
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H35.3
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Intervention(s)
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Group 1: 10 patients each with normal eyes, glaucoma and age-related macular degenration have to drink 2 liters of JBW over a period of 2 months. Eye examination with OCT and Pascal Dynamic Contour Tonometry are performed prior to the study, after 1 and after 2 months as well as interviews about well-being and acceptance of JBW. Blood tests (blood cells, haematocrit, fibrinogen, plasmaviscosity and c-reactive protewin) are done prior to drinking and after 2 months.
Group 2: 10 patients of the placebo-group each with normal eyes, glaucoma and age-related macular degenration have to drink 2 liters of intreated drinking water over a period of 2 months. Eye examination with OCT and Pascal Dynamic Contour Tonometry are performed prior to the study, after 1 and after 2 months as well as interviews about well-being and acceptance of JBW. Blood tests (blood cells, haematocrit, fibrinogen, plasmaviscosity and c-reactive protein) are done prior to drinking and after 2 months.
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Primary Outcome(s)
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- OCT at day 0, day 30 and day 60
- nd Pascal Dynamic Contour Tonometry at day 0, day 30 and day 60
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Secondary Outcome(s)
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Blood tests (blood cells, haematocrit, fibrinogen, plasmaviscosity and c-reactive protein) at day 0 and day 60.
Written formated Interviews at day 0. day 30 and day 60.
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Source(s) of Monetary Support
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Junfeng BFS Technology Co. Ltd.
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Ethics review
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Status: Approved
Approval date: 25/11/2016
Contact:
Kantonale Ethikkommission Zürich [Kantonale Ethikkommission Zürich
Stampfenbachstrasse 121
8090 Zürich
Tel. +41 (0)43 259 7972
Info.KEK@kek.zh.ch]
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