Effect of Glucosamine on Intraocular Pressure

NCT ID: NCT02306083

Last Updated: 2015-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Brief Summary

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In this double blind clinical trial 92 patients suffering from rheumatoid arthritis are included. Those with the history of intraocular and corneal surgery, diabetic and heavy smokers are excluded from the study. Before starting the treatment all patients undergo complete ophthalmic exam, corneal biomechanical properties assessment by Ocular Response Analyzer (ORA) and corneal thickness measurement. Patients are randomly assigned to treatment and placebo groups. Those in the treatment groups receive glucosamine sulfate 1500 mg three times a day. Those in placebo arm receive alike capsule with the same schedule. At month 3 and 6 IOP(intraocular pressure), ORA and pachymetry would be checked again.

Detailed Description

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Conditions

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Intraocular Pressure Changes After Glucosamine Sulfate Consumption.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Administration of the Placebo

Placebo three times a day.

Group Type PLACEBO_COMPARATOR

Placebo three times a day

Intervention Type DRUG

Administration of the glucosamine sulfate

glucosamine sulfate 1500 mg three times a day

Group Type PLACEBO_COMPARATOR

glucosamine sulfate 1500 mg three times a day

Intervention Type DRUG

Interventions

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Placebo three times a day

Intervention Type DRUG

glucosamine sulfate 1500 mg three times a day

Intervention Type DRUG

Other Intervention Names

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oral consumption oral consumption

Eligibility Criteria

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Inclusion Criteria

* History of rheumatoid arthritis based on ACR (American College of Rheumatology)FC(functional classes).
* No history of using drugs tested in the study.

Exclusion Criteria

* History of any kind of corneal surgery.
* History of intraocular surgery.
* History of diabetes mellitus.
* Heavy smokers.
* Unwillingness to participate in the study.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahra Rabbani Khah

clinical professor ,ophthalmic research center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Islamic Republic OF Iran

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Mohammad Pakravan, MD

Role: CONTACT

009822591616

Facility Contacts

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Mohammad Pakravan, MD

Role: primary

009822591616

Other Identifiers

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92182

Identifier Type: -

Identifier Source: org_study_id

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