Effect of Glucosamine on Intraocular Pressure | NCT02306083

Studies
Effect of Glucosamine on Intraocular Pressure

NCT02306083

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Unknown status

Last Update Posted

May 8, 2015Estimated

Enrollment

41Estimated

Phase

Phase 3

Conditions

Intraocular Pressure Changes After Glucosamine Sulfate Consumption.

Interventions

Placebo three times a day
glucosamine sulfate 1500 mg three times a day

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Jun 2015Estimated

Completion Date

Not provided

First Submitted Date

Sep 25, 2014

First Submission Date that Met QC Criteria

Nov 29, 2014

First Posted Date

Dec 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2015

Last Update Posted Date

May 8, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zahra Rabbani Khah, clinical professor ,ophthalmic research center, Shahid Beheshti University of Medical SciencesPrincipal Investigator

Lead Sponsor

Shahid Beheshti University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Administration of the Placebo	Placebo Comparator	Placebo three times a day.	Drug: Placebo three times a day
Administration of the glucosamine sulfate	Placebo Comparator	glucosamine sulfate 1500 mg three times a day	Drug: glucosamine sulfate 1500 mg three times a day

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo three times a day	Drug		Administration of the Placebo	oral consumption

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraocular pressure changes	: Goldmann applanation tonometry	until 6 months

Secondary Outcomes

Measure	Description	Time Frame
corneal biomechanical changes	Ocular Response Analyzer (ORA)	until 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammad Pakravan, MD	Contact	009822591616		labbafi@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Islamic Republic OF Iran	Recruiting	Tehran			Iran

Intervention Browse Module

MeSH Terms

ID	Term
D004467	Economics
D005944	Glucosamine

Ancestor Terms

ID	Term
D004472	Health Care Economics and Organizations
D006595	Hexosamines
D000606	Amino Sugars
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided