Intraocular Pressure Changes After Glucosamine Sulfate Consumption.Phase 3NCT02306083
Effect of Glucosamine on Intraocular Pressure
A Phase 3 study testing glucosamine sulfate 1500 mg three times a day in people with Intraocular Pressure Changes After Glucosamine Sulfate Consumption., run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure Changes After Glucosamine Sulfate Consumption.
- What is being tested?
- glucosamine sulfate 1500 mg three times a day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteIran
- Study dates
- Jul 2014to Jun 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of rheumatoid arthritis based on ACR (American College of Rheumatology)FC(functional classes).
- No history of using drugs tested in the study.
Who cannot join
- History of any kind of corneal surgery.
- History of intraocular surgery.
- History of diabetes mellitus.
- Heavy smokers.
- Unwillingness to participate in the study.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Islamic Republic OF Iran
Tehran
Mohammad Pakravan, MD, 009822591616, labbafi@hotmail.com
About this study
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.
- Being tested
- Placebo three times a day, glucosamine sulfate 1500 mg three times a day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo three times a dayDrug
Also called oral consumption
glucosamine sulfate 1500 mg three times a dayDrug
Also called oral consumption
| Study group | Role | What they receive |
|---|---|---|
| Administration of the Placebo | Placebo comparator | Placebo three times a day. Receives: Drug: Placebo three times a day |
| Administration of the glucosamine sulfate | Placebo comparator | glucosamine sulfate 1500 mg three times a day Receives: Drug: glucosamine sulfate 1500 mg three times a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure changes
: Goldmann applanation tonometry
Measured: until 6 months
Secondary outcomes (1)
corneal biomechanical changes
Ocular Response Analyzer (ORA)
Measured: until 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Pressure Changes After Glucosamine Sulfate Consumption.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306083
- Sponsor's protocol ID
- 92182
- Status last verified
- Mar 2014
- First submitted
- 25 Sep 2014
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glucosamine on Intraocular Pressure
- ClinicalTrials.gov ID
- NCT02306083
- Acronym / sponsor ID
- 92182
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of the Placebo | Placebo comparator | Drug: Placebo three times a dayPlacebo three times a day. |
| Administration of the glucosamine sulfate | Placebo comparator | Drug: glucosamine sulfate 1500 mg three times a dayglucosamine sulfate 1500 mg three times a day |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of rheumatoid arthritis based on ACR (American College of Rheumatology)FC(functional classes).
- No history of using drugs tested in the study.
Key exclusion criteria (5 listed)
- History of any kind of corneal surgery.
- History of intraocular surgery.
- History of diabetes mellitus.
- Heavy smokers.
- Unwillingness to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo three times a dayAlso: oral consumption | Drug | Administration of the Placebo |
| glucosamine sulfate 1500 mg three times a dayAlso: oral consumption | Drug | Administration of the glucosamine sulfate |
Primary outcome
Intraocular pressure changes
Time frame: until 6 months
: Goldmann applanation tonometry
1 secondary outcome
corneal biomechanical changes
Time frame: until 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing glucosamine sulfate 1500 mg three times a day in people with Intraocular Pressure Changes After Glucosamine Sulfate Consumption., run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Pakravan, MD (009822591616, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure changes (time frame: until 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015; AzTrials last refreshed its copy on 6 Nov 2026.