Effects of Intra-articular Hypertonic Dextrose and Hyaluronic Acid on Primary Knee Osteoarthritis. (NCT07102225) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Effects of Intra-articular Hypertonic Dextrose and Hyaluronic Acid on Primary Knee Osteoarthritis.
Bangladesh56 participantsStarted 2025-05-04
Plain-language summary
The aim of this study is to compare the effectiveness of intra-articular hypertonic dextrose and hyaluronic acid in managing pain and improving function in patients with primary knee osteoarthritis (KOA). This study will guide us to treat primary KOA patients with dextrose prolotherapy instead of hyaluronic acid more effectively.
Who can participate
Age range
40 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Knee OA diagnosis satisfying the American College of Rheumatology clinical and radiographic criteria, Kellgren-Lawrence grade of II and III determined by Postero-anterior knee radiograph.
* Participants will have the ability to undergo 3 months of follow-up
* Participants who will agree to avoid non-steroidal anti-inflammatory drugs during the research (acetaminophen will be prescribed for intractable pain)
Exclusion Criteria:
* Participants who will give a self-reported history of knee surgery, fracture, or infection.
* Kellgren-Lawrence grade IV KOA.
* Participants on anticoagulants.
* Participants who will have previous history of intra-articular knee injection of HA or prolotherapy within 6 months.
* Participants who have malignant disease or secondary KOA.
* Participants who will have a history of comorbid illness(es) like chronic heart failure, advanced COPD, end-stage renal failure, advanced liver disease and poorly controlled DM.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analog Scale (VAS)
Timeframe: Outcome 1: " VAS score at week 1", Outcome 2: "VAS score at week 4", Outcome 3: "VAS score at week 12",
2
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timeframe: Outcome 1: " WOMAC score at week 1", Outcome 2: " WOMAC score at week 4", Outcome 3: " WOMAC score at week 12"