Mild to Moderate Knee OAPhase 3NCT07102225
Effects of Intra-articular Hypertonic Dextrose and Hyaluronic Acid on Primary Knee Osteoarthritis.
A Phase 3 study testing prolotherapy solution of 20% dextrose and Hyaluronic Acid (HA) in people with Mild to Moderate Knee OA, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Mild to Moderate Knee OA
- What is being tested?
- prolotherapy solution of 20% dextrose and Hyaluronic Acid (HA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBangladesh
- Study dates
- 4 May 2025to 30 Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Bangladesh Medical University (formerly known as Bangabandhu Sheikh Mujib Medical University)
Dhaka, Shahbag, 1000
About this study
Official title: Effects of Intra-articular Hypertonic Dextrose and Hyaluronic Acid on Primary Knee Osteoarthritis: A Randomized Control Trial
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.
- Conditions
- Mild to Moderate Knee OA
- Being tested
- prolotherapy solution of 20% dextrose, Hyaluronic Acid (HA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prolotherapy solution of 20% dextroseDrug
This intervention is open label. Both participants and investigator will know about the intervention. Participants are allocated according to simple randomization by lottery. Two groups with each contain 28 participants. One group will be given a mixture of intra-articular injection of 5.6 ml 25% dextrose and 1.4 ml 2% lignocaine to achieve a final concentration 20% dextrose with 0.4% lignocaine in the involved knee joint. Another group will be given 1.4 ml 2% lignocaine followed by 2 ml high molecular weight hyaluronic acid intra-articularly in the involved joint.
Hyaluronic Acid (HA)Drug
This intervention is open label. Both participants and investigator will know about the intervention. Participants are allocated according to simple randomization by lottery. Two groups with each contain 28 participants. One group will be given a mixture of intra-articular injection of 5.6 ml 25% dextrose and 1.4 ml 2% lignocaine to achieve a final concentration 20% dextrose with 0.4% lignocaine in the involved knee joint. Another group will be given 1.4 ml 2% lignocaine followed by 2 ml high molecular weight hyaluronic acid intra-articularly in the involved joint.
| Study group | Role | What they receive |
|---|---|---|
| Effects of intra-articular hypertonic dextrose and hyaluronic acid on primary knee ostosteoarthritis | Experimental | To see the effectiveness of intra-articular hypertonic dextrose versus hyaluronic acid on primary knee OA Receives: Drug: prolotherapy solution of 20% dextrose; Drug: Hyaluronic Acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
VAS consisting of a 100mm long horizontal line, where 0 at one end indicates no pain and 100 at another end indicates worst pain. Number of participants will be assessed from baseline in pain scores on the Visual Analog Scale at 1, 4 and 12 weeks after treatment completion. Lower scores indicate better outcomes.
Measured: Outcome 1: " VAS score at week 1", Outcome 2: "VAS score at week 4", Outcome 3: "VAS score at week 12",
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
WOMAC is a questionnaire consisting of 24 items organized into 3 subscales like pain, stiffness and physical function that is used in patients with knee osteoarthritis. Total score ranges from 0 to 96, with higher scores indicating worse symptoms. Number of participants will be assessed from baseline on the WOMAC Scale at 1, 4 and 12 weeks after treatment completion. Lower scores indicate better outcomes.
Measured: Outcome 1: " WOMAC score at week 1", Outcome 2: " WOMAC score at week 4", Outcome 3: " WOMAC score at week 12"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start4 May 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Knee OAStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raju Dey, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Farzana Khan Shoma, MBBS, FCPS, Study director, Bangladesh Medical University (formerly known as Bangabandhu Sheikh Mujib Medical University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102225
- Sponsor's protocol ID
- 5506
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intra-articular Hypertonic Dextrose and Hyaluronic Acid on Primary Knee Osteoarthritis: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07102225
- Acronym / sponsor ID
- 5506
- Conditions
- Mild to Moderate Knee OA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 4 May 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 3 Aug 2025 (actual)
- 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effects of intra-articular hypertonic dextrose and hyaluronic acid on primary knee ostosteoarthritis | Experimental | Drug: prolotherapy solution of 20% dextrose, Drug: Hyaluronic Acid (HA)To see the effectiveness of intra-articular hypertonic dextrose versus hyaluronic acid on primary knee OA |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| prolotherapy solution of 20% dextroseThis intervention is open label. Both participants and investigator will know about the intervention. Participants are allocated according to simple randomization by lottery. Two groups with each contain 28 participants. One group will be given a mixture of intra-articular injection of 5.6 ml 25% dextrose and 1.4 ml 2% lignocaine to achieve a final concentration 20% dextrose with 0.4% lignocaine in the involved knee joint. Another group will be given 1.4 ml 2% lignocaine followed by 2 ml high molecular weight hyaluronic acid intra-articularly in the involved joint. | Drug | Effects of intra-articular hypertonic dextrose and hyaluronic acid on primary knee ostosteoarthritis |
| Hyaluronic Acid (HA)This intervention is open label. Both participants and investigator will know about the intervention. Participants are allocated according to simple randomization by lottery. Two groups with each contain 28 participants. One group will be given a mixture of intra-articular injection of 5.6 ml 25% dextrose and 1.4 ml 2% lignocaine to achieve a final concentration 20% dextrose with 0.4% lignocaine in the involved knee joint. Another group will be given 1.4 ml 2% lignocaine followed by 2 ml high molecular weight hyaluronic acid intra-articularly in the involved joint. | Drug | Effects of intra-articular hypertonic dextrose and hyaluronic acid on primary knee ostosteoarthritis |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Outcome 1: " VAS score at week 1", Outcome 2: "VAS score at week 4", Outcome 3: "VAS score at week 12",
VAS consisting of a 100mm long horizontal line, where 0 at one end indicates no pain and 100 at another end indicates worst pain. Number of participants will be assessed from baseline in pain scores on the Visual Analog Scale at 1, 4 and 12 weeks after treatment completion. Lower scores indicate better outcomes.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Outcome 1: " WOMAC score at week 1", Outcome 2: " WOMAC score at week 4", Outcome 3: " WOMAC score at week 12"
WOMAC is a questionnaire consisting of 24 items organized into 3 subscales like pain, stiffness and physical function that is used in patients with knee osteoarthritis. Total score ranges from 0 to 96, with higher scores indicating worse symptoms. Number of participants will be assessed from baseline on the WOMAC Scale at 1, 4 and 12 weeks after treatment completion. Lower scores indicate better outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Mild to Moderate Knee OA
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.
Farzana Khan Shoma, MBBS, FCPS study director
Bangladesh Medical University (formerly known as Bangabandhu Sheikh Mujib Medical University)
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 prolotherapy solution of 20% dextrose and Hyaluronic Acid (HA) in people with Mild to Moderate Knee OA, run by Bangladesh Medical University at 1 site in Bangladesh.
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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2025. 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 Bangladesh. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Outcome 1: " VAS score at week 1", Outcome 2: "VAS score at week 4", Outcome 3: "VAS score at week 12",). The study lists 2 primary outcomes in all. 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 3 Aug 2025.