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Effects of Intra-articular Hypertonic Dextrose and Hyaluronic Acid on Primary Knee Osteoarthritis.

NCT07102225 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-08-03

No results posted yet for this study

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.

Conditions

  • Mild to Moderate Knee OA

Interventions

DRUG

prolotherapy solution of 20% dextrose

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

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.

Sponsors & Collaborators

  • Bangladesh Medical University

    lead OTHER

Principal Investigators

  • Farzana Khan Shoma, MBBS, FCPS · Bangladesh Medical University (formerly known as Bangabandhu Sheikh Mujib Medical University)

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-04
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07102225 on ClinicalTrials.gov