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Study on Apocynin and Paeonol for Knee Osteoarthritis Pain Relief in Adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for knee osteoarthritis, a common condition that causes pain and stiffness in the knee joint. The treatment being tested is a combination of two substances, apocynin and paeonol, which are taken in the form of capsules known as APPA. The study will also involve the use of Panodil, a medication containing paracetamol, and a matching placebo.

The purpose of the study is to evaluate how the treatment affects pain in the knee. Participants will be randomly assigned to receive either the APPA capsules, Panodil, or a placebo. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure that the results are not influenced by expectations. The study will last for a period of 12 weeks, during which participants will take the assigned treatment and attend regular check-ups to monitor their progress.

Throughout the study, participants will be asked to report on their knee pain and any changes they experience. The main focus will be on changes in pain levels, but other aspects such as knee function and overall quality of life will also be assessed. The goal is to determine if the combination of apocynin and paeonol can provide relief from the symptoms of knee osteoarthritis and improve the daily lives of those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be informed about the trial's purpose and procedures. The participant must provide written consent after understanding the study material.
Eligibility criteria include being between 40 and 85 years old, having knee osteoarthritis, and meeting specific pain and radiographic criteria.
Step 2
Randomization and medication
Participants will be randomly assigned to receive either the combination of apocynin and paeonol (APPA), paracetamol, or a placebo. The medication will be administered orally in the form of capsules or film-coated tablets.
The dosage and frequency of administration will be determined by the study protocol, and participants will be required to take the medication as instructed for the duration of the trial.
Step 3
Treatment period
The treatment period will last for 12 weeks. During this time, participants will continue taking the assigned medication and attend scheduled evaluations to monitor progress and any side effects.
Participants will be asked to report any use of rescue medication for knee pain and any changes in their condition.
Step 4
Evaluation and monitoring
Throughout the trial, participants will undergo regular assessments to evaluate changes in knee pain and overall health. This includes measuring pain scores, function, stiffness, and quality of life.
Safety assessments will include monitoring laboratory parameters, vital signs, and any adverse events.
Step 5
Completion of the trial
At the end of the 12-week period, participants will have a final evaluation to assess the primary and secondary outcomes of the trial.
The primary outcome is the change in knee pain from the start of the trial, while secondary outcomes include changes in function, stiffness, and quality of life.

Who can join the trial?

7 criteria

The participant must be able to read and understand the study materials, follow the study requirements, and agree to provide information during scheduled evaluations. They must also give written consent to participate.
The participant's age should be between 40 and 85 years old.
The participant must have **femorotibial osteoarthritis** of the knee. This means they have a specific type of knee arthritis diagnosed by certain clinical and X-ray criteria.
The X-ray of the knee should show a **grade 2 or 3** osteoarthritis according to the **Kellgren-Lawrence method**. This is a way to measure the severity of arthritis using X-rays.
The participant's knee pain score, measured by a tool called **WOMAC**, should be between 25 and 44 out of 50. This score is based on answers to 5 questions about knee pain.
The participant should have a **PainDETECT** score of 13 or higher out of 38. This is a questionnaire that helps assess the type of pain the participant is experiencing.
The participant must have tried at least one treatment for osteoarthritis, such as physiotherapy, pain relievers like paracetamol, anti-inflammatory drugs, short-term opioid use, or injections, and found it either ineffective or intolerable.

Who cannot join the trial?

8 criteria

Patients who have had surgery on the knee that is being studied.
Patients who have received injections in the knee that is being studied within the last 6 months.
Patients with a history of allergic reactions to the study medication.
Patients with other significant joint diseases that affect the knee being studied.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial.
Patients with severe medical conditions that could interfere with the study.
Patients who are unable to follow the study procedures.

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Sanos A/S
Gandrup, Denmark

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Investigated drugs

Apocynin
is a medication being studied for its potential to reduce inflammation and pain in the knee. It is being tested to see if it can help people with knee osteoarthritis feel less pain and improve their knee function.
Paeonol
is another medication included in the study. It is being evaluated for its ability to work alongside apocynin to further reduce pain and inflammation in the knee, potentially providing additional relief for those suffering from knee osteoarthritis.
APPA
is a combination of apocynin and paeonol. This combination is being tested to determine if using both medications together is more effective in reducing knee pain and improving joint function than using either medication alone.

What is already known about the treatment

APPA – APPA is a combination medication consisting of apocynin and paeonol, currently being studied for its potential to treat knee osteoarthritis. It is administered orally in the form of tablets. The main therapeutic indication for APPA is to alleviate pain associated with knee osteoarthritis. At the molecular level, apocynin is believed to reduce inflammation by inhibiting the production of reactive oxygen species, while paeonol may have anti-inflammatory and analgesic effects. APPA is classified under anti-inflammatory and analgesic agents. The medication is currently in clinical trials to determine its effectiveness and optimal dosage for pain relief in knee osteoarthritis patients.

Investigated diseases

Knee Osteoarthritis – Knee osteoarthritis is a degenerative joint disease characterized by the breakdown of cartilage in the knee joint. This condition leads to pain, stiffness, and swelling, which can worsen over time. As the cartilage wears away, bones may rub against each other, causing increased discomfort and reduced mobility. The progression of knee osteoarthritis can vary, with some individuals experiencing gradual worsening of symptoms. Factors such as age, weight, and previous joint injuries can influence the development and progression of the disease. Regular physical activity and maintaining a healthy weight can help manage symptoms and slow progression.