Journal of Mazandaran University of Medical Sciences (Jun 2024)
Investigating the Clinical Effect of Arthrohil Lipogel on Osteoarthritis Patients: A Double-Blind Randomized Clinical Trial Study
Abstract
Background and purpose: Osteoarthritis is the most common joint disease in humans, the main symptoms of which are joint pain and dryness. On the other hand, the knee is the most common joint affected by osteoarthritis. The main goals in the treatment of this disease are to reduce pain restore function and improve the patient's quality of life. In many parts of the world, non-steroidal anti-inflammatory drugs are used as the first-line treatment for osteoarthritis. However, researchers are still investigating herbal and alternative treatments. Therefore, this research aimed to make a local herbal lipogel that can be effective in improving the symptoms of osteoarthritis. Materials and methods: This study was a double-blind randomized clinical trial study. Seventy patients were randomly selected from those who were referred to the rheumatologist's office and were diagnosed with osteoarthritis and ruled out systemic rheumatism diseases by observing the entry and exit criteria. The patients had been referred to the doctor for the treatment of 1st and 2nd-degree osteoarthritis and after explaining to them the objectives of the study, after obtaining written consent, they entered the study and were divided into two groups receiving lipogel Arthrohil (35 people) and receiving lipogel placebo (35 people) were divided. To prepare plastic base gel, first, 5% low-density polyethylene (LDPE) was added in 95% liquid paraffin and it was indirectly heated at 130°C for three hours. Then we cooled it very quickly to form a plastic base gel. The gel obtained from Plastibase was investigated in terms of physical stability in ambient and refrigerator temperatures, in terms of occurrence of turbidity, syneresis phenomenon, appearance change of consistency, and pH. The extracts of each of the plants Turmeric (2%), Betula (4%), and Marmaki (4%) were added separately to the gel base and mixed until the gel reached the appropriate consistency. Lipogel was used topically for two months twice a day each time in the amount of two knuckles on each joint. The results of the WOMAC and VAS questionnaires were collected before the treatment, at the end of the first month, and the end of the second month after the treatment. The significance level of the tests was considered P<0.05. Results: The studied patients were in the age range of 40 to 73 years. The prepared herbal lipogel can be used for clinical tests in terms of microbial control and it contained 0.03% of total flavonoid and 0.1027% of total phenol. The stability of herbal lipogel was more than 94%. According to the WOMAC questionnaire, compared to placebo, herbal lipogel significantly reduced pain, joint stiffness, and movement disorder in osteoarthritis patients (P<0.05). The results of the Friedman test, to compare the scores of the VAS questionnaire before the start of the treatment, at the end of the first month, and at the end of the second month showed that after the treatment with herbal lipogel, the amount of pain felt by the patients decreased significantly (P<0.05). Conclusion: By comparing the scores obtained from the WOMAC and VAS questionnaires in the placebo and herbal lipogel groups, we found that the topical use of herbal lipogel has been effective in increasing the performance and pain control of patients with osteoarthritis, which is due to the antioxidant and anti-inflammatory properties of the compounds. In this lipogel, it seems obvious. (Clinical Trials Registry Number: IRCT201609143014N14)
