Phase II Clinical Trial of Ayurved Siriraj Wattana Recipe for Symptomatic Relief in Patients with Osteoarthritis of the Knee
Thanyaporn Pengkhum MSc*, Somruedee Chatsiricharoenkul MD*, Pravit Akarasereenont MD*, Keerati Charoencholvanich MD**
Affiliation : * Department of Pharmacology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand ** Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
Background : Osteoarthritis of the knee is one of the most common public health problems in Thailand and throughout the
world. It causes disability, with pain and loss of function. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most
common treatment modality to relieve pain for OA, but can cause undesirable adverse effects. Effective and safer alternative
treatments for OA are urgently needed. Among the many kinds, Ayurved Siriraj Wattana Recipe has been widely used in
humans for a long time. The components of the recipe probably were related with many systems of the body such as the
immune system and the gastrointestinal system and it may have anti-inflammatory activity as well as anti-oxidative capacity.
Objective : Determine the efficacy of Ayurved Siriraj Wattana Recipe for knee osteoarthritis in a randomized, open-label,
diclofenac-controlled trial for 12 weeks. The trial has been approved from Siriraj Institutional Review Board (SIRB), Faculty
of Medicine, Siriraj Hospital, Mahidol University.
Material and Method: Analyze the 12-item Oxford, defined as 5-point Likert scales of pain and functional activity. The
secondary assessment included 10-cm VAS pain assessment tool as well as, patients’ and physician’s global efficacy assessment.
Results : “12-Item Oxford” revealed that patients had mild problems in terms of function and pain with an average function
score observed between groups (p = 0.6). The average pain score at 12 weeks’ follow-up was not significantly different in the
Wattana group compared with the diclofenac group (p = 0.3). Responses with no differences included the mean 10-cm VAS
that assessed pain at 12 weeks’ follow-up in both groups. There were no significant differences in the patients’ and physician’s
global efficacy assessment with patients in both groups. There were no differences in the frequent of adverse events between
groups. In addition, there were no significant differences in the patients’ and physician’s global safety assessment between
groups.
Conclusion : The present, diclofenac-controlled trial concludes that Ayurved Siriraj Wattana Recipe treatment could be an
effective treatment of pain in knee OA at 12 weeks.
Keywords : Ayurved Siriraj Wattana Recipe, Diclofenac, Osteoarthritis of the knee, Oxford knee score
