Efficacy and Safety of Sri Lankan Traditional Medicine Regimen for Knee Osteoarthritis: Study protocol for an open label randomized controlled trial
Authors: De Silva Himalee , Perera Pathirage Kamal , Jayasinghe Saroj 
Published: March 2022

Abstract
BackgroundOsteoarthritis (OA) has become a burden globally for the healthcare sector due to its high prevalence and incidence. Among that Knee Osteoarthritis (KOA) is the most common form of arthritis causing disability and impaired quality of life especially in elderly. Currently pharmacological, non-pharmacological and surgical measures are considered in treatment of OA with aims of reducing pain and improving function of the knee joint but currently there is no known cure and no interventions available to stop the progression or manage the symptoms with an acceptable benefit to harm profile. Traditional and Complementary Medicine (T&CM) is used not only to treat diseases, especially chronic diseases like OA, it is also widely used in disease prevention, health promotion and health maintenance, and it has proved to be cost effective for some governments. In Sri Lanka, Sri Lankan Traditional Medicine (STM) which is probably the oldest form of treatment used in the country specially for joint related disorders including OA. STM regimens are widely used to treat OA but no clinical trial evaluated on STM regimens for KOA to discuss their safety and efficacy in the treatment of KOA but most of the clinical trials evaluated on herbal preparations as single interventions. The aim of this study is to compare the efficacy and safety of Sri Lankan Traditional Medicine Regimen which include a decoction, pill, herbal fomentation and a paste for Knee Osteoarthritis in comparison to recommended conventional pain management therapy over a period of 8 weeks on relieving the condition of KOA. Study DesignThis is a two months clinical trial following a protocol driven open labeled randomized controlled study enrolling patients with KOA. Rasnadvigunabhagasaya decoction (RDBD) prepared from parts of 26 different plants that are used in traditional medicine for a variety of purposes such as reduction of pain, reduction of inflammation, and antipyretic activity, is one of the test products. While administrating internally, usually it was advised to given along with ginger powder or long pepper powder or with Yogaraja Guggulu or Ajamoda powder or castor oil. Yoaraja Guggulu was selected for this study as the recue medication based on its frequent usage in Sri Lankan Traditional Medicine for treating joints disorders it was which was co prescribed for the Rasnadvigunabhagasaya decoction. The efficacy and safety of the two Ayurvedic dosage forms will be tested against the non-steroidal anti-inflammatory drugs (NSAIDS) Tab Paracetamol and Tablet Ibuprofen as the rescue medication. As test products for external application, two preparations were selected from rewritten ola leaves and print as Thalpathe Pillium Book Series. The form of fomentation (Thevili Pottani with Oil application) contained 10 ingredients of herbal ball and dip in five types of oil mixture (Pasthel): Kumburuetaperumkayam Pottani (KAP) and paste (Paththu/Lepa): Sandivadam Lepaya (SVL) consist of 15 ingredients were selected. The efficacy and safety of these two external applications will be tested against the Diclofenac sodium gel and hot water fomentation. Patients with symptoms of Knee OA will be allocated randomly into two arms and the medications will be given orally for 60 days and externally for 30 days. The primary endpoint is a change in the score on the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) after 12 weeks. WOMAC and KOOS will be recorded and compared between the two arms prior to visit 1, at the end of 15 days and end of 30 days, and end of the 45 days and end of second month and three months of follow- up. WOMAC subscales, a pain disability index, a visual analog scale for pain and sleep quality, a quality-of-life index are used as secondary outcome measurements.DiscussionThis clinical trial will be able to provide evidence based scientific data on Sri Lankan Traditional Medicine regimen, RDBD with Yogaraja Guggulu, KAP and SVL in the management of Knee OA. This trial is expected to develop capacity to scientifically evaluate various Sri Lankan traditional Medicines that are claimed to have efficacy in treatment of various disease conditions. Trial RegistrationISRCTN58050062: https://doi.org/10.1186/ISRCTN58050062