Safety and Efficacy of Sahasthara ME vs Diclofenac ME for Treating Primary Knee Osteoarthritis
Condition: Primary Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      Background: Sahasthara is a traditional Thai herbal remedy used for the anti-inflammatory
      treatment of the musculoskeletal system, while diclofenac sodium is one of the most topically
      administered anti-inflammatory drug. However, there has not been scientifically researched
      regarding the efficacy and safety of SHT formulated as ME.

      Purpose: To assess the safety and effectiveness of Sahasthara microemulsion (SHT-ME) in
      comparison to a diclofenac microemulsion (DF-ME) in treating primary osteoarthritis (OA) of
      the knee.

      Methods: A randomized, double blinded clinical trial phase II was conducted. One treatment
      group received 1% SHT-ME, while the other received 2% DF-ME (2 ml, 3 times per day for 28
      days) on their affected knee area. All patients were followed up at 14 and 28 days. Changes
      in the visual analogue scale (VAS) for pain as well as 100-meter walking times, the WOMAC
      index scores, and a global assessment were examined for efficacy. Clinical examinations,
      abnormalities in laboratory tests, and the incidence of adverse events (AEs) were assessed
      for safety.
    

Detailed description: 
      Outpatient participants, aged between 40 - 70 years old, were recruited. They were screened
      for symptoms of primary knee OA at the Department of Orthopedics, Thammasat University
      Hospital, Pathum Thani, Thailand, between October - December 2021. A diagnosis of knee OA in
      this clinical trial were made with a combination of clinical and radiographic findings
      according to the American College of Rheumatology (ACR). Inclusion criteria for participants
      were those who had a pain score higher than 30 mm out of 100 mm on the visual analog scale
      (VAS), experiencing moderate to severe pain intensity from OA in one or both knees (patients
      who affected by knee OA bilaterally were evaluated, which more severely affected knee was
      included in the study) and had OA grade 1 to 3 (moderate/medium degree of pain) according to
      the Kellgren-Lawrence classification grading scale for OA severity. The subjects would be
      excluded if they: 1) had a history of hypersensitivity to ingredients in SHT ME or DF-ME, 2)
      were pregnant or breast feeding, 3) had previous surgery knee replacement or intra-articular
      steroid injections within 3 months of inclusion in the study, 4) were having any coexisting
      musculoskeletal diseases (including rheumatoid arthritis, septic arthritis, metabolic
      arthritis, gout, pseudogout, and traumatic arthritis ) or dermatologic disorder which
      affected the surrounding skin of the knees, or 5) was assessed by body mass index (BMI) more
      than 32 kg/m2. The participants who were accepted to enroll in the study signed an informed
      consent.

      Following enrollment, eligible patients were given a washout period of one week with no
      administration of analgesics before being randomly assigned to receive one of the treatments
      daily for 4 weeks. A randomized code number from a non-stratified randomization list
      generated by computer was used. The physicians, researchers, and statisticians were blinded
      from the allocation of patients involved in the trial. During the study, they were instructed
      not to use other analgesics, including injection drugs or other medications. Following the
      baseline visit, patients returned to the study site after 2 and 4 weeks for follow-up
      assessments of safety, efficacy and study protocol compliance.

      In the trial, demographic data, clinical signs and symptoms, physical examination, visual
      analogue scale (VAS) for pain, 100-meter walk times, the WOMAC index scores (pain, physical
      function, stiffness), and laboratory tests (fasting blood sugar, lipid profile, liver
      function tests (AST, ALT, ALP), and renal function tests (BUN, creatinine clearance)) were
      collected as baseline data and as study data on day 14 and on day 28
    

Intervention name(s): Sahasthara Microemulsion; Diclofenac Microemulsion
Intervention type(s): Drug; Drug
Intervention description(s): All patients were instructed to treat the knee with 2 ml, 3x/day, for 28 days. Each of the patients received the same appearance of drug packaging, which was not revealed until data analysis was completed, or medical emergency conditions would require an unblinding.; All patients were instructed to treat the knee with 2 ml, 3x/day, for 28 days. Each of the patients received the same appearance of drug packaging, which was not revealed until data analysis was completed, or medical emergency conditions would require an unblinding.
Other intervention name(s): Diclofenac Microemulsion
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clinical; Topical; Microemulsion; Sahasthara; Diclofenac; Knee Osteoarthritis