To Assess the Lanconone® (E-OA-07) Efficacy in Physical Activity-related Pain- LEAP Study
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The current study is designed to assess the pain relieving effect of 4-weeks ingestion of
      this commercialized dietary supplement (Lanconone®, Enovate Biolife, LLC, 1000 mg twice per
      day) in mild to moderate OA subjects. Also, the current study intends to assess the safety
      and efficacy of long term administration of Lanconone in larger sample size as compared to
      the earlier studies.15,16 The study also intends to analyse the effect on joint stiffness and
      function by means of self-reported WOMAC & Lequesne questionnaire.The effect of IP on
      clinically proven biomarker, hs-CRP will be analyzed in comparison with placebo.
    

Detailed description: 
      This study has been planned to evaluate the efficacy of Lanconone® in enhancing the overall
      joint health in the population of ≥ 40 years of age during the daily life activities by the
      reduction of the joint pain and discomfort. Assessment of pain is the primary objective which
      will be done by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
      It is a widely used, proprietary set of standardized questionnaires used by health
      professionals to evaluate the severity of osteoarthritis of the knee and hip, including pain,
      stiffness, and physical functioning of the joints. The early onset of action (3 days after
      commencement of the IP administration) for pain relief which was not captured in the past
      studies, will be captured in the current study by the telephonic assessment of the study
      subjects. Lequesne et al developed an index of severity for osteoarthritis for the knee which
      can be used to assess the effectiveness of therapeutic interventions. Unlike the earlier
      studies, we will use the Lequesne Functional Index (LFI) to assess the extent of joint health
      degeneration. In relation to OA, elevated levels of hs-CRP have been correlated with symptoms
      of joint pain and stiffness. Hence, we decided to analyze the hs-crp levels as one of the
      secondary objectives. Also, the rescue medication consumption has been limited to lower per
      day consumption compared to earlier studies to avoid the placebo effect influence on the
      study results. The efficacy of the IP in sustaining the pain relieving effect will be
      analyzed on day 35, i.e. one week after the end of the treatment.
    

Intervention name(s): Lanconone; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): . Lanconone® is a joint pain supplement containing natural herbs such as Shyonak, Ashwagandha, Shunthi, Guggul, Chopchini, Rasna and Shallaki in therapeutic quantities and documented in the ancient scriptures as pain relievers.; Microcrystalline cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, parallel group study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee OA; Joint Pain; Dietary supplement; WOMAC; Lequesne index; hs-CRP