Last updated on February 2018

Chronic Widespread Pain and White Blood Cell Activation

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Widespread Chronic Pain
  • Age: Between 14 - 18 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Female and male adolescents aged between 14 to 18 years old;
  • For female adolescents of child bearing potential: negative serum pregnancy test at base line screening;
  • For female adolescents of child bearing potential: being willing and able to use contraceptive methods for the duration of the study and for 30 days after receiving the last dose of the study drug;
  • Diffuse body pain that has been present for at least 3 months, and who also have symptoms of fatigue, sleep disturbance, cognitive changes and mood disorder;
  • Accompanied by at least one somatic symptoms to variable degree including irritable bowel syndrome, headaches, menstrual pain, lower urinary tract symptoms, myofascial pain, and temporomandibular pain;
  • Symptoms cannot be explained by some other illness;
  • Physical examination which should be within normal limits except for tenderness on pressure of soft tissues (i.e. tactile hyperalgesia which is increased pain following a painful stimulus)
  • Overall body pain average score 4
  • Moderate to severe physical impairment Functional Disability Inventory > 12 points.
  • Stable doses of his/her current medication for at least four weeks
  • Not having significant changes in their health conditions (PIGS less than 6 points) after 8 weeks of treatment

Exclusion Criteria:

  • Be part of other trials;
  • Have a specific diagnosis that can explain the symptoms; including rheumatoid arthritis, systemic lupus erythematosus, scleroderma and/or other connective tissue diseases
  • Refuse to donate blood sample;
  • Not be able to fill electronic records;
  • Cognitive impairment interfering with the clinical evaluations;
  • Known intolerance or allergies to KF;
  • Been under treatment with other mast cell stabilizer agent;
  • Seizures history or actual treatment;
  • Coagulopathies or chronic thrombocytopenia;
  • Atopic dermatitis (eczema) or chronic urticaria (hives)
  • Schizophrenia or bipolar disorder
  • Elective surgery within the study timeline
  • Abnormal labs results (i.e., elevated SGPT and low platelet count, low Hb or Ht) in the last 6 months or in the base line evaluation
  • Patients who are pregnant or are breast-feeding;
  • Patients who are on oral antidiabetic agents;

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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