Clinical trial: Green Tea Lozenges for the Management of Dry Mouth (NCT01647737)

Eligibility criteria:
Inclusion Criteria:

          1. A complaint of dry mouth as assessed by a response of 30mm or greater on a Dry Mouth
             Visual Analog Scale (VAS)

          2. Clinical Diagnosis of primary or secondary Sjogren's syndrome.

          3. Over the age of 18.

          4. Taking less than three drugs associated with causing xerostomia or salivary gland
             hypofunction.

          5. Willing to use natural novel topical dry mouth products.

          6. Prior minor salivary gland biopsy and serology from Sjogren's Syndrome/Xerostomia
             work-up.

          7. Willing to return for all study-associated visits.

          8. Able to read, understand, and sign the informed consent.

        Exclusion Criteria:

          1. Have received radiation to the head and neck region.

          2. Unable to read and understand the consent form.

          3. On greater than three drugs associated with xerostomia or salivary gland hypofunction.

          4. Require dento-alveolar surgery or extensive dental treatment during the course of the
             study.

          5. Require hospitalization for any medical problem during the course of the study.

          6. Unable to take green tea leaf extract and/or pilocarpus jaborandi leaf extract and/or
             xylitol because of allergy

          7. Uncontrolled medical conditions that require changes in medication during the course
             of the study.

          8. Regularly consume green tea and/or components of pilocarpus jaborandi.

          9. Are pregnant
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? Entailment