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临床试验/CTRI/2012/03/002532
CTRI/2012/03/002532招募中2 期

Clinical Evaluation of Maha Triphaladya Ghrita in the Management of Dry Eye Syndrome (Shushkakshipaka). - IMCRP- DES-2010-2011

Central Council for Research in Ayurvedic Sciences CCRAS0 个研究点目标入组 150 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
150

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Patients presenting with signs and symptoms of Dry eye syndrome.
  • Schirmer-I test positive i.e.Ã? < 10 mm.
  • Tear film break-up time less than 10 seconds.Ã?
  • Rose Bengal staining showing devitalized epithelium of conjunctiva and mucus plaques on the cornea.Ã?
  • (If Any two of the above three criteria are present; the diagnosis of Dry Eye Syndrome is confirmed)
  • 2. Willing and able to participate in the study for 16 weeks.

排除标准

  • 1. Severe cases of dry eye syndrome with complications like perforated corneal ulcer, Uveitis, Glaucoma.
  • 2. Inflammatory conditions like acute conjunctivitis etc.
  • 3. Systemic diseases causing Dry Eye Syndrome.
  • 4. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
  • 5. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
  • 6. Women who are pregnant or lactating
  • 7. Patients on steroids, oral contraceptive pills, estrogen replacement therapy or any other medication that may adversely affect the outcome of the study
  • 8. Smokers/Alcoholics and/or drug abusers
  • 9. Patients with poorly controlled Hypertension ( >160/100 mm of Hg)
  • 10. Patients with evidence of malignancy
  • 11. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.)
  • 12. H/o hypersensitivity to the trial drug or any of its ingredients.
  • 13. Patients who have completed participation in any other clinical trial during the past six (06) months.
  • 14. Any other condition which the Principal Investigator thinks may jeopardize the study.

研究者

发起方
Central Council for Research in Ayurvedic Sciences CCRAS

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