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
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