Comparison of efficacy of Oral Melatonin with that of Oral Pilocarpine in the management of hyposalivation associated with Sjogrens syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
研究概览
简要总结
A randomized controlled study designed to compare the efficacy of oral melatonin with oral pilocarpine in the management of hyposalivation associated with Sjogrens syndrome. Patients in the age group of 20 to 60 years fulfilling inclusion and exclusion criteria are included in the study. Incisional lip biopsy will be done under local anesthesia and minor salivary glands are histopathologically examined. Sjogrens syndrome positive patients fulfilling the American European Consensus classification criteria are included. Patients in study group are given tablet melatonin 5mg once a day for two weeks and patients in control group are given tablet pilocarpine 5 mg thrice daily for 2 weeks. The unstimulated salivary flow rate, salivary PH, Schirmers lacrimal test are done at baseline,7thday,14th day for assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who satisfy the characteristic features of Sjogrens according to American European Consensus Sjogrens syndrome classification criteria Both Primary and Secondary Sjogrens syndrome Individuals within the age group of 20-60 years Both genders Willingness to participate in the study.
排除标准
- •Not willing to participate in study Clinically significant cardiopulmonary disease renal disease or gastrointestinal tract disease diabetes mellitus hypersensitivity to pilocarpine use clinically significant ocular disease Lactating or pregnant women Allergic patients, immunocompromised patients.
- •Past history of head and neck radiation treatment.
- •Acquired immunodeficiency syndrome (AIDS) Current use of anticholinergic drugs.
研究者
Dr GEETHANJALI D
Tamil Nadu Government Dental College and Hospital,Chennai