Walnut Shell Glasses Moxibustion for Dry Eye Syndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- change from baseline in OSDI score
研究概览
简要总结
This trial is designed to evaluate the efficacy of walnut shell glasses moxibustion for dry eye syndrome compared with sodium hyaluronate eye drops.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
outcome assessor and statistician will be blinded
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eyes are in line with dry eye diagnostic criteria.
- •Age 18 to 75 years,
- •signed informed consent, voluntary adherence to treatment for more than 1 month.
排除标准
- •combined with other eye disease (such as conjunctiva, cornea and iris have significant lesions).
- •eye surgery within 3 months.
- •pregnant or lactating women.
- •oral the drugs which could inhibit lacrimal gland secretion.
- •severe meibomian gland dysfunction.
- •severe eye burns, chemical injury patients.
- •combined with cardiovascular and cerebrovascular, liver, kidney and hematopoietic system and other serious primary disease, mental patients.
- •patients with Sjogren's syndrome.
- •patients who are participating in other drug clinical trials.
- •patients who are using other drugs or therapies for the treatment of dry eyes.
研究组 & 干预措施
Walnut Shell Glasses Moxibustion
Use wire to make a glass frame which can fix two walnut shells and moxa roll in front of the eyes, the walnut shell should be soaked in medlar chrysanthemum water and use the moxibustion to treat eye disease.
干预措施: Walnut Shell Glasses Moxibustion (Procedure)
Sodium hyaluronate eye drops
Commonly used artificial tears in clinical.
干预措施: Sodium hyaluronate eye drops (Drug)
结局指标
主要结局
change from baseline in OSDI score
时间窗: week 4, week 16, week 28
We use the ocular surface disease index(OSDI) to evaluate the degree of dry eye. Assessing time point: at week 4, week 16, week 28.
次要结局
- the efficacy of Walnut Shell Glasses Moxibustion(week 4, week 16, week 28)
- change from baseline in SchimerⅠtext(week 2, week 4)
- change from baseline in VAS of eye discomfort(week 4, week 16, week 28)
- change from baseline in BUT(week 2, week 4)
- change from baseline in mean daily VAS score(week 1-4, week 16, week 28)
- change from baseline in corneal fluorescence staining scores(week 2, week 4)
- change from baseline in mean weekly OSDI score(week 1-4, week 16, week 28)
- patiant's expectations for moxibustion(baseline)
研究者
Weiwei Fu
Postgraduate
Guang'anmen Hospital of China Academy of Chinese Medical Sciences