跳至主要内容
临床试验/CTRI/2024/04/066271
CTRI/2024/04/066271尚未招募2 期

A Randomised Controlled Trial To Evaluate the efficacy of Scalp Acupuncture on Keratoconjunctivitis Sicca

Dr V Madhumitha1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年6月3日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
Assessment of tear production by Schirmer tear test

研究概览

简要总结

Keratoconjunctivitis sicca (KS), or dry eye syndrome is a disorder affecting the homeostasis of tear film, causing symptoms in eyes that may affect the quality of life in people. The prevalence of KS in India is approximated to be 5% to 35%. The study group will undergo scalp acupuncture needling at MS-13 bilaterally with stainless steel, sterile needles of length 1tsun and diameter of 28-30 gauge will be used for 12times, thrice a week for a month, while the control group would be waitlisted without any intervention until the study is completed. MS -13 points has been selected as this corresponds to the visual area in scalp acupuncture.  The primary outcome is The Schirmers tear test (SIT) is used to assess tear production. The Secondary outcome is Ocular Surface Disease Index (OSDI) for the assessment of symptoms related to dry eye disease and their effect on vision. The assessment will be checked on baseline, after 4weeks and 8 weeks.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Patients who are willing to give consent.

排除标准

  • Patients with defect of eyelid/eyelashes.
  • Past history of surgical eye operations in the last 3months.
  • Pregnancy, lactation or women planning pregnancy.
  • Eye ball or ocular appendage injuries.
  • Active ocular infections.
  • Diabetic retinopathy, cataract, or glaucoma.
  • Taking systemic corticosteroids or immunosuppressant treatment.
  • Needle phobia.
  • Any injuries on the scalp where needle would be inserted.
  • Others considered ineligible by investigator.

结局指标

主要结局

Assessment of tear production by Schirmer tear test

时间窗: baseline, 4weeks, 8weeks

次要结局

  • Assessment of Ocular Surface Disease Index(baseline, 4weeks, 8weeks)

研究者

发起方
Dr V Madhumitha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR V Madhumitha

TN Dr. M.G.R Medical University, Chennai

研究点 (1)

Loading locations...

相似试验