Efficacy of individualized homoeopathic medicines in improving symptoms of dry eye disease in adults: A double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Ocular Surface Disease Index (OSDI) scores
研究概览
简要总结
One of the most common eye diseases, dry eye disease (DED), affects millions of individuals worldwide. 5% to 50% of people worldwide have it, depending on the region they inhabit. Dry eye is a disorder of the tear film due to tear deficiency or excessive tear evaporation which causes damage to the interpalpebral ocular surface and is associated with symptoms of ocular discomfort. It is evident that there are numerous homoeopathic books that list symptoms of dry eye disease under various drugs, however, no conclusive evidence of efficacy of IHMs in DED is available until now. This research aims to alleviate the symptoms of dry eye disease by assessing OSDI scores, decrease the impact of contributing factors (mobile & laptop use etc.), improving the patient’s physical and emotional well-being, minimizing the adverse effects of artificial tear drops and determining if IHMs are more effective than placebo in treating DED. A double-blind, randomized, placebo-controlled trial will be conducted on 50 adults suffering from DED at the outpatients of D. N. De Homoeopathic Medical College and Hospital. Primary outcome measure is to achieve OSDI score 13-32. Secondary outcome measures are SIT, MYMOP2 scoring. All outcomes will be measured every month up to 3 months. Group differences will be analyzed statistically. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals with an ocular surface disease index score (OSDI) 13 to 32(mild to moderate) and a Schirmer-1 test wetness of less than 15 millimeters.
- •Individuals who are 18 to 65 years old.
- •Patients of either gender or transgender.
- •Participants having prior experience or knowledge of the treatment; e.g., primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet.
排除标准
- •Individuals with OSDI score more than 32 (severe).
- •Those who have had eye surgery or trauma during the last three months.
- •Individuals who decline to provide written informed consent.
- •Patients suffering from various ocular disorders, such as glaucoma or keratitis.
- •A patient whose systemic disorders are the cause of their DED.
- •Women who are breastfeeding or pregnant or in puerperium.
- •Those suffering from any type of autoimmune condition, such as Sjogren syndrome, SLE, etc.
- •Persons with simultaneous participation in any other clinical trial.
- •Vulnerable population- Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
- •Tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
- •Self-reported immune-compromised state AIDS, Hepatitis, etc.
- •A person with uncontrolled diabetes or any other uncontrolled systemic disorders.
- •A patient receiving continuous homoeopathic treatment for any other chronic illness.
结局指标
主要结局
Ocular Surface Disease Index (OSDI) scores
时间窗: Baseline, every month, up to 3 months
次要结局
- Measure Yourself Medical Outcome Profile (MYMOP-2) questionnaire(Baseline, every month, up to 3 months)
- Schirmer-1 test scores (without anaesthesia)(Baseline, every month, up to 3 months)
研究者
Dr Abhishek Karmakar
D. N. De Homoeopathic Medical College and Hospital