Evaluate the effect of punarnava arka in simple allergic conjunctivitis - a randomised controlled clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The results of reduction in signs and symptoms
研究概览
简要总结
Need for the study :
A type 1 hypersensitivity reaction to exogenous allergens in the atmosphere is simple allergic conjunctivitis. The estimated prevalence is 12.22%. Males are more likely to experience it (13.44%) than females (10.71%). The most frequent precipitating trigger was dust (35%) and the most common condition was persistent conjunctivitis (54.8%). There is no known unique aetiology for this moderate, non-specific inflammation of the conjunctiva, which presents with symptoms of increased lacrimation, itching, redness, and oedema. Since there is typically no cure for this illness, care is centred on symptom control and avoiding situations that exacerbate symptoms.
Punarnava is Shothahara and known for its anti-inflammatory action, Antimicrobial properties, Analgesic and Antioxidant activities so it may be brought in practice in the form of Arka. Punarnava arkais selected keeping in view to prove its efficacy in management of simple allergic conjunctivitis.
Aim :
Effect of PUNARNAVA ARKA in Simple Allergic Conjunctivitis
Objectives: To evaluate the effect of PUNARNAVA ARKA in Simple Allergic Conjunctivitis
To compare the effect of Punarnava Arka with control drug.
Research question :Is Effect of PUNARNAVA ARKA and Olopatadine Hydrochloride Ophthalmic Solution Ip 0.1% comparable in the management of simple allergic conjunctivitis?
Hypothesis: H0 – Effect of Punarnava Arka is not comparablein Simple Allergic Conjunctivitis
H1 – Effect of Punarnava Arka is comparable in Simple Allergic Conjunctivitis
Expected Outcome –The results of PUNARNAVA ARKA and Eyedrop Olopatadine Hydrochloride Ophthalmic Solution Ip 0.1% are comparable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting with signs and symptoms of Simple Allergic Conjunctivitis and fulfilling the diagnostic criteria.
排除标准
- •Patients suffering from other forms Allergic Conjunctivitis like Keratoconjunctivitis sicca Atopic keratoconjunctivitis Giant papillary conjunctivitis drug or material sensitivity etc Patients having severe conditions of ocular surface disorders Patients having complicated eye diseases like Trachoma Trichiasis Steven Johnson syndrome Synechiae etc will be excluded Patient suffering from bacterial viral chlamydial, parasitic and all other types of conjunctivitis (contagious & non contagious) Patients suffering from corneal ulcers opacities trauma foreign bodies OSD etc Conjunctival epitheliopathies like Pterygium Pseudo-pterygium Tumours Retention cysts Diagnosed cases of Glaucoma retinopathies optic neuritis dry eye and who are under long term topical ocular drug therapies for any ophthalmic infective conditions Extremely debilitated patients pregnant ladies those who are working with on screen professions Specific systemic disorders like Renal pathologies Uncontrolled Diabetes Hypertension and Hyperlipidaemia Cardiovascular diseases etc.
结局指标
主要结局
The results of reduction in signs and symptoms
时间窗: DAY 0th(Before Treatment) | DAY 21(After Treatment) | DAY 36(Follow Up)
of itching, redness, watering and oedema by Punarnava Arka and Eyedrop Olopatadine Hydrochloride ophthalmic soltion IP 0.1 percent are comparable.
时间窗: DAY 0th(Before Treatment) | DAY 21(After Treatment) | DAY 36(Follow Up)
次要结局
未报告次要终点
研究者
Dr Mahore Akash Manohar
KAHERs Shri BMK Ayurveda Mahavidyalaya, Shahapur, BELAGAVI, Karnataka, INDIA