Efficacy and Safety of an Ayurvedic Ophthalmic Ointment (Rasanjanadi Anjana) in the Treatment of Seasonal Allergic Conjunctivitis
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean change in responder rate as judged by subjects about the overall effect of treatment on symptoms using a five-point grading scale at the follow-up and end visit compared with baseline.
研究概览
简要总结
**Purpose:**To assess the effects of an Ayurvedic ophthalmic ointment (Rasanjanadi Anjana) in the treatment of Seasonal Allergic Conjunctivitis (SAC) compared to Loteprednol etabonate ophthalmic ointment 0.5%.
Design: Clinical, Prospective, Randomized, Open labelled, Parallel Group, Drug controlled, Single blind study.
Participants: (n=20) Patients of either gender aged 12 years or older and suffering from SAC, will be diagnosed on the basis of their history, the presence of moderate to severe ocular itching, and at least one of the following bilateral signs and symptoms of at least moderate severity: conjunctival hyperaemia, conjunctival chemosis, eyelid swelling, or tearing.
Methods: Patients will be randomized in a 1:1 ratio to study treatment with trial drug (Rasanjanadi Anjana) or Control drug (Loteprednol etabonate ophthalmic ointment 0.5%). Patients will be followed for 6 weeks at 5 scheduled visits (day 7, day 15, day 21, day 30, and day 45.). At each visit, ocular symptoms (itching, tearing) will be graded by the subject, and ocular signs (redness, eyelid swelling, chemosis) will be graded by the investigator, using ordinal grading scales. Subjects will be asked to assess the overall effect of treatment on symptoms using a five-point grading scale at the follow-up visits. In addition to individual scores, the composite scores for ocular signs and symptoms will be calculated.
Main outcome measures: Primary efficacy outcome will be mean change in responder rate as judged by subjects about the overall effect of treatment on symptoms using a five-point grading scale at the follow-up and end visit compared with baseline. Secondary efficacy outcome will be mean change in investigator assessment score (overall effect of treatment on signs and symptoms) at the follow-up and end visit compared with baseline. Also the mean change in the severity of individual and composite scores of ocular symptoms (itching, tearing) and signs (redness, eyelid swelling, chemosis, papillae) after 4 weeks of treatment compared with baseline. The tolerability and safety of Ayurvedic intervention (Rasanjanadi Anjana) will also be assessed.
Results: Both groups will be compared on the basis of main outcome measures.
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
- 12.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who will meet the following criteria will be selected for the study.
- •a) Patients of either gender aged 12 years or older and suffering from SAC, will be diagnosed on the basis of their history, the presence of moderate to severe ocular itching, and at least one of the following bilateral signs and symptoms of at least moderate severity: conjunctival hyperaemia, conjunctival chemosis, eyelid swelling, or tearing.
- •b) Patients able to maintain a diary.
- •c) Patients able and willing to provide written informed consent.
- •d) No expectation that subject will be moving out of the area of the study center during the study period.
排除标准
- •a) Patients with any other form of allergic conjunctivitis.
- •b) Patients with bacterial, chlamydial, viral, giant papillary, phlyctenular, purulent, and membranous conjunctivitis.
- •c) The presence of dry eye syndrome, blepharitis, uveitis, keratitis, and ocular trauma.
- •d) Patients with a history of ocular surgery performed in the last 3 months.
- •e) Patients who had systemic or ocular corticosteroids in the last 3 months, mast cell stabilizers within 2 weeks of randomization, or any other ophthalmic medication within 3 days of randomization.
- •f) Patients with retinal detachment, diabetic retinopathy, and progressive retinal disease.
- •g) Pregnant and lactating women.
- •h) Patients with a history of hypersensitivity to any of the study medications.
- •i) Active participation in any type of intervention study.
- •j) Patients who start developing complications.
结局指标
主要结局
Mean change in responder rate as judged by subjects about the overall effect of treatment on symptoms using a five-point grading scale at the follow-up and end visit compared with baseline.
时间窗: day 7, day 15, day 21, day 30, and day 45.
次要结局
- 1. Mean change in investigator assessment score (overall effect of treatment on signs & symptoms) at the follow-up & end visit compared with baseline.(2. Mean change in the severity of individual & composite scores of ocular symptoms (itching, tearing) & signs (redness, eyelid swelling, chemosis, papillae) after 4 weeks of treatment compared with baseline.)
研究者
Dr Palash Agrawal
Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India