Single Blind Randomized Comparative Study in the Modulation of Serum Immunoglobulin-E levels of Atopic patients treated with Azadirachta indica-Q and Echinacea angustifolia-Q
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction in Serum Ig-E Levels
研究概览
简要总结
The classic Definition of Immunityis protection from Infectious pathogen & the normal immune response.An important undesirable side effect of immunity is the development,under some conditions, of allergy or other types of Immune Hypersensitivity.
Hypersensitivity is defined as an exaggerated orinappropriate state of normal immune response with onset of adverse effects onthe body.For the induction of Hypersensitive reactions, the hostshould have had contact with the antigen (allergen). During first contact ofhost with antigen, sensitisation takes place. Subsequent contact with allergencauses manifestation of Type-1 Hypersensitivity.
Antibodies (Cytotropic IgE) are fixed on surface oftissue cells in sensitized individuals. These combines with cell fixedantibody, leading to release of pharmacologically active substances whichproduce the clinical reaction.
‘Atopy’ is defined as a personal and/or familial tendency,to become sensitized and produce IgE antibodies in response to ordinaryexposure to allergens, usually proteins. Therefore Atopy is an IgE antibodyhigh-responder who may or may not have clinical symptoms.Symptomsof Type-I hyperÂsensitivity that begin after a clearly defined environmenÂtalexposure should prompt to eliminate future exposure to the suspected allergen.
The heart of the allergic response lies in thequantity and specificity of IgE production of patients to allergens. Thehistory, aided by a physical examination and objecÂtive tests of IgEsensitivity (either skin tests or serum IgE measurements), is often used todiagnose Allergic / Atopic conditions.
Azadirachta indica (Neem) andEchinacea angustifolia (Narrow-leaf coneflower) are found tobe effective as immune modulators both in Animal and Human Studies conductedearlier. They are also found to be effective in treating Atopic patients inHomoeopathy too.
These details intended me to do the comparativestudy of the effectiveness of the two said medicines in controlling serum Ig-Elevels of atopic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant 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
- •Patients with elevated Serum Immunoglobulin-E (IgE) level with or without any Clinical Manifestation.
- •Elevated IgE level > 158 IU/mL or as per the reference range in other Units / for other laboratory methods.
- •Patients associated with Atopic Symptoms.
排除标准
- •Patients with Systemic Complications
- •Patients with Autoimmune diseases.
- •Those who are already under chronic medication for elevated IgE levels.
结局指标
主要结局
Reduction in Serum Ig-E Levels
时间窗: 90 Days
次要结局
- Symptomatic Relief(90 days)
