跳至主要内容
临床试验/CTRI/2019/09/021405
CTRI/2019/09/021405已完成不适用

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

Central Council for Research in Homoeopathy1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年1月11日最近更新:

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 hyper­sensitivity that begin after a clearly defined environmen­talexposure 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 objec­tive 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)

研究者

发起方
Central Council for Research in Homoeopathy
申办方类型
Research institution

研究点 (1)

Loading locations...

相似试验

已完成
3 期
Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy ToddlersMeningococcal MeningitisMumpsRubellaMeaslesVaricella
NCT00422292Sanofi Pasteur, a Sanofi Company1,664
已完成
4 期
The study to compare the immune response between intradermal and intramuscular injection of botulinum toxin AHealthy human volunteersEnzyme-Linked Immunosorbent Assay, Botulinum Toxins, Immunoglobulins, Antibodies
TCTR20211204002Dermatologic Surgery, Dermatology department, Siriraj hospital, Thailand100
进行中(未招募)
不适用
Randomized, double-blind study comparing the immunogenicity of two different brands of human insulin for the treatment of diabetesPatients suffering from diabetes mellitus type 1 or 2 with the indication for insulin treatment and dependent on insulin administration.MedDRA version: 9.1Level: PTClassification code 10012608Term: Diabetes mellitus insulin-dependentMedDRA version: 9.1Level: PTClassification code 10018209Term: Gestational diabetesMedDRA version: 9.1Level: PTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusMedDRA version: 9.1Level: PTClassification code 10051599Term: Diabetes mellitus managementMedDRA version: 9.1Level: PTClassification code 10012601Term: Diabetes mellitus
EUCTR2008-006763-36-BGMarvel Life Sciences Limited500
进行中(未招募)
不适用
ong Term Follow-up (LTFU) study 16-20 yrs after vaccine dose of hepatitis b with/without Hepatitis B immunoglobulin (HBIG) in newborns to Hepatitis B envelope antigen positive (HBeAg+) mothers.Vaccination of healthy newborns of HBsAg+ and/or HBeAg+ mothers against Hepatitis.
EUCTR2011-004879-36-Outside-EU/EEAGlaxoSmithKline Biologicals69
已完成
3 期
A Phase-III clinical trial to study the safety and immunogenicity of Bharat Biotech International Limited bivalent Oral Poliomyelitis Vaccine Type-1&3 vs. WHO pre-qualified trivalent polio vaccine in healthy neonates
CTRI/2010/091/000204Bharat Biotech International Limited288
Effectiveness of Homoeopathic Medicines Azadirachta... | 临床试验