Efficacy of individualized homoeopathic medicines in reducing symptoms of allergic rhino-conjunctivitis in adults: 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
- 84
- 试验地点
- 1
- 主要终点
- Mini-Rhino-conjunctivitis Quality of Life Questionnaire (Mini-RQLQ)
研究概览
简要总结
Allergic Rhino-conjunctivitis (ARc) is induced by IgE mediated immune response after an allergen exposure characterized by presence of symptoms of inflammation of nasal mucosa causing nasal congestion, rhinorrhoea, nasal itching, watery and itchy eyes, sore eyes etc. This inflammation may also involved the mucous membrane of middle, pharynx, conjunctiva, sinuses. There are two varieties of ARc (a) Seasonal: symptoms around a particular season of the year when the pollen count is high to which the patient is sensitive are present in year and (b) Perennial: Symptoms present throughout the year. Most of the trial done by homoeopathic medicine prepared according to the Isopathic principle for treatment of ARc. Systematic Review of published trials showing high risk of bias in cochrane criteria. Some trials are going on but not yet published. All these show there is need to undertake a trial on ARc showing efficacy of individualized homoeopathic medicines in treatment of ARc.Thus this double blind randomized (2:1), placebo controlled trial using individualized homoeopathic medicine along with concomitant care will be conducted on 84 patients suffering from ARc in outpatient of D. N. De Homoeopathic Medical College and Hospital. Primary outcome measure will be Mini-RQLQ at baseline, every month and 3months of follow up. Secondary outcome measure will be (a) RAND MOS SF 36 1.O symptom score at baseline, every month and 3 months of follow up. (b) Serum IgE level and (c) Absolute Eosinophil count at baseline and end of 3 months of follow up. Group differences will be analyzed statistically. Results will be published in scientific journal.
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
- •1.Patient suffering from Allergic Rhino-conjunctivitis of mild to moderate intensity i.e. presenting the symptoms of Acute exacerbation of chronic Allergic-Rhino-conjunctivitis or Chronic Allergic Rhino-conjunctivitis (perennial and seasonal variety) [ICD 11 CA08.0Z] [ICD 11 9A60.02] 2.Age 18 to 65 years and of either sex or transgender.
- •3.History of recurrent attack of symptoms of Allergic Rhino-conjunctivitis since childhood 4.Atopic: reactive to inhaled allergens.
- •5.Elevated Absolute Eosinophil count and elevated Serum IgE level 6.Family history of atopy i.e. similar atopic conditions.
- •7.Participants having prior experience or knowledge of the treatment.
- •Example- primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet.
排除标准
- •1.Nasal abnormalities causing obstruction; e.g. nasal polyps deviated septum.
- •2.Away from usual environment for more than 1 week during trial.
- •3.Respiratory infections 4.Patients with risk of developing bronchial asthma 5.Abnormalities of eyes causing severe or gross impairment of visual acuity 6.Patients having cataract or any other gross structural abnormalities of eyes 7.Patient having obstruction of Naso-lachrymal duct 8.Other uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality of life.
- •9.Patients who are too sick for consultation 10.Pregnant and puerperal women, and lactating mothers 11.Substance abuse and/or dependence 12.Self-reported immune-compromised state 13.Oral or parenteral steroids in past 6 months 14.Conventional desensitization in past 6 months 15.Not having any previous history of allergic attack of symptoms of Allergic rhino-conjunctivitis.
- •16.Previous homoeopathic immunotherapy for Allergic rhinitis or Allergic conjunctivitis within last 6 months.
- •17.Undergoing homoeopathic treatment for any chronic disease within last 6 months.
- •18.Uncontrolled hypertension, diabetes, nephritic syndrome, renal insufficiency, uncontrolled hypothyroidism, severe or active liver diseases or any other uncontrolled systemic diseases affecting quality of life or organ failure.
- •19.Simultaneous participation in any other trial.
- •20.Vulnerable population- unconscious, non-ambulatory, too sick for consultation, differently abled, terminally and critically ill patient, mentally incompatible patients.
- •21.Patient not providing written informed consent voluntarily.
结局指标
主要结局
Mini-Rhino-conjunctivitis Quality of Life Questionnaire (Mini-RQLQ)
时间窗: Baseline, every month, up to 3 months
次要结局
- RAND Medical Outcome Study Short Form Health Survey 36-symptom score 1.0 (RAND MOS SF 36 1.0)(Baseline, every month, up to 3 months)
- Serum IgE(Baseline, 3 months)
- Absolute eosinophil count(Baseline, 3 months)
研究者
Bidisha Ray
D. N. De Homoeopathic Medical College and Hospital