Efficacy of the homoeopathic medicine Morgan pure in LM potencies in asthma control in adolescents and adults: A series of n-of-1 trials
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Asthma Control Test(ACT) score
研究概览
简要总结
Asthma is a significant non-communicable disease globally with major public health consequences for both children and adults with high morbidity, and mortality in severe cases. Asthma is a prevalent major non-communicable disease that significantly affects the quality of life for many. The worldwide prevalence of asthma is estimated to be around 300 million people, and it is projected that an additional 100 million may be impacted by the condition by the year 2025. The national burden of asthma is estimated by the Indian Study on Epidemiology of Asthma, Respiratory Symptoms, and Chronic Bronchitis in Adults (INSEARCH) to be 17.23 million, with an overall prevalence of 2.05%. Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation. it is defined by the history of respiratory symptoms, such as wheezing, shortness of breath, chest tightness, and cough, that vary over time and intensity, together with variable expiratory airflow limitation. This study attempts to identify the efficacy of homoeopathic medicine Morgan pure in asthma control in adolescents and adults after 102 days of intervention. This study is aimed to detect the difference between the groups Morgan pure and placebo group in the ACT (Asthma Control Test) questionnaire, spirometry measures – Forced Expiratory volume in one second (FEV1), FVC (Forced vital capacity), FEV1/FVC, PEF (Peak Expiratory Flow), AQLQ(S)-(Asthma Quality of Life Questionnaire for 12 years and older), and MYMOP-2(Measure Yourself Medical Outcome Profile) questionnaire in treatment of asthma over 102 days of intervention. A series of double-blind, randomized, placebo-controlled n-of-1 trials will be conducted on 21 adults who are suffering from asthma at the outpatient department of D. N. De Homoeopathic Medical College and Hospital. Group differences will be calculated in intention-to-treat and per-protocol approaches. Results will be published in scientific journals.
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
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 12-21 years(adolescent) and 21-65 years.
- •Patients of either sex or transgender iii.
- •Patients with asthma (ICD -11 code CA23) are confirmed by the following criteria- HISTORY OF TYPICAL VARIABLE RESPIRATORY SYMPTOMS: Wheeze, shortness of breath, chest tightness and cough (Descriptors may vary between cultures and by age).
- •Symptoms or features that support the diagnosis of asthma- ✓ More than one type of respiratory symptom (in adults, isolated cough is seldom due to asthma) ✓ Symptoms occur variably over time and vary in intensity ✓ Symptoms are often worse at night or on waking ✓ Symptoms are often triggered by exercise, laughter, allergens, cold air ✓ Symptoms often appear or worsen with viral infections CONFIRMED VARIABLE EXPIRATORY AIRFLOW LIMITATION: Documented excessive variability in lung function (one or more of the following): The greater the variations, or the more occasions excess variation is seen, the more confident the diagnosis.
- •If initially negative, tests can be repeated during symptoms or in the early morning.
- •Positive bronchodilator (BD) responsiveness (reversibility): Adults: increase in FEV1 of greater than 12% and 200 ml.
- •(greater confidence if the increase is greater than 15% and greater than 400 mL).
- •Measure change 10-15 minutes after 200-400 mcg salbutamol (albuterol) or equivalent.
- •âœ“ Excessive variability in twice-daily PEF over 2 weeks: Adults average daily diurnal PEF variability greater than 10%.
- •Documented expiratory airflow limitation: At a time FEV1 is reduced (e.g. during testing above), confirmed that FEV1/FVC is also reduced compared with the lower limit of normal (it is usually greater than 0.75-0.80 in adults).
- •Indication of Morgan pure- ✓ History of pneumonia or bronchopneumonia; never well since.
- •Bronchitis and asthma(self-reported) ✓ At least 3 important symptoms from the symptomatology of Morgan pure.
- •âœ“ Differentiation and comparison with other drugs with the help of the literature.
- •âœ“ Individualization of the case to be ratified by consensus among three prescribers.
排除标准
- •Known lower respiratory tract disease other than asthma.
- •Not providing written informed consent and/or assent voluntarily to participate in the study.
- •ICD-11 code- allergic asthma with status asthmaticus (CA23.01), non-allergic asthma, with status asthmaticus (CA23.11), aspirin-induced asthma (CA23.20), unspecified asthma with status asthmaticus (CA23.31).
- •Severe persistent asthma (FEV1 less than 60%) v.
- •Need for immediate ICU care vi.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting the quality of life or any organ failure.
- •Tobacco chewing and/or smoking, alcoholism and/or any other form(s)of substance abuse and/or dependence.
- •Self-reported immune-compromised state.
- •Already undergoing homoeopathic treatment for chronic diseases other than asthma within the last 1month.
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
Asthma Control Test(ACT) score
时间窗: Baseline, every 17 days, up to 102 days
次要结局
- Spirometry measures: FEV1 (Forced Expiratory Volume in 1 second), FVC (Forced vital capacity), FEV1/FVC and PEF (Peak Expiratory Flow)(Baseline, every 17 days, up to 102 days)
- AQLQ(S)-(Asthma Quality of Life Questionnaire for 12 years and older)(Baseline, every 17 days, up to 102 days)
- Measure Yourself Medical Outcome Profile, version 2.0 (MYMOP-2)(Baseline, every 17 days, up to 102 days)
研究者
Sourav Bera
D. N. De Homoeopathic Medical College and Hospital