Efficacy of individualized homoeopathic medicines in the treatment of functional dyspepsia in adults: A double-blind, randomized, placebo-controlled trial using different homoeopathic repertories
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire (PAGI-SYM)
研究概览
简要总结
Functional dyspepsia is characterized by persistent upper gastrointestinal symptoms, such as burning pain, early satiety, postprandial fullness, and belching, lasting over three months without an identifiable organic cause. It affects about 20–30% of people globally, with prevalence rates in India ranging from 7.6% to 49%. despite the fact that homoeopathic medications are widely used throughout the world to treat the illness, there is a dearth of solid evidence to support the use of individualized homoeopathic medicines in the treatment of functional dyspepsia. Thus, this 3-months,double-blind, randomized, placebo-controlled trial is aimed at evaluating the efficacy of homoeopathic medicines in the treatment of functional dyspepsia using different homoeopathic repertories. The primary outcome measure is PAGI-SYM questionnaire, the secondary outcome measures are SF-NDI and MYMOP-2 questionnaire, all will be measured at baseline, and every month, up to 3 months. Comparative analysis will be carried out to detect group differences. 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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18-60 years
- •Participants of either sex or transgender
- •Diagnosed functional dyspepsia (ICD 11- DD90.3) as per ROME IV criteria.
- •One or more of the following for the last 3 months with symptom onset at least 6 months prior to diagnosis: a) Bothersome postprandial fullness.
- •b) Bothersome epigastric pain c) Bothersome early satiation d) Bothersome epigastric burning And, no evidence of structural disease (at upper GI endoscopy) that is likely to explain the symptoms.
- •Patients who are already undergoing regular therapy for dyspeptic ailments, provided the medications are stopped completely at least 2 weeks prior study entry.
- •Providing written informed consent
- •Patients with ability to understand English/Bengali/Hindi.
排除标准
- •Alarm symptoms of dyspepsia a)Unintentional weight loss b)Difficulty swallowing(dysphagia) c)Painful swallowing(odynophagia) d)Unexplained iron deficiency anemia e)Persisting vomiting f)Detectable mass or Lymphadenopathy g)Family history of upper gastrointestinal cancer
- •Recent significant GI surgery within last 6 months.
- •Patients who are too sick for consultation.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life.
- •Pregnancy, puerperium and lactation.
- •Substance abuse and/or dependence (TAPS TOOL)
- •Undergoing homeopathic treatment for any chronic disease within last 3 months.
- •Unwilling to take part and not giving consent to join the study.
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire (PAGI-SYM)
时间窗: Baseline, and every month, up to 3 months
次要结局
- Short Form Nepean dyspepsia index (SF-NDI)(Baseline, and every month, up to 3 months)
- Measure Yourself Medical Outcome Profile v.2 (MYMOP-2)(Baseline, and every month, up to 3 months)
研究者
Leishangthem Rajeshwori Devi
D. N. De Homoeopathic Medical College and Hospital