Individualized homoeopathic medicines versus standard care in treatment of intestinal nematodes in children: A comparative cohort study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of patients with stool specimen positive for ova-parasites-cysts of intestinal nematodes
研究概览
简要总结
Intestinal parasitic infestation is a major public health problem in children of developing countries. Intestinal parasitic infections are considered amongst the most common infections throughout the world, and it is estimated that 3.5 billion subjects are suffering from it (WHO 1998). Currently, the need for active treatment is controversial. The large number of medicinal alternatives available lack proper evidence to define the best therapy. Though the use of homeopathic medicines is prevalent globally to treat the condition, rigorous research evidence in support of homeopathy in worm infestations has remained compromised. Under such circumstances, we intend to undertake this research project to compare homeopathic medicines with standard of care in the treatment of worm infestations in children and adolescents. A comparative cohort study will be carried out at D. N. De Homoeopathic Medical College and Hospital and Panchkari Radharani Adarsha Vidyalaya, 31B, Cristopher Road, Seal Lane, Topsia, Kolkata 700046 involving 100 children (50 n each cohort) with worm infestation and comparing individualized homeopathic medicines with standard care (anti-helminthic drugs). The primary outcome measure is the difference between groups in proportion of ova-parasites-cysts of intestinal nematodes in stool after 3 months of intervention. Secondary outcome measures will be PEDSQL score and reducing symptoms, assessed 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
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 3.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from intestinal nematodes (B
- •for 3 months or more 2) Age between 3 and 18 years 3) Patients of either sex, and transgender 4) Literate patients; ability to read English and/or Bengali or illiterate patient will be interviewed by the investigators maintaining adequate privacy to fill up the scale or questionnaires.
- •Providing written informed assent and/or consent voluntarily to participate in the trial.
- •The patient reporting to the OPD will be screened for the following symptom and the subject with minimum 5 of the following symptoms will be included in the study.
- •a) Pain around the umbilics.
- •b) Pruritus (itching or pain around anus) c) Hypopigmented patches in skin d) Pallor e) Nausea and vomiting f) Headache g) Gastric distension h) Loss of appetite i) Diarrhea j) History of passing intestinal nematodes in the stool.
排除标准
- •Systemic complications due to intestinal nematodes infestation 2) Acute gastro enteritis 3) Amoebiasis 4) Acute abdomen (appendicitis) 5) Vulnerable population – unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people 6) Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure 7) Patients having the history of tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence 8) Self-reported immune-compromised state 9) Already undergoing homeopathic treatment for chronic disease within last 1 month 10) Simultaneous participation in any other clinical trial.
结局指标
主要结局
Number of patients with stool specimen positive for ova-parasites-cysts of intestinal nematodes
时间窗: Baseline, after 1 month and 3 months
次要结局
- Pediatric Quality of Life (PEDSQL) score(Baseline, and every month, up to 3 months)
- Reducing symptoms - anal itching and discomfort, passing of gastrointestinal helminths in stool, abdominal pain, nausea, pallor, vomiting, diarrhea, anorexia, unusual irritability, weight loss, headache and pruritus skin(Baseline, and every month, up to 3 months)