Role of Individualized Homoeopathic Medicines In Post-Streptococcal Sore Throat With Elevated Anti-Streptolysin O Antibody in Paediatric Age Group: A Single-Arm Pre-Post Interventional Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To detect the differences in serum anti streptolysin o antibody level in the paediatric age group
研究概览
简要总结
This study is intended to examine common pediatric conditions in clinical settings; despite this, there is a lack of evidence. Tonsillitis detected from bacterial origin confirmed by throat swab culture. The primary objective of this study is to evaluate the changes in ASO titre level at day 0 and month 2 and in month 3. The secondary objective of this study is to look after the sore throat pain model VAS level at day 0, and every month up to 3 months. Besides that, there is also look after the MONARCH at three months for look after the causal attribution of treatment. This is an open-lebel single-arm trial. Here intervention is used as individualized homoeopathic medicine according to the case symptoms similarity with concomitant care of lukewarm saline water gurgle. Dose and repetition guided by symptoms similarity and according to hommeopathic principals. The study contains only a sample size of 30 and the duration of therapy for three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Children suffering from sore throat of recent onset (more than 3 days), representing with clinical features of acute tonsillitis and bacterial aetiology confirmed by throat swab culture, and high ASO titre.
- •Participants of all sex.
- •Age between 5 and 15 years.
- •Literate patient’s parents; ability to read and write in Bengali and/or English and /or Hindi.
- •Illiterate participants will be interviewed by the investigators maintaining adequate privacy to fill up the scale or questionnaires.
- •The parents providing written informed consent voluntarily and the children providing with informed assent.
排除标准
- •Causes other than Bacterial.
- •Presence of uncontrolled co-morbidities.
- •Self-reported immune-compromised state.
- •Vulnerable population- Unconscious, non-ambulatory, too sick for consultation, terminally ill or critically ill patients, mentally incompetent people.
- •Simultaneous participation in any other clinical trials.
结局指标
主要结局
To detect the differences in serum anti streptolysin o antibody level in the paediatric age group
时间窗: Day 0, month 2 and month 3
with post-streptococcal sore throat after second and third months of treatment with
时间窗: Day 0, month 2 and month 3
individualised homoeopathic medicine.
时间窗: Day 0, month 2 and month 3
次要结局
- Modified Naranjo Criteria((MONARCH))
- Visual Analogue Scale [ VASs] of sore throat pain(model (STPM), namely pain VAS (STPIS), difficulty in swallowing VAS (DSS), and)
研究者
Gargi Mandal
National Institute of Homoeopathy