SCOPE OF BIOCHEMIC COMBINATION OF FIVE PHOS 6X VIS-À-VIS INDICATED HOMOEOPATHIC MEDICINE ON ANTHROPOMETRIC MEASUREMENTS AMONG THE UNDERWEIGHT CHILDREN UNDER 5 YEARS OF AGE GROUP (GRADE I AND GRADE II IAP CLASSIFICATION OF PROTEIN ENERGY MALNUTRITION): SINGLE-BLIND, RANDOMIZED CONTROL TRIAL
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate and compare the efficacy of the biochemic combination of five phos 6x versus indicated homoeopathic medicines on improving anthropometric measurements in underweight children with PEM under 5 years of age group (grade I and grade II IAP classification of PEM) in 12 months.
研究概览
简要总结
This study is a single blind randomized control trial designed with a primary objective to evaluate and compare the efficacy of a biochemic intervention against indicated homoeopathic medicine in improving the anthropometric measurements of children classified as grade one and grade two protein energy malnutrition as per Indian Academy of Pediatrics classification.
The need for this study stems from the significant global and national burden of undernutrition, particularly in India, where a high percentage of children under five are underweight. Malnutrition is a major public health challenge linked to increased susceptibility to infections, delayed cognitive development, and higher mortality rates. By exploring a homoeopathic approach, this study seeks to provide a potentially effective and safe alternative or complementary treatment to conventional methods.
The methodology involves recruiting children based on defined inclusion and exclusion criteria. The randomization sequence will be generated using a computer generated random number table to ensure unbiased allocation into two study groups. Allocation will be concealed from the investigator and participants at the point of enrollment using sequentially numbered opaque sealed envelopes, which will be opened only after the participant is officially enrolled. Participants will receive either biochemic combination of five phos six x or an indicated homoeopathic medicine. This is a single blind study where the participants remain unaware of their specific group assignment, while the investigator remains aware to facilitate the administration of individualized medicines.
The primary outcome will be measured through changes in anthropometric parameters including weight, height, mid upper arm circumference, and head circumference at monthly intervals for twelve months to evaluate improvement in nutritional status. The findings from this research are expected to contribute valuable data to the field of homoeopathy and offer a potential therapeutic option for addressing pediatric undernutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Children diagnosed with Grade one and Grade two malnutrition as per IAP guidelines.
- •2 Children within the age group of six months to five years.
- •3 Participants of both genders including boys and girls.
- •4 Children with recurrent respiratory illnesses such as rhinitis, laryngitis, tonsillitis, and pharyngitis, gastric complaints such as worm infection, constipation, and diarrhoea, skin complaints such as scabies and dermatitis.
- •5 Cases in which parents or legal guardians provide written informed consent and assent for their children.
排除标准
- •Children with a known case of any major illness like any congenital anomalies such as cleft lip, cleft palate, or congenital heart disease, tuberculosis or childhood cancer, cystic fibrosis or cerebral palsy.
结局指标
主要结局
To evaluate and compare the efficacy of the biochemic combination of five phos 6x versus indicated homoeopathic medicines on improving anthropometric measurements in underweight children with PEM under 5 years of age group (grade I and grade II IAP classification of PEM) in 12 months.
时间窗: Time Points: 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 weeks.
次要结局
- To know the commonly used homoeopathic medicines in the management of underweight children under five years of age(At the completion of twelve months of treatment)
- To know the commonly used posology in the management of underweight children under five years of age(At the completion of twelve months of treatment)
研究者
Dr Omkar Deepak Anavkar
Dr M L Dhawale Memorial Homoeopathic Institute