Effect Of Individualised Homoeopathic Medicines In Cases Of Prediabetes With Unavoidable Accessory Circumstances In Adult Population - A Prospective Single Arm Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- To evaluate changes in glycemic levels (FBS, OGTT, HbA1c) before and after homoeopathic intervention and document and analyse the types of unavoidable accessory circumstances considered during remedy individualisation
研究概览
简要总结
This study aims to assess the effect of individualised homoeopathic medicines selected with consideration of unavoidable accessory circumstances on glycemic levels and its impact on daily living in prediabetic individuals. It is a single arm study of 16 months duration in which 65 participants will be enrolled and their level of FBS, OGTT, HbA1c and the symptom burden using diabetes symptom checklist - revised will be recorded before and after homoeopathic intervention. The patient’s perception of homeopathic treatment using ORIDL scale will also be recorded. Analysis of data will be done using repeated measure ANOVA at the end of 6 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
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with FBS between 100-125 mg/dl and/or OGTT between 140-199 mg/dl and/or HbA1c between 5.7%-6.4% Participants with presence of one or more unavoidable accessory circumstances like chronic stress, poor sleep hygeine, emotional conflicts, occupational stress, family related strain etc.
- •Participants with no serious complications based on clinical evaluation Participants who give their valid consent to participate in the study.
排除标准
- •Participants who have diagnosed Type2 Diabetes Mellitus or any other systemic illness Participants who are on other medications for some other medical conditions or on antidiabetic medication of some other system Pregnant or lactating women Participants with a known psychiatric illness Participation in any other clinical trial during the study.
结局指标
主要结局
To evaluate changes in glycemic levels (FBS, OGTT, HbA1c) before and after homoeopathic intervention and document and analyse the types of unavoidable accessory circumstances considered during remedy individualisation
时间窗: The study duration will be 16 months | enrolment- 6 months | follow up- 6 months | data analysis- 2 months | report writing- 2 months | For statistical analysis | FBS and OGTT will be recorded at baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks | and HbA1c- at baseline, 12weeks and 24 weeks
次要结局
- To evaluate changes in the symptom burden using Diabetes Symptom Checklist- Revised(baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks)
研究者
Salika Shahid
Bakson Homoeopathic Medical College and Hospital