A prospective interventional study on the effect of individualized homoeopathic treatment on sleep quality and glycemic control in type 2 diabetes mellitus patients with insomnia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This is a single-arm, prospective, interventional, non-randomized clinical study conducted over 18 months. Participants will be adults aged 30–65 years diagnosed with Type 2 Diabetes Mellitus as per ADA 2024 criteria, who also suffer from insomnia based on DSM 5 or ICSD 3 criteria for at least 3 months. Eligible participants will have HbA1c levels between 6.5 percent and 7.5 percent and a Pittsburgh Sleep Quality Index PSQI score greater than 5. They must be able to give informed consent, understand the study language, and comply with study procedures. Participants will be excluded if they have Type 1 or secondary diabetes, are on insulin or other alternative therapies (except homeopathy), use sleep medications or antidepressants, work irregular shifts, have serious medical or psychiatric conditions, pregnancy/lactation, or substance abuse. All eligible patients will receive individualized homeopathic medicines selected based on their characteristic symptoms and totality. Both centesimal and fifty millesimal potencies GMP-certified will be used, along with dietary advice for all participants.
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
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of Type 2 Diabetes Mellitus according to American diabetes association 2024 criteria Patients of type 2 diabetes mellitus meeting DSM 5 or ICSD 3 criteria for insomnia for at least 3 months Patients with HbA1c levels ranging from 6.5 to 7.5 percentage Patients of age 30 to 65 years of age irrespective of their gender race religion and socio- economic status Pittsburgh sleep quality index score more than 5 Patient capable of giving informed consent willingness and ability to comply with scheduled visits treatment plans and other study procedures Patients who are able to understand and communicate in the language used for data collection and consultations.
排除标准
- •Patients with type 1 Diabetes Mellitus or other forms of secondary diabetes Patients currently on insulin therapy or using any form of complementary or alternative medicine other than homeopathy for the management of diabetes or sleep disorders Shift workers or individuals with irregular sleep patterns due to lifestyle or occupational reasons.
- •Patients who use sleep medications or antidepressants Patients with unstable psychiatric illness uncontrolled or life-threatening medical conditions or clinically diagnosed complications related to type 2 diabetes mellitus that may affect quality of life Pregnant or lactating women Patients on substance abuse.
研究者
Inturi Lakshmi Durga
National Institute of Homoeopathy