Comparative study on Effects of TCM Acupuncture Without and With RAGA Therapy on Young Adults with Sleep Difficulties: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The study aims to assess the improvement in sleep quality following combined TCM acupuncture and RAGA therapy and to compare the effectiveness of each therapy in enhancing sleep outcomes.
研究概览
简要总结
This randomized controlled trial aims to evaluate the effects of Traditional Chinese Medicine (TCM) acupuncture with and without RAGA therapy on sleep quality in young adults with self-reported sleep difficulties. Participants aged 18–30 years experiencing disturbed sleep for at least three months will be randomly assigned to two groups: one receiving TCM acupuncture alone and the other receiving combined TCM acupuncture and RAGA therapy. The study will assess changes in sleep parameters, sleep quality, and quality of life before and after intervention using standardized assessment tools. The findings are expected to determine whether the combination of acupuncture and RAGA therapy provides superior improvement in sleep outcomes compared to acupuncture alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •The study includes consenting males and females aged 18–30 years with sleep disturbances for at least three months, including difficulty falling or staying asleep, early awakening, poor sleep quality, daytime sleepiness, delayed sleep onset, or frequent nightmares.
排除标准
- •The study excludes individuals below 18 or above 30 years, those without informed consent, and participants with neurological or major psychiatric disorders.
- •Subjects with serious medical illnesses, those on sleep-altering medications, current substance abusers, night or rotating shift workers, and pregnant females are also excluded.
结局指标
主要结局
The study aims to assess the improvement in sleep quality following combined TCM acupuncture and RAGA therapy and to compare the effectiveness of each therapy in enhancing sleep outcomes.
时间窗: 18 months
次要结局
- The study aims to evaluate baseline sleep quality in young adults with sleep difficulties, compare pre- and post-intervention sleep parameters within each group, and assess changes in quality of life after the intervention.(18 months)
研究者
DRPAHUNI GARG
Sant Hirdaram Medical College of Naturopathy & Yogic Sciences for Women Bhopal MP