Randomized comparative clinical trial to evaluate the efficacy of Saraswata Churna along with Kalyanaka Ghrita and Satvavajaya Chikitsa in children with Gaming Disorder.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reduction in the severity of gaming disorder score (IGDS9-SF) in children after two months of treatment with Saraswata Churna, Kalyanaka Ghrita, and Satvavajaya Chikitsa.
研究概览
简要总结
The rising prevalence of gaming disorder worldwide is alarming, with significant mental and physical health implications. Moreover, play has been shown to mitigate stress and build resilience in children, providing a safe space for them to explore, take risks, and express creativity. In light of these benefits, the shift from traditional play to digital interaction presents significant developmental challenges, underscoring the urgency of addressing gaming disorder through innovative and holistic approaches​
Given the increasing number of children falling prey to gaming addiction, there is a crucial need for exploring alternative treatments. Ayurveda, with its rich repository of formulations (Yogas) that act on the mind (Manas) and possess cognitive-enhancing (Medhya) properties, offers promising avenues for managing anxiety and depression associated with gaming disorder. Clinical trials using these Ayurvedic treatments could provide safer and more effective interventions, addressing the urgent need to support children affected by gaming disorder. Hence the study will be an effort to help children with gaming disorder through Ayurveda. This study is randomized comparative clinical trial comparing the efficacy of Saraswata Chura along with Kalyanaka Ghrita and Satvavajaya Chikitsa and only Satvavajaya Chikitsa in children with gaming disorder. IGDS-SF score and Dass 21 score will be used for comparing and reduction of severity of gaming disorder in children. Score will be assessed Before treatment, 30th day(inbetween treatment), 60th day (After treatment) and 90th day(Afterfollow up and completion of study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants in between age group of 12-16 years.
- •All participants will be included irrespective of Sex, religion and socioeconomic status.
- •Children addicted to indoor game including mobile game.
- •Children in whom parents are willing to sign the written consent form to participate.
排除标准
- •1.Particpants with the history of gambling.
- •2.Particpants with the history of MR, ADHD, Developmental and congenital disorders etc.
- •Participants with the history of addictions (alcohol, tobacco etc.) 4.
结局指标
主要结局
Reduction in the severity of gaming disorder score (IGDS9-SF) in children after two months of treatment with Saraswata Churna, Kalyanaka Ghrita, and Satvavajaya Chikitsa.
时间窗: IGDS9-SF less than 27.
次要结局
- Improvement in academic and personal life at the end of three months(3 months)
研究者
Dr Manpreeth Mali Patil
Poornima Ayurvedic Medical College, hospital and Research center, Raichur, Karnataka, India.