Randomized comparative clinical trial to evaluate the efficacy of Saraswata Churna along with Kalyanaka Ghrita and Satvavajaya Chikitsa in children with Gaming Disorder.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 12.00 Year(s) to 16.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: IGDS9-SF less than 27.
Secondary Outcomes
- Improvement in academic and personal life at the end of three months(3 months)
Investigators
Dr Manpreeth Mali Patil
Poornima Ayurvedic Medical College, hospital and Research center, Raichur, Karnataka, India.