| CTRI Number |
CTRI/2025/02/080404 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Oral medication and counselling in Gaming Disorder. |
|
Scientific Title of Study
|
Randomized comparative clinical trial to evaluate the efficacy of Saraswata Churna along with Kalyanaka Ghrita and Satvavajaya Chikitsa in children with Gaming Disorder. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manpreeth Mali Patil |
| Designation |
Assistant Professor |
| Affiliation |
Poornima Ayurvedic Medical College, hospital and Research center, Raichur, Karnataka, India. |
| Address |
Poornima Ayurvedic Medical College, hospital and Research center, Raichur, Karnataka, India.
Raichur
KARNATAKA
584103
India |
| Phone |
8310095358 |
| Fax |
|
| Email |
manpreethmalipatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manpreeth Mali Patil |
| Designation |
Assistant Professor |
| Affiliation |
Poornima Ayurvedic Medical College, hospital and Research center, Raichur, Karnataka, India. |
| Address |
Poornima Ayurvedic Medical College, hospital and Research center, Raichur, Karnataka, India.
Raichur
KARNATAKA
584103
India |
| Phone |
8310095358 |
| Fax |
|
| Email |
manpreethmalipatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Durgaprasad Dash |
| Designation |
Professor & Head, Dept of Kaumarabhritya |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University, Cuttack, Odisha |
| Address |
Sri Sri College of Ayurvedic Science and Research Hospital,
Sri Sri University, Cuttack, Odisha
Cuttack
ORISSA
754006
India |
| Phone |
9853435916 |
| Fax |
|
| Email |
durga.d@srisriuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital,
Sri Sri University, Cuttack, Odisha |
|
|
Primary Sponsor
|
| Name |
Dr Manpreeth Mali Patil |
| Address |
Poornima Ayurvedic Medical college, hospital and Research centre, Mantralaya Road, Raichur, Karnataka, India Pincode- 584103 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manpreeth Mali Patil |
Poornima Ayurvedic Medical college, hospital and Research centre, Raichur |
Room no 6, Department of Kaumarabhritya, Poornima Ayurvedic Medical college, hospital and Research centre, Mantralaya Road, Raichur Karnataka, India.Pincode- 584103
Raichur
KARNATAKA |
9620457667
manpreethmalipatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical research of Faculty of Health & Wellness,Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University Cuttack |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Y93C||Activities involving computer technology and electronic devices. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saraswata Churna, Reference: Bhaishajya Ratnavali, Unmada Adhikara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Kalyanaka Ghrita and Honey), Additional Information: Satvavajaya Chikitsa for two months in 8 sessions | | 2 | Comparator Arm | Procedure | - | Satvavajaya Chikitsa | (Procedure Reference: Charaka Sutra Stana, Procedure details: Satvavajaya Chikitsa (Behavioral intervention program) for two months divided in 8 sessions).)
|
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants in between age group of 12-16 years.
2. All participants will be included irrespective of Sex, religion and socioeconomic status.
3. Children addicted to indoor game including mobile game.
4. Children in whom parents are willing to sign the written consent form to participate. |
|
| ExclusionCriteria |
| Details |
1.Particpants with the history of gambling.
2.Particpants with the history of MR, ADHD, Developmental and congenital disorders etc.
3. Participants with the history of addictions (alcohol, tobacco etc.)
4. Participants with the H/O systemic illness. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
IGDS9-SF less than 27. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in academic and personal life at the end of three months |
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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). |