| CTRI Number |
CTRI/2024/01/061903 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
22/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
‘‘A randomized controlled clinical trial to study the effect of ayurvedic regimen on manifestations of digital media overuse in children of age group 6-10 yrs. |
|
Scientific Title of Study
|
‘‘A randomized controlled clinical trial to study the effect of ayurvedic regimen on manifestations of digital media overuse in children of age group 6-10 yrs. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJyotsna Jayavant Ahir |
| Designation |
Associate professor |
| Affiliation |
Government Ayurvedic college Osmanabad |
| Address |
Government Ayurvedic college, Kaumarbhritya department,Balrog OPD no.37 Osmanabad shekapur Dist.-Osmanabad, state- Maharashtra
Osmanabad
MAHARASHTRA
413501
India |
| Phone |
7276538181 |
| Fax |
|
| Email |
drjyotsnaahir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnil Bhikachand Kale |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic college Osmanabad |
| Address |
Government Ayurvedic college, Kaumarbhritya department,Balrog OPD no.37 Osmanabad shekapur Dist.-Osmanabad, state- Maharashtra
Osmanabad
MAHARASHTRA
413501
India |
| Phone |
9284508076 |
| Fax |
|
| Email |
kaleanilb@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrJyotsna Jayavant Ahir |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic college Osmanabad |
| Address |
Government Ayurvedic college, Kaumarbhritya department,Balrog OPD no.37 Osmanabad shekapur Dist.-Osmanabad, state- Maharashtra
Osmanabad
MAHARASHTRA
413501
India |
| Phone |
7276538181 |
| Fax |
|
| Email |
drjyotsnaahir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic college, Kaumarbhritya department,Balrog OPD no.37 Osmanabad shekapur Dist.-Osmanabad, state- Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr.Jyotsna Jayavant Ahir |
| Address |
Government Ayurvedic college Osmanabad Shekapur Dist.Osmanabad,State-Maharashtra 413501 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrJyotsna Jayavant Ahir |
Government Ayurvedic College Osmanabad |
Government Ayurvedic College Osmanabad department-Kaumarbhritya,Balrog OPD no.37
Osmanabad
MAHARASHTRA |
7276538181
drjyotsnaahir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Govt. Ayurvedic college Osmanabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R418||Other symptoms and signs involvingcognitive functions and awareness. Ayurveda Condition: Asatmendriyarthasayogga , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: 1.Avoid overuse of Digital Media.
2.Involve yourself in child’s daily activity and spend time with them.
3.Do daily Yoga activity.
4.Promote your child for outdoor games with friends and sibling, Ritucarya: -, Acara Rasayana:1.Avoid overuse of Digital Media, Other:-, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Medhabayladi Yoga orally + Bala taila Shiroabhyanga ,Padabhyanga + Counseling , Reference: Charak Samhita (Cha.Chi.1-3/30,31) (Cha.Su4/7).andKashyapa Samhita Dhatri-chikitsita-dhyaya respectively, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Bala taila for topical use as per required does |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1 Children between age group of 6 to 10 years irrespective of sex religion and socioeconomic status
2 All Children using Digital Media more than 2 hours/day 17 presenting with following clinical features of Digital Media Overuse will be included in this study
headache dryness of eyes burning sensation of eyes sleep disturbance irritability poor concentration and attention span etc The children who will have at least 4 clinical features of Digital Media Overuse will be included in this study in either group
|
|
| ExclusionCriteria |
| Details |
Children with anemia
Children with psychological disorders like ADHD, Autism etc
Children with K/C/O any Neurological disorder.
Children suffering from any systemic or metabolic disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nil or % wise decrease in sign and symptoms developed due to digital media overuse |
at the end of 15th days, 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To report adverse effect if any observed during study period.
2.To assess the recurrence of the diseases |
1. 15 days.
2. 2 Months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
10/02/2024 |
| 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
|
I am Jyotsna Jayavant Ahir Ph.D scholar Balrog , at Government Ayurved collage, Osmanabad, trying to evaluate effect of ayurvedic medicine on manifestations of digital media overuse in children of age group 6-10 yrs.During this trail trying to evaluate the untoward effect of Medhabalyadi and Bala Taila in digital media overuse. As there is no previous work done on this topic, so emphasis will be made to find out easy cost effective method to control manifestations of digital media overuse. Also I will trying to find out the new ways to control the bad habit of digital media overuse in children.To assess the recurrence of the diseases after 1 month of completion of treatment. |