| CTRI Number |
CTRI/2022/05/042864 [Registered on: 27/05/2022] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Counselling] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of Smrutisudha Granules to Enhance Memory in Adolescents Having Social Medica Addiction |
|
Scientific Title of Study
|
A Randomized Control Clinical Study to Evaluate the Effect of Smrutisudha Granules to Enhance Memory in Social Media Addicted Adolescents |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreelakshmi C L |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD NO.103, Department of Kaumarbhritya, Parul Ayurved Hospital, Parul University at Limda, Tal. Waghodia, Vadodara, Gujarat Vadodara GUJARAT 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
7025375357 |
| Fax |
02668-260201 |
| Email |
sreelakshmicl92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Kumar Pani |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD NO.103, Department of Kaumarbhritya, Parul Ayurved Hospital, Parul University at Limda, Tal. Waghodia, Vadodara, Gujarat Vadodara GUJARAT 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9408707703 |
| Fax |
02668-260201 |
| Email |
drsudhirpani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhir Kumar Pani |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD NO.103, Department of Kaumarbhritya, Parul Ayurved Hospital, Parul University at Limda, Tal. Waghodia, Vadodara, Gujarat Vadodara GUJARAT 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9408707703 |
| Fax |
02668-260201 |
| Email |
drsudhirpani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Ayurveda, Parul University at Limda, Tal. Waghodia, Vadodara, Gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Department of Kaumarbhritya |
| Address |
Parul Institute Of Ayurveda, Parul University at Limda, Tal. Waghodia, Vadodara, Gujarat 391760 |
| Type of Sponsor |
Private medical college |
|
|
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 Sreelakshmi C L |
Parul Ayurved Hospital |
OPD NO. 103 Department Of Kaumarbhritya, Parul Ayurved Hospital, Parul University at Limda, Tal. Waghodia, Vadodara, Gujarat 391760 Vadodara GUJARAT
Vadodara
GUJARAT |
7025375357
02668-260201
sreelakshmicl92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z659||Problem related to unspecified psychosocial circumstances. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Smrutisudha Granules, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 7.5(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Counselling | Counselling will be provided to the enrolled patient through a certified phsychiatric counsellor or Ayurvedic physician having M.D in Manasaroga |
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Children who are found to have Social Media Addiction after screening. |
|
| ExclusionCriteria |
| Details |
1.K/C/O Mental retardation, chronic illness like TB, DM etc., congenital disorder like down syndrome and genetic disorders.
2.K/C/O Any major systematic disorder which alter or limit community development of child.
3.Behavior disorder like attention deficit hyperactivity disorder (ADHD), autism etc.
4.Any other addictions other than social media such as drug or alcohol.
5.Blind or deaf. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Screening :- Social Media Addiction Scale Student form (SMAS-SF)
Primary Outcome: PGI Memory Scale |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary Outcome :- Smruthi and Medha pariksha ( Manasa Pariksha Bhava ) |
60 days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2022 |
| Date of Study Completion (India) |
23/09/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- Social media are interactive technologies that allow the creation or sharing/exchange of information, ideas, interests, and other forms of expression via virtual communities and networks.
- Social media addiction can be viewed as one form of Internet addiction, where individuals exhibit a compulsion to use social media to excess.
- It is a subcategory of the technology/Internet spectrum of addictions and is defined as a user’s maladaptive psychological state of dependency on the use of social networking sites, which is manifested through an obsessive pattern of seeking and using this social networking sites such that these acts infringe normal functioning and produce a range of typical behavioral addiction symptoms, including withdrawal, relapse, conflict and mood modification.
- Social media Addiction is defined as a behavioral addiction and has been associated with depression, loneliness, narcissism, low self-esteem, poor sleep quality, and low academic performance.
- Major impact of this is that it is affecting teenagers cognitive functioning and making him less social, affects their mental level, behaviour, thinking, memory, attention, learning and perception power.
- Today teenagers are spending most of their time on social media which directly affects their memory, children mostly do not remember many small things as they are mostly concentrated on social media which diverts their mind from other important things, and because of these children’s attention, perception power and attention tends to be weak.
- The nearest possible correlation of Memory in Ayurveda is smruti& medha.
- Recollection of facts which were seen, heard or experienced is known as smruti.
- Chakrapani defines Medha as a type of intellect having the power of retention of knowledge.
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