| CTRI Number |
CTRI/2025/10/096510 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
a study to see how well balakanaka patradi kashaya works for people with internet gaming disorder |
|
Scientific Title of Study
|
“AN OPEN LABELLED CLINICAL STUDY TO EVALUATE THE EFFECT OF BALAKANAKA PATRADI KASHAYA IN SHEELA VIBHRAMA W.S.R TO INTERNET 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 Nikhil R Dodamani |
| Designation |
MD scholar (manasaroga) |
| Affiliation |
sdm college of ayurveda udupi |
| Address |
OPD3, Dept of Manasaroga, Shri Dharmasthala Manjunatheshwara college of ayurveda, hospital and research center, Kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8660202542 |
| Fax |
|
| Email |
nikhildoddamani99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhaneshwari H A |
| Designation |
Assistant professor |
| Affiliation |
sdm college of ayurveda udupi |
| Address |
OPD3, Dept of Manasaroga, Shri Dharmasthala Manjunatheshwara college of ayurveda, hospital and research center, Kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9900554202 |
| Fax |
|
| Email |
drdhaneshwarisdm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhaneshwari H A |
| Designation |
Assistant professor |
| Affiliation |
sdm college of ayurveda udupi |
| Address |
OPD3, Dept of Manasaroga, Shri Dharmasthala Manjunatheshwara college of ayurveda, hospital and research center, Kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9900554202 |
| Fax |
|
| Email |
drdhaneshwarisdm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara ayurveda pharmacy, laxminarayana nagar P.O Kuthpady, Udupi, Karnataka, India 574118 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Nikhil R Dodamani |
SDM ayurveda hospital udupi |
OPD3, Dept of Manasaroga, Shri Dharmasthala Manjunatheshwara college of ayurveda, hospital and research center, Kuthpady, Udupi
Udupi
KARNATAKA |
8660202542
nikhildoddamani99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITEE- HUMAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F638||Other impulse disorders. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: balakanaka patradi kashaya , Reference: sahasrayoga kashaya prakarana , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -hotwater), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling criteria of Internet gaming addiction as per DSM-5
2. Patients are selected of age group between 18-30 years
3. Patients willing to sign informed consent. |
|
| ExclusionCriteria |
| Details |
1. Gambling disorder.
2. Excessive use of internet for required activities in a business or profession.
3. Use of internet for other recreational purpose or social use.
4. Sexual internet sites. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of in Balakanaka patradi kasahaya in Sheela vibhrama W.S.R Internet gaming disorder.
|
before treatment, 15th day and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduce screen time |
30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/11/2025 |
| 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="1"
Months="2"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Sharira and Manas1 are two main constituents of living being. The person is said to be healthy if he
has equilibrium condition of Dosha, Dhatu, Mala, Agni, Prasannata of Atma, Indriya and Manas2.
Manas is invisible and imperceptible, so it is called Atindriya. Manas has three components Satva,
Rajas , Tamas 3. The latter two that is rajas and tamas are dosha. If these components get disturbed by
Apathya ahara, vihara, and dhi, dhruthi, smrithi4, Or any other wrong behavioural conducts leading to
prajnaparada thus causing manovikara.
One among the manoroga is Unmada5. When the manas gets distracted in a person with Alpa satva or
Heena satva6 (weak mental strength or courage) develops the disease unmada. Unmada is a disease
which includes cluster of symptoms, they are Ashtavibhrama. One among the ashta vibhrama is Sheela
vibhrama. Here Sheela7 is inherent character for things, Anusheelana is repeated or compulsive
devoted action. This character for things and compulsive devoted action can be taken as compulsive
behaviour. On withdrawal of compulsive action which causes change in the temperament,
Digital games have become widely popular with more than 10.1%8 people playing at different levels of
involvement across the globe. As for most of the people gaming is a positive recreational activity,
however few children and adolescent manifests addiction like engagement in gaming with association
to difficulty in everyday functioning. Internet gaming addiction is one among the behavioural addiction
others include Gambling, Television compulsion, Internet addiction, adult content except not addicted
to substance, but he/she is addicted to behaviour or feeling experienced by acting out the behaviour.
This compulsive behaviour for gaming can be considered as Sheela vibhrama9.
The prevalence rate of IGD varies worldwide with estimates ranging from 0.2% to 8.5%. As DSM-5
has classified Internet gaming disorder in condition for further study, If this internet gaming
compulsion is not intervened, then it may lead to various psychiatric conditions. hence there is need for
detailed study in field for curative aspect of Internet gaming disorder with respect to Sheela vibhrama.
This study is planned to evaluate the effect of Balakanaka patradi Kashaya10 in IGD with
withdrawal and Sheela vibhrama. |