| CTRI Number |
CTRI/2025/02/080984 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Yoga Practices and Yastimadhu Churna on Cognitive Failures in Daily Life in Adolescents. |
|
Scientific Title of Study
|
A Comparative Study to Determine the Effect of Yoga Practices and Yastimadhu Churna on Smritihras w.s.r Cognitive Failures Experienced in Daily Life in Adolescents: A Randomized, Open Label, Parallel Group, Active Controlled Trial |
| 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 Amit Kumar |
| Designation |
P G Scholar |
| Affiliation |
Government Ayurvedic College and Hospital Kadamkuan Patna Bihar 8000003 |
| Address |
SWASTHAVRITTA AND YOGA Departnment
Government Ayurvedic College and Hospital Kadamkuan Patna Bihar
Patna
BIHAR
800003
India |
| Phone |
7488651667 |
| Fax |
|
| Email |
dr.amitguptapatna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gangadhar singh |
| Designation |
Professor and H.O.D |
| Affiliation |
Government Ayurvedic College and Hospital, Kadamkuan Patna |
| Address |
Department of Swasthavritta and Yoga
Government Ayurvedic College and Hospital Kadamkuan Patna, Bihar
Patna
BIHAR
800003
India |
| Phone |
9431093876 |
| Fax |
|
| Email |
gdsingh1960@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpy Gupta |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College and Hospital, Kadamkuan Patna |
| Address |
Department of Kaumarbhritya
Government Ayurvedic College and Hospital Kadamkuan Patna Bihar
Patna
BIHAR
800003
India |
| Phone |
7830875453 |
| Fax |
|
| Email |
drguptashilpy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar
India
Pin-800003 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital Patna |
| Address |
Department of swasthavritta and yoga
Government Ayurvedic College and Hospital Kadamkuan Patna, Bihar, 800003, India |
| Type of Sponsor |
Other [Government Ayurvedic College and Hospital,Patna] |
|
|
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 Amit Kumar |
Government Ayurvedic College and Hospital |
OPD of Swasthvritta Yoga and Kaumarbhritya
Goverment Ayurvedic College Hospital, Patna
Patna
BIHAR |
7488651667
dr.amitguptapatna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Government Ayurvedic College Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F489||Nonpsychotic mental disorder, unspecified. Ayurveda Condition: PRANAVRUTAVYANAVATAH, (2) ICD-10 Condition:G998||Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: BUDDHIMANDYAMÂ (KEVALA-KAPHA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: None, Ritucarya: None, Acara Rasayana:None, Other:Yoga Practice Yogasana and Pranayam practices mainly-Balasana, Baddha Konasana, Marjaryasansa, Paschimottanasana, Viparita Karani,Bhramari, Anuloma -Viloma, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yastimadhu churna, Reference: Charaka Chikitsa 1, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: milk), Additional Information: NONE |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of age group 10-19 years having history of daily cognitive failures/slips will be screened.
2. Adolescents with otherwise apparently normal mental status.
3. Subjects whose parents are willing to give consent for the trial.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with any mental and systemic physical illness.
2. Subjects on prolonged medication or chronic diseases.
3. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
4. Subjects whose parents are not willing to give consent for clinical trial.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reaction Time and Cognitive Failure Questionnaire Score |
at baseline, 4 weeks & 8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms like Dhyan Shakti, Grahan Shakti, Smaran Shakti etc. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
17/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Cognitive errors contribute to poor mental health and increases the
risk of psychological disorders in later life. In current situation all age
groups suffer from these neuro-cognitive conditions. The
main aim of this study is to promote and spread the awareness about maintenance
of mental health and prevention from the earlier causation of mental diseases. So, the present study was
conducted to find the effect of Yoga practice and Yastimadhu
Churna on
sensory-motor coordination in the form of visual reaction time (VRT) and
auditory reaction time (ART) in healthy adolescents. |