| CTRI Number |
CTRI/2024/10/074770 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Bal buddhivardhak Yoga in Attention Deficiet Hyperactivity Disorder (ADHD) |
|
Scientific Title of Study
|
Clinical Evaluation Of Bal buddhivardhak Yoga in Attention Deficiet Hyperactivity Disorder (ADHD) |
| 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 Keerti Verma |
| Designation |
Head of Department |
| Affiliation |
Rishikul Campus ,Haridwar |
| Address |
Department of Kaumarbhritya, OPD No10,Rishikul Campus,Devpura, Haridwar, Uttrakhand,249401,
Rishikul Campus, Devpura, Haridwar, Uttrakhand 249401, India
Rishikul Campus ,Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9997777833 |
| Fax |
|
| Email |
keerti.vrm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Keerti Verma |
| Designation |
Head of Department |
| Affiliation |
Rishikul Campus ,Haridwar |
| Address |
Department of Kaumarbhritya, OPD No10,Rishikul Campus,Devpura, Haridwar, Uttrakhand,249401,
Rishikul Campus, Devpura, Haridwar, Uttrakhand 249401, India
Rishikul Campus ,Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9997777833 |
| Fax |
|
| Email |
keerti.vrm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Keerti Verma |
| Designation |
Head of Department |
| Affiliation |
Rishikul Campus ,Haridwar |
| Address |
Department of Kaumarbhritya, OPD No10,Rishikul Campus,Devpura, Haridwar, Uttrakhand,249401,
Rishikul Campus, Devpura, Haridwar, Uttrakhand 249401, India
Rishikul Campus ,Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9997777833 |
| Fax |
|
| Email |
keerti.vrm@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD no 10 kaumarbhritya,Rishikul Campus, Uttrakhand Ayurved University , Haridwar, Uttarakhand
pin code 249401, India |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus |
| Address |
OPD No 10 Kaumarbhritya,Rishikul Campus, Uttrakhand Ayurved University, Haridwar,Pincode 249401 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrKanchan Rawat |
Rishikul Campus |
OPD no 10 and IPD of Kaumarbhritya Department, Rishikul Campus, Haridwar, Uttaranchal
Garhwal
UTTARANCHAL |
09997610625
rawat1kanchan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F99||Mental disorder, not otherwise specified. Ayurveda Condition: MANOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bal Buddhivardhak Yoga, Reference: Harit samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 75 Days, anupAna/sahapAna: Yes(details: -Madhu and Ghirta), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Age between 6 to 12 years, Patient fit for DSM- IV criteria.
|
|
| ExclusionCriteria |
| Details |
Before 6 years and above 12 years children,Children with physical disability,Seizure disorder,Children with diagnosed psychiatric illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical Evaluation of Bal Buddhivardhak Yoga in Attention Deficiet Hyperactivity Disorder(ADHD)
Subjectively all signs & symptoms are given with grading depending upon their severity |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical Evaluation of Bal Buddhivardhak Yoga in Attention Deficiet Hyperactivity Disorder(ADHD)
Subjectively all signs & symptoms are given with grading depending upon their severity. |
Fifteen 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
|
N/A |
|
Date of First Enrollment (India)
|
14/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - All the data will be provided in documentation form by the researcher
- For how long will this data be available start date provided 15-10-2024 and end date provided 30-10-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Attention Deficiet Hyperactivity Disorder (ADHD) is a neuro behavioral disorder in children. It is characterized by inattention,including distractibility and sustaining attention, poor impluse control and decreased self - inhibitory capacity and motor restlessness. In Ayurveda it can be manifested as Manovahasroto Dusti vikar.Here vitiation od Dhi , Dhirti, Smriti occur which causes abnormality and abnormal conduct resulting into improper contact of senses with their objectives. And derangement of all activities of Manas, Buddhi, Ahankar, Indriyas. The Drug for this trial is Bal Buddhivardhak Yoga, and the study aims to evaluate the efficacy of Bal Buddhivardhak Yoga in ADHD cases. Total duration of treatment is 90 days with assessment will be done at interval of 15 days. Patient will be registered from OPD and IPD of PG Department of Kaumarbhritya, Rishikul Campus, Haridwar, Uttrakhand, Ayurved University. |