| CTRI Number |
CTRI/2023/08/056470 [Registered on: 14/08/2023] Trial Registered Prospectively |
| Last Modified On: |
08/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of brahmi Ghrita & ashtang ghrita in Attention Deficit Hyperactive Disorder in children |
|
Scientific Title of Study
|
A Comparative Clinical Study On The Effect Of Ashtanga Ghritam & Brahmi Ghritam In Children Suffering From Attention Deficit Hyperactive 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 Priyanka Wadhwa |
| Designation |
PhD Scholar |
| Affiliation |
Parul University |
| Address |
Dept of Balroga, Faculty Campus, Parul Institute of Ayurveda, Parul University, Limda, Vadodara
OPD Balroga, Parul Institute of Ayurveda, Parul University, limda, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8105938269 |
| Fax |
|
| Email |
pwadhwa13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnil Raskar |
| Designation |
Associate professor |
| Affiliation |
Parul University |
| Address |
Dept of Balroga, Faculty Campus, Parul Institute of Ayurveda, Parul University
OPD BALROGA, Parul Institute Of Ayurveda, parul University
Vadodara
GUJARAT
391760
India |
| Phone |
8105938269 |
| Fax |
|
| Email |
neonatecare99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Wadhwa |
| Designation |
PhD Scholar |
| Affiliation |
Parul University |
| Address |
Dept of Balroga, Faculty Campus, Parul Institute of Ayurveda, Parul University, Limda, Vadodara
OPD Balroga, Parul Institute of Ayurveda, Parul University, Limda, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8105938269 |
| Fax |
|
| Email |
pwadhwa13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurveda, Parul university, limda, vadodara, Gujrat
pin:- 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Wadhwa |
| Address |
Patanjali Ayurveda College,
Haridwar, Uttrakhand
Pin:- 249405 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Swapnil Raskar |
Associate professor,
Parul Institute of Ayurveda,
Parul University, Vadodara, Gujrat
391760 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka wadhwa |
Parul Institute Of Ayurveda |
OPD Balroga, Parul Institute Of Ayurveda, Limda, Vadodara, Gujrat
PIN:_391760
Vadodara
GUJARAT |
8105938269
pwadhwa13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Parul Institute Of Ayurveda, Parul University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F909||Attention-deficit hyperactivity disorder, unspecified type. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashtang Ghrita, Reference: Ashtang Hridyam, uttar tantra 1/43-44, Route: Oral, Dosage Form: Ghrita, Dose: 16(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Brahmi Ghrita, Reference: Bhaishjya Ratnavli, Apasmara Chikitsa, Route: Oral, Dosage Form: Ghrita, Dose: 16(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
-Children of either sex
-Children of age group of 6 - 12 years
-Children diagnosed to be suffering from ADHD as per The Diagnostic and Statistical Manual of Mental Disorders (DSM) V criteria
|
|
| ExclusionCriteria |
| Details |
-Mentally retarded children
-Children suffering from any neurological disease
-Children suffering from any severe hepatic / cardiac or renal condition.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Score as per DSM V CRITERIA |
day 15
day 30
day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hyperactivity of Child
Impulsivity of child |
day 15
day 30
day 45 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
21/08/2023 |
| 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="0"
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
|
•Attention
Deficit Hyperactivity Disorder (ADHD) is characterized by a persistent pattern
of inattention and/or hyperactivity-impulsivity that is frequently displayed
and more severe than that typically observed in individuals at a comparable
level of development.
•Various studies have reported
prevalence of ADHD in Indian Children varying between 3% to 8%. Again being one
of the commonest neurobehavioral disorder of childhood, ADHD comprises perhaps
50% of referrals to child neurologists, behavioural therapist and child
psychiatrists.
•This
disorder is found to be a forerunner of a number of different psychiatric
conditions including mood disorders, anxiety disorders and some types of
schizophrenia.The
symptoms usually become evident in preschool or early years. The median age of
onset being 7 years. •In view
of the adverse effects associated with psycho-stimulants used for the treatment
of this disorder, there arises a need of an effective treatment modality.
•Thus this
study has been up taken to evaluate the efficacy of Ashtang Ghrita in this
condition.
|