| CTRI Number |
CTRI/2018/05/014001 [Registered on: 21/05/2018] Trial Registered Prospectively |
| Last Modified On: |
18/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Survey and comparative study to Evaluate the efficacy of Ayurvedic formulation and Shirodhara in Attention Deficit Hyperactivity Disorder. |
|
Scientific Title of Study
|
Survey and Intervention study to Evaluate the efficacy of Ayurvedic
formulation and Shirodhara in Attention Deficit Hyperactivity Disorder.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Kumar Nagar |
| Designation |
Assistant Professor |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA, JAIPUR |
| Address |
P.G.DEPARTMENT OF Kaumarabhritya,NATIONAL INSTITUTE OF
AYURVEDA,JAIPUR, NEAR JORAWAR SINGH GATE,MADHAV
VILAS,AAMER ROAD, JAIPUR,RAJASTHAN ,PIN-302002, india
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414062099 |
| Fax |
|
| Email |
drrknagar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Omprakash Bairwa |
| Designation |
P.G. Scholar |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA, JAIPUR |
| Address |
P.G.DEPARTMENT OF Kaumarabhritya,NATIONAL INSTITUTE OF
AYURVEDA,JAIPUR, NEAR JORAWAR SINGH GATE,MADHAV
VILAS,AAMER ROAD, JAIPUR,RAJASTHAN ,PIN-302002, india
Jaipur
RAJASTHAN
P.G.DEPARTMENT OF Kaumarabhritya,NATIONAL INSTITUTE OF
AYURVEDA,JAIPUR, NEAR JORAWAR SINGH GATE,MADHAV
VILAS,AAMER ROAD, JAIPUR,RAJASTHAN ,PIN-302002, india
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302002
India |
| Phone |
9005352090 |
| Fax |
|
| Email |
op.muskan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Omprakash Bairwa |
| Designation |
P.G. Scholar |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA, JAIPUR |
| Address |
P.G.DEPARTMENT OF Kaumarabhritya,NATIONAL INSTITUTE OF
AYURVEDA,JAIPUR, NEAR JORAWAR SINGH GATE,MADHAV
VILAS,AAMER ROAD, JAIPUR,RAJASTHAN ,PIN-302002, india
Jaipur
RAJASTHAN
P.G.DEPARTMENT OF Kaumarabhritya,NATIONAL INSTITUTE OF
AYURVEDA,JAIPUR, NEAR JORAWAR SINGH GATE,MADHAV
VILAS,AAMER ROAD, JAIPUR,RAJASTHAN ,PIN-302002, india
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302002
India |
| Phone |
9005352090 |
| Fax |
|
| Email |
op.muskan@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda, Jaipur, Rajasthan, 302002 |
|
|
Primary Sponsor
|
| Name |
Dr Rakesh Kumar Nagar |
| Address |
P.G. Department of Kaumarabhritya, National Institute of Ayurveda,
Jaipur, Rajasthan- 302002 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Omprakash Bairwa |
P.G. Department of Kaumarabhritya, National
Institute of Ayurveda, Jaipur,Rajasthan- 302002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh Kumar Nagar |
national institute of ayurveda jaipur |
opd room no. 05
department of kaumarabhritya
Jaipur
RAJASTHAN |
9414062099
drrknagar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee national institute of ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ADHD(Attention Deficit Hyperactivity Disorder), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Shirodhara |
15 days and followed by once in a week for 3 month in the morning with milk for 45 minutes |
| Intervention |
Tab ELEVA (Dr Vasisth pharma) |
Dose-1 Tablet twice a day with Honey after meal for 3 Month. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) School children aged between 6 to 12 years.
2) Having sign and symptoms for ADHD.
3) Children with average/normal IQ |
|
| ExclusionCriteria |
| Details |
1) Children with known physical disability (
deafness or visual problems)
2) Children with psychiatric disorders.
3) Children with gross brain damage causing
mental retardation.
4) Children with any genetic disorder
5) Children with
• Epilepsy
• on chronic medication(e.g. steroids)
• previous history of an infectious disease
involving central nervous system (e.g.
encephalitis)
• intellectual disability
• autism
6) Unreliable history.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To study the prevalence of ADHD in school children (6-12 years) in Jaipur, Rajasthan.
2) To study the gender difference in prevalence of ADHD.
3) To assess the efficacy of tab. Eleva and Shirodhara in Attention Deficit Hyperactivity Disorder.
|
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To provide relief in the symptoms of ADHD |
3 Months |
|
|
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 2 |
|
Date of First Enrollment (India)
|
28/05/2018 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Attention deficit hyperactivity disorder (ADHD) is a mental disorder of the neurodevelopmental type. The core symptoms of ADHD are inattention, hyperactivity, and impulsivity. It is one of the most common and most extensively studied behavioral disorders in school age children. Genetic, epigenetic, and environmental factors interact to give rise to the ADHD phenotypes. Biological and psychosocial factors also contribute to ADHD. Prenatal exposure to alcohol, cocaine, and nicotine are associated with ADHD phenotypes. Studies of prevalence of ADHD across the globe have generally reported that 9% of school age children are affected, may result of differing sampling and testing techniques. ADHD is highly prevalent in children worldwide and prevalence in adults is increasingly recognized. |