| CTRI Number |
CTRI/2021/07/034641 [Registered on: 06/07/2021] Trial Registered Prospectively |
| Last Modified On: |
03/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurveda treatment for ADHD in children |
|
Scientific Title of Study
|
Clinical study to evaluate the effectiveness of Kushmanda ghrita along with Abhyanga and Shirodhara in Attention Deficit Hyperactivity Disorder in children |
| Trial Acronym |
AY-ADHD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Binisha C |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Room No. 16, Department of Kaumarabhritya
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan – 573201, Karnataka, India
Hassan
KARNATAKA
573201
India |
| Phone |
8281020492 |
| Fax |
|
| Email |
binishachothayoth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailaja Uppinakuduru |
| Designation |
Professor and Head |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Room No. 16, Department of Kaumarabhritya
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan – 573201, Karnataka, India
Hassan
KARNATAKA
Dr Shailaja U
India |
| Phone |
9448816433 |
| Fax |
|
| Email |
rao.shaila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Binisha C |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Room No. 16, Department of Kaumarabhritya
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan – 573201, Karnataka, India
Hassan
KARNATAKA
573201
India |
| Phone |
8281020492 |
| Fax |
|
| Email |
binishachothayoth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjuntheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjuntheshwara College of Ayurveda and Hospital Hassan Karnataka India |
| Address |
Room No. 16, Department of Kaumarabhritya,Sri Dharmasthala Manjuntheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India |
| Type of Sponsor |
Private medical college |
|
|
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 Binisha C |
SDM College of Ayurveda and Hospital |
Room No. 16, Department of Kaumarabhritya, Sri Dharmasthala Manjuntheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India
Hassan
KARNATAKA |
8281020492
binishachothayoth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Ayurveda and Hospital, Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F902||Attention-deficit hyperactivity disorder, combined type. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Abhyanga and Shirodhara with Murchitha tila taila
2. Kushmanda ghrita internally |
Kushmanda ghrita - 5 ml twice daily (below 7 years) for 30 days
Kushmanda ghrita - 10 ml twice daily (above 7 years) for 30 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
• Children of the age group of 3-12 years irrespective of gender, religion, and socioeconomic status.
• The children whose parents are willing to participate in the study and ready to sign the consent form.
|
|
| ExclusionCriteria |
| Details |
• Children with other CNS manifestations like Cerebral palsy with hyperkinetic disorder, history of brain damage and other syndromes affecting CNS.
• Children with impaired vision/ impaired hearing.
• Speech delay due to any other secondary causes.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Attention deficit, hyperactivity and impulsivity |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient well being |
45 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/07/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- 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) - Data will be made available on request.
- For how long will this data be available start date provided 23-01-2023 and end date provided 23-01-2024?
Response (Others) - One year post publication
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The objective of the study is to evaluate the effect of Abhyanga, nadi sweda, shirodhara and Kushmanda ghrita in the management of ADHD in children. 20 subjects with ADHD will be administered with abhyanga, nadi sweda and shirodhara externally and Kushmanda ghrita internally. After the study period of 45 days, the subjects will be assessed for reduction in attention deficit, hyperactivity and impulsivity. |