| CTRI Number |
CTRI/2022/07/044380 [Registered on: 27/07/2022] Trial Registered Prospectively |
| Last Modified On: |
18/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of hyperactive children |
|
Scientific Title of Study
|
Clinical study to evaluate the effectiveness of Saraswatha choorna along with Abhyanga Parisheka and Shirodhara in Attention Deficit Hyperactivity Disorder in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vandana Lakshmi |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Room No.18, Department of Kaumarabhritya
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Thanniruhalla, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9496200821 |
| Fax |
|
| Email |
vandanalakshmi1710@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailaja Uppinakuduru |
| Designation |
Professor and Vice Principal |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Kaumarabhritya, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan – 573201, Karnataka, India
Thanniruhalla, Hassan – 573201, Karnataka, India
Hassan
KARNATAKA
573201
India |
| Phone |
9448816433 |
| Fax |
|
| Email |
rao.shaila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailaja Uppinakuduru |
| Designation |
Professor and Vice Principal |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Kaumarabhritya, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan – 573201, Karnataka, India
Thanniruhalla, Hassan – 573201, Karnataka, India
KARNATAKA
573201
India |
| Phone |
9448816433 |
| Fax |
|
| Email |
rao.shaila@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka |
| 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 Vandana Lakshmi |
SDM College of Ayurveda and Hospital |
Room no. 18, Department of Kaumarabhritya, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan
Hassan
KARNATAKA |
9496200821
vandanalakshmi1710@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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NA |
| Intervention |
Saraswatha choorna (internally), Abhyanga, Parisheka, Shirodhara |
1. Externally Abhyanga with Murchita Tila Taila for 30 minutes followed by Parisheka with Balamoola Kashaya.
2. Shirodhara with Murchita Tila Taila for 30 minutes.
Above said management is done in 2 courses, each of 7 days with a gap of 16 days.
3. Saraswatha Choorna for 30 days along with Gritha and Madhu twice a day before food.
Total duration - one month |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of the age group of 3-8years irrespective of gender, religion, socioeconomic status and fulfilling the diagnostic criteria.
2. The children whose parents are willing to participate in the study and ready to sign the consent form.
|
|
| ExclusionCriteria |
| Details |
1. Children with other CNS manifestations like Cerebral palsy with hyperkinetic disorder, history of brain damage and other syndromes affecting CNS.
2. Children with impaired vision/ impaired hearing. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in CONNERS PARENT RATING SCALE REVISED (CPRS-R) |
1st and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in CONNERS PARENT RATING SCALE REVISED (CPRS-R) |
8th and 22th day |
|
|
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)
|
01/08/2022 |
| 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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 - Proposals should be directed to [vandanalakshmi1710@gmail.com].
- For how long will this data be available start date provided 17-01-2025 and end date provided 31-12-2025?
Response (Others) - Onw 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 clinically evaluate the effectiveness of Saraswatha choorna along with Abhyanga, Parisheka and Shirodhara in Attention deficit hyperactivity disorder (ADHD) in children. 20 subjects diagnosed with ADHD will be administered with Saraswatha choorna internally and Abhyanga and Shirodhara with Murchita tila taila and Parisheka with Balamoola Kashaya. Abhyanaga, Parisheka and Shirodhara will be done for first seven days and last seven days with a gap of 16 days. The assessment was made using Conners Parent Rating Scale. |