| CTRI Number |
CTRI/2025/04/085991 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Ayurveda and Standard Treatment for Managing ADHD in Children: A Clinical Trial |
|
Scientific Title of Study
|
Evaluation of ayurveda treatment protocol in the management of Attention Deficit/Hyperactivity Disorder in children- A Randomized Controlled Clinical Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SONU PRAKASH |
| Designation |
Assistant Professor |
| Affiliation |
KAHERS SHRI B.M KANKANWADI AYURVEDA MAHAVIDYALAYA |
| Address |
Room no. 2, 3rd floor, Department of Kaumarbhritya, KAHERS SHRI B.M KANKANWADI AYURVEDA MAHAVIDYALYA, SHAHPUR, BELAGAVI, KARNATAKA-590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9560225819 |
| Fax |
|
| Email |
sp2277423@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basavaraj Tubaki |
| Designation |
Professor and Head |
| Affiliation |
KAHERS SHRI B.M KANKANWADI AYURVEDA MAHAVIDYALAYA |
| Address |
Room no. 1, 2nd floor, Department of Kayachikitsa, KAHERS SHRI B.M KANKANWADI AYURVEDA MAHAVIDYALYA, SHAHPUR, BELAGAVI, KARNATAKA-590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9448634660 |
| Fax |
|
| Email |
basavarajtubaki.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basavaraj Tubaki |
| Designation |
Professor and Head |
| Affiliation |
KAHERS SHRI B.M KANKANWADI AYURVEDA MAHAVIDYALAYA |
| Address |
Room no. 1, 2nd floor, Department of Kayachikitsa,KAHERS SHRI B.M KANKANWADI AYURVEDA MAHAVIDYALYA, SHAHPUR, BELAGAVI, KARNATAKA-590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9448634660 |
| Fax |
|
| Email |
basavarajtubaki.kaher@kleayurworld.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sonu Prakash |
| Address |
KAHERS SHRI B.M KANKANWADI AYURVEDA MAHAVIDYALYA, SHAHPUR, BELAGAUM, KARNATAKA-590003 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sonu Prakash |
Kahers Shri B.M.K Ayurveda Mahavidyalya |
OPD-10, Department of Kaumarbhritya,Kahers Shri BM Kankanwadi Ayurveda Mahavidyalya,Shahpur, Belgavi- 590003
Belgaum
KARNATAKA |
9560225819
sp2277423@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER ethics committee (human) for PhD |
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: unmad, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sahacharadi taila , Reference: charak, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Dashmoola Kwatha, Reference: cahark, Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 30(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -(3) Medicine Name: Panchagavya Ghrita , Reference: charaka, Route: Rectal, Dosage Form: Ghrita, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -(4) Medicine Name: Godugdha, Reference: charak, Route: Topical, Dosage Form: Ksheerpaka, Dose: 500(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -(5) Medicine Name: Panchgavya Ghrita, Reference: charak, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 53 Days, anupAna/sahapAna: No, Additional Information: -(6) Medicine Name: Jatamansi churna , Reference: charak, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 53 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Control Group | Medicine Name: Methylphenidate |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) Children of either sex between the age group of 6-12 years.
2) Children fulfilling the DSM-V diagnostic criteria for diagnosis of ADHD. |
|
| ExclusionCriteria |
| Details |
1) Children with an acute or chronic, local or systemic infection will be excluded.
2) Children who are currently using other medications will be excluded owing to the possibility
of drug interaction.
3) Known case of cerebral palsy, mental retardation and epilepsy, hearing defect etc.
4) Children with obvious congenital anomalies like cleft palate, CHD etc.
5) Children who have received any form intervention for ADHD in last 3 months. |
|
|
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 |
To compare the effect of Ayurveda Treatment protocol and Methylphenidate in
management of ADHD in children assessed through SNAP IV Rating Scale. |
baseline, 7th day, 30th day, 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effect of Ayurveda Treatment protocol in management of ADHD in children
by assessing the reaction time through Vernier Chronoscope
2. To evaluate the effect of Ayurveda Treatment protocol in management of ADHD in children
by assessing the Functional impairments through Weiss Functional Impairment Rating Scale
3. To evaluate the effect of Ayurveda Treatment protocol in management of ADHD in children
by assessing the Co-morbidities through Kiddie-SADS–Present & Lifetime Version
4. To evaluate the effect of Ayurveda Treatment protocol in management of ADHD in children
by assessing the Health-related quality of life through PedsQL
5. To evaluate the effect of Ayurveda Treatment protocol in management of ADHD in children
by assessing the severity & improvement through CGI scales |
1. baseline, 7th day, 30th day, 60th day
2. baseline, 60th day
3. baseline, 60th day
4. baseline, 60th day
5. baseline, 60th day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
18/05/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Title: Comparative Study on the Effect of Ayurveda Treatment Protocol and Methylphenidate in the Management of ADHD in Children
Background:
Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder in children, characterized by inattention, hyperactivity, and impulsivity. While methylphenidate is the standard pharmacological treatment, it is associated with significant side effects. Due to these concerns, many parents seek alternative therapies, including Ayurveda. Ayurvedic texts compare ADHD to Unmada, and suggest various therapies for its management.
Aim:
To evaluate and compare the effectiveness of an Ayurveda treatment protocol and methylphenidate in managing ADHD in children.
Objectives:
-
Primary: Compare outcomes using the SNAP IV Rating Scale.
-
Secondary: Assess reaction time (Vernier Chronoscope), functional impairment (Weiss Scale), comorbidities (Kiddie-SADS), quality of life (PedsQL), and severity/improvement (CGI scales).
Methodology:
-
Design: Randomized Controlled Clinical Trial
-
Participants: 80 children aged 6–12 years with ADHD (diagnosed per DSM-5), randomized into two groups
-
Setting: KLE Shri BMK Ayurveda Hospital, Belagavi
-
Duration: 28 months
-
Groups:
-
Group A: Ayurveda protocol including Abhyanga, Swedana, Basti, Shirodhara, Nasya, and oral Jatamansi
-
Group B: Oral methylphenidate (1 mg/kg/day)
-
Duration of Intervention: 60 days
-
Outcome Measures: Clinical scales, reaction time, comorbidities, and quality of life
Inclusion Criteria:
Children aged 6–12 with DSM-5 ADHD diagnosis.
Exclusion Criteria:
Children with infections, comorbid neurological or congenital conditions, or those on current ADHD medication.
Significance:
This study aims to provide evidence for the efficacy and safety of Ayurveda as an alternative to conventional pharmacotherapy in managing ADHD |