| CTRI Number |
CTRI/2025/04/085572 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Comprehensive Approach to Attention Deficit Hyperactivity Disorder Management |
|
Scientific Title of Study
|
Effectiveness of an Integrated Protocol in Attention Deficit Hyperactivity Disorder- A Single group Pre test- Post test 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 |
Asha V |
| Designation |
MD Scholar |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Kayachikitsa
VPSV Ayurveda College Kottakkal
Malappuram
Malappuram
KERALA
676501
India |
| Phone |
9037500572 |
| Fax |
|
| Email |
ashav368@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod R |
| Designation |
Professor |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Kayachikitsa
VPSV Ayurveda College Kottakkal
Malappuram
Malappuram
KERALA
676501
India |
| Phone |
9846302667 |
| Fax |
|
| Email |
drvinodvarier@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod R |
| Designation |
Professor |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Kayachikitsa
VPSV Ayurveda College Kottakkal
Malappuram
Malappuram
KERALA
676501
India |
| Phone |
9846302667 |
| Fax |
|
| Email |
drvinodvarier@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ASHA V |
| Address |
VPSV Ayurveda College Kottakkal
Malappuram
Kerala 676501 |
| 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 Thushara Suresh Kumar |
AC Shanmughadas Memorial Ayurvedic Child & Adolescent Care Centre |
Room 3
Mental Health Clinic
Kozhikode
673317
Kozhikode
KERALA |
04952930950
acaccgovtkkd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Indian Systems of Medicine (ISM) |
No Objection Certificate |
| Institutional Ethics Committee (IEC) |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rajanyadi Churna, Reference: Ashtangahridaya uttarasthana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: honey), Additional Information: -(2) Medicine Name: Avipathi Churna, Reference: Ashtangahridaya Kalpasthana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: honey), Additional Information: -(3) Medicine Name: Krimigna Vati, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -(4) Medicine Name: Naladadi Gritha, Reference: Ashtangahridaya uttarasthana, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: -(5) Medicine Name: Brahmidrakshadi Kashaya, Reference: Sahasrayoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 45 D, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
a)Those fulfilling DSM V diagnostic criteria for ADHD
b)Age group between 5 to 12 years
c)No discrimination of sex, religion and economic status
d)Those with informed consent and verbal assent from children who can comprehend
e)Those with informed consent from parents for participants less than 7 years.
|
|
| ExclusionCriteria |
| Details |
a)Epilepsy and other neuro developmental disorders
b)Pervasive developmental disorder
c)Undergoing other psychological and pharmacological interventions
d)Moderate and severe intellectual or developmental disability
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of an Integrated management protocol in Attention Deficit Hyperactivity Disorder when done for 60 days Vanderbilt ADHD Diagnostic Parent Rating Scale |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of an Integrated management protocol in quality of life of parents of ADHD participants using WHO Quality of Life BREF scale |
60 days |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 4 |
|
Date of First Enrollment (India)
|
10/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
For this study, participants would be selected according to inclusion criteria. Participant chosen for the research will be instructed to be administered with the below mentioned treatment accordingly. In first stage, participant will receive Rajanyadi Churna,Avipathi Churna and Krimigna vati for 2 weeks. In second stage, participant will receive Brahmidrakshadi Kashaya and Naladadi Ghritha for 1½ months. Behavioral therapy, parental education, and yoga will be received in this stage. Assessments would be taken on 0th day, 15th day and 61st day. Effectiveness of Integrated Protocol will be assessed using Vanderbilt ADHD Diagnostic Parent Rating Scale (VADPRS). The Effectiveness of Integrated treatment protocol in quality of life of parents of ADHD participants will be assessed using WHO QOL- BREF Scale |