| CTRI Number |
CTRI/2025/08/092890 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on the effectiveness of Brahmi Ghrita and Saraswata churna in children with Attention Deficit Hyperactivity Disorder aged 6-12 years in a sample of 21 individuals |
|
Scientific Title of Study
|
Effect of Brahmi Ghrita and Saraswata Churna in Children with Attention Deficit Hyperactivity Disorder aged 6-12 years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Rose CJ |
| Designation |
MD SCHOLAR |
| Affiliation |
Govt. Ayurveda College Thiruvananthapuram |
| Address |
Department of Kaumarabhritya, Govt. Ayurveda College Women and Children Hospital Poojappura, Thiruvananthapuram Kerala
695012
India
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9567362633 |
| Fax |
|
| Email |
poojarosechelakkara26@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sohini S |
| Designation |
Associate Professor |
| Affiliation |
Govt Ayurveda College Thiruvananthapuram |
| Address |
Department of Kaumarabhritya, Govt. Ayurveda College Women and Children Hospital Poojappura, Thiruvananthapuram Kerala
695012
India
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9447657471 |
| Fax |
|
| Email |
drsohini30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sohini S |
| Designation |
Associate Professor |
| Affiliation |
Govt Ayurveda College Thiruvananthapuram |
| Address |
Department of Kaumarabhritya, Govt. Ayurveda College Women and Children Hospital Poojappura, Thiruvananthapuram Kerala
695012
India
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9447657471 |
| Fax |
|
| Email |
drsohini30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Ayurveda College Women and Children Hospital Poojappura, Thiruvananthapuram Kerala , 695012, India |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Rose CJ |
| Address |
Department of Kaumarabhritya, Govt. Ayurveda College Women and Children Hospital Poojappura, Thiruvananthapuram Kerala , 695012, India |
| Type of Sponsor |
Other [Govt. Ayurveda College Thiruvananthapuram] |
|
|
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 Pooja Rose CJ |
Govt. Ayurveda College Thiruvananthapuram, Women and Children Hospital Poojappura |
Department of Kaumarabhritya, Govt. Ayurveda College Women and Children Hospital Poojappura, Thiruvananthapuram Kerala
Thiruvananthapuram
KERALA |
09567362633
poojarosechelakkara26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, GOVT. AYURVEDA COLLEGE THIRUVANANTHAPURAM(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: BRAHMI GHRITA , Reference: Ashtanga Hrdaya Uttarasthana Unmada Prathishedha, Route: Oral, Dosage Form: Ghrita, Dose: 200(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: -(2) Medicine Name: SARASWATA CHURNA , Reference: Bhaishajya Ratnavali Unmada Chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 100(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
i. Children diagnosed with Attention Deficit Hyperactivity Disorder of the age group of 6 to 12 years according to DSM-5 criteria |
|
| ExclusionCriteria |
| Details |
i. Presence of any other psychiatric comorbidity.
ii. Presence of any other organic problem or brain damage
iii. Diagnosed cases of mental retardation
iv. Patients with other diagnosed genetic disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in features of Attention Deficit Hyperactivity Disorder assessed using the ADHDT-2 scale
and Vanderbilt ADHD Diagnostic Parent Rating Scale (VADPRS).
|
Assessment of ADHD features before and after study and after follow- up will be done by using the ADHDT-2 scale and the Vanderbilt ADHD diagnostic parent rating scale (VADPRS). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="1"
Months="1"
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
|
Children with an age group of 6- 12 years satisfying the DSM 5 criteria for ADHD will be selected for the study from the OPD of Government Ayurveda College Hospital for Women and Children, Poojappura, Informed consent will be taken from the parents of the selected participants. The participants in the study group will be made fit to take the ghrita yoga after administering ashtachurna [age-appropriate dose] having Deepana-pachana property for the correction of Agni, for a period of 5 days. Then the participants will be administered with Brahmi Ghrita in age-appropriate dose twice daily with lukewarm water as anupana before food and Saraswata Churna in age-appropriate dose twice daily with honey as anupana after food depending upon the age of the child. They will be advised on dietary regulations for ADHD. Assessment of ADHD features before and after study and after follow- up will be done by using the ADHDT-2 scale and the Vanderbilt ADHD diagnostic parent rating scale (VADPRS). Trial drug will be given for sixty days. Further, the data will be collected, scored, and statistically analyzed using appropriate statistical techniques. |