| CTRI Number |
CTRI/2025/10/096436 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Takradhara and Brahmi Ghrita in Reducing Symptoms of Attention dificit and Hyperactive Disorder |
|
Scientific Title of Study
|
Clinical Evaluation of the Efficacy of Takradhara in Attention Deficit Hyperactive Disorder |
| 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 Vijayalaxmi Benakatti |
| Designation |
Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital Research Centre Vijayapura |
| Address |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital Research Centre Vijayapura
Dept of Kaumarabhrutya
Room No 4
Vidyanagar
Bagalkot Road Vijayapura
Bijapur
KARNATAKA
586109
India |
| Phone |
8762977008 |
| Fax |
|
| Email |
vbbenakatti1981@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalaxmi Benakatti |
| Designation |
Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital Research Centre Vijayapura |
| Address |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital Research Centre Vijayapura
Dept of Kaumarabrutya
Room no 4
Vidyanagar
Bagalkot Road Vijayapura
Bijapur
KARNATAKA
586109
India |
| Phone |
8762977008 |
| Fax |
|
| Email |
vbbenakatti1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayalaxmi Benakatti |
| Designation |
Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital Research Centre Vijayapura |
| Address |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital Research Centre Vijayapura
Dept of Kaumarabhrutya
Room no 4
Vidyanagar
Bagalkot Road Vijayapura
Bijapur
KARNATAKA
586109
India |
| Phone |
8762977008 |
| Fax |
|
| Email |
vbbenakatti1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDE Deemed to be University
Smt Bangaramma Sajjan campus
B M Patil road
Vijayapura
State Karnataka
Conutry India
Pin code 586103 |
|
|
Primary Sponsor
|
| Name |
BLDE Deemed to be University Vijayapura |
| Address |
Smt Bangaramma Sajjan Campus
B M Patil road Solapur road Vijayapura
State Karnataka
Country India
Pin code 586103 |
| Type of Sponsor |
Other [BLDE DU University Vijayapura] |
|
|
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 Vijayalaxmi Benakatti |
BLDEAs AVS Ayurveda Mahavidyalaya hospital adn research centre vijayapura |
Dept of Kaumarabhrutya
Room no 4
Bijapur
KARNATAKA |
8762977008
vbbenakatti1981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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: VATAJA-UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | takradhArA, तक्रधारा | (Procedure Reference: R H Singh Keraliyapanchakarma published CCRAS Newdelhi Chaukhambha sanskrit series Varanasi page no 188, Procedure details: Preoperative procedure - Takra is prossed with ashwagandha vacha brahmi jatamansi and prepare medicated takra Operative procedure - Praepared takra is filled in dharapatra and continously pour the takra over forehead in uniformaly and slowly by moving the dharaoatra. inbetween massage of scalp tobe done. continue procedure for 30mins.
Post operative wipe the head with dry towel and apply rasna churna over vertex.)
(1) Medicine Name: Brahmi ghrita, Reference: Astanhahridayam uttarstana 6chapter 23 to 25 shloka , Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Duration: 90 Days |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1 Children aged between 6-16 years of age
2 Children fulfilling the DSM-V criteria for diagnosis of ADHD.
3 Parents who are willing for treatment and giving concern |
|
| ExclusionCriteria |
| Details |
1 Children under other medications or interventions such as behavior
therapy are excluded from the study.
2 Children with mild to severe mental retardation conduct disorders,
3 Pervasive disorder and other Psychotic disorders are excluded.
4 Children with chronic ailments like tuberculosis, malignancy etc.are excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in attention Decrease in hyperactivity and impulsivity |
After 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in concentration and academic school performance |
after 90 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 3 |
|
Date of First Enrollment (India)
|
04/11/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The present study aims to evaluate the efficacy of Takradhara in
Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a common
neurodevelopmental disorder characterized by inattention, hyperactivity, and
impulsivity, leading to academic, behavioral, and social difficulties in
children. Takradhara, a Ayurvedic therapy involving the continuous pouring of
medicated buttermilk over the forehead for 7days followed by Brahmi ghrita oral
administration for 30 days will helps to calm, reduce stress and enhance
concentration in children. The sample will be collected from our hospital of
both gender, age 6yrs to 16yrs. Those who fulfil the inclusive will be included
in the study. Sample size is 20. This study is designed to assess its role as in
ADHD.The primary outcome will focus on the reduction of ADHD symptoms
(inattention, hyperactivity, impulsivity) assessed using standardized rating
scales. The secondary outcomes include improvement in cognitive functions,
behavior, quality of life |