| CTRI Number |
CTRI/2025/06/089402 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ayurvedic medicine in ADHD in children of age 6 to 12 years |
|
Scientific Title of Study
|
Randomized controlled trial to evaluate the efficacy of Dheeradi Ghrita in the management of Attention Deficit Hyperactivity Disorder(ADHD) in children of age group 6 to 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 Anjali Pratap Thawrani |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala ayurved mahavidyalaya |
| Address |
OPD number 4, kaumarbhritya department , siddhakala ayurved mahavidyalaya, pimparane road, sangamner,ahmadnagar, maharashtra, India 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
09404563407 |
| Fax |
|
| Email |
anjalithawrani1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Rajesh Prabhakar Bholane |
| Designation |
HOD Kaumarbhritya |
| Affiliation |
Siddhakala ayurved mahavidyalaya |
| Address |
Bholane hospital, Tajane mala, New nagar road, Sangamner, Ahmadnagar, Maharashtra, India 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9822334742 |
| Fax |
|
| Email |
drrajeshbholane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Rajesh Prabhakar Bholane |
| Designation |
HOD Kaumarbhritya |
| Affiliation |
Siddhakala ayurved mahavidyalaya |
| Address |
Bholane hospital, Tajane mala, New nagar road, Sangamner, Ahmadnagar, Maharashtra, India 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9822334742 |
| Fax |
|
| Email |
drrajeshbholane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala ayurved mahavidyalaya, Sangamner , Dist Ahmednagar , state Maharashtra, India, pin code 422605 |
|
|
Primary Sponsor
|
| Name |
Anjali Pratap Thawrani |
| Address |
Siddhakala Ayurved Mahavidyalaya, Pimparane road, Sangamner khurd, Sangamner, Ahmadnagar, Maharashtra, India 422605 |
| 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 Anjali Pratap Thawrani |
Siddhakala Ayurved Mahavidyalaya, Sangamner |
Kaumarbhritya OPD, siddhakala ayurved mahavidyalaya, pimparane road, sangamner,ahmadnagar, maharashtra, India 422605
Ahmadnagar
MAHARASHTRA |
09404563407
anjalithawrani1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board of Ayurved Research and Statistics Committee of Siddhakala Ayurved Mahavidyalaya, Sangamner |
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: BALAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Shankhapushpi and jatamansi siddha ghrita, Reference: NA, Route: Oral, Dosage Form: Ghrita, Dose: 4(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Dheeradi Ghrita, Reference: NA, Route: Oral, Dosage Form: Ghrita, Dose: 4(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 6 to 12 yrs.
Patient irrespective of their gender, religion and socioeconomic status.
Patients having Symptoms of ADHD for at least last 6 months.
Patients that fit in DSM IV criteria for diagnosis.
Children with no other neurological condition like mental retardation, down syndrome, microcephaly, etc. |
|
| ExclusionCriteria |
| Details |
Any serious neurological disease diagnosed earlier like cerebral palsy, mental retardation, microcephaly.
Any kind of systemic disease or chronic systemic disease like nephrotic syndrome, type 1 diabetes melitus.
disobedient parents. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Dheeradi Ghrita in ADHD |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To understand the disease ADHD in detail.
To find out ayurvedic correlation of disease with doshas and dushya.
To understand samprapti of disease.
To find better treatment options for ADHD.
To create awareness of disease ADHD.
|
15 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
09/07/2025 |
| 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="6"
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
|
This study is a randomized open labelled controlled clinical trial comparing the safety and efficacy of Dheeradi ghrita 4ml thrice a day with koshna jala and controlled shankhpushpi and jatamansi siddha ghrita 4ml thrice a day with koshna jala for 45 days in 60 children of age group 6 to 12 yrs with Attention Deficit Hyperactivity Disorder (ADHD) |