| CTRI Number |
CTRI/2026/02/104239 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of siddhartaka ghrita nasya in children with attention deficit hyperactivity disorder |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Siddhartaka ghrita nasya in children with attention deficit hyperactivity 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 Prasad Rajesh Bharambe |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya |
| Address |
OPD No. 14 Kaumarbhritya department, C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road, Chh.Sambhajinagar, 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9370123772 |
| Fax |
|
| Email |
drprasadbharambe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karuna Sunil Ratnaparkhi |
| Designation |
HOD and Professor |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya |
| Address |
OPD No. 14 Kaumarbhritya department, C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road, Chh.Sambhajinagar, 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8668274507 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karuna Sunil Ratnaparkhi |
| Designation |
HOD and Professor |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya |
| Address |
OPD No. 14 Kaumarbhritya department, C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road, Chh.Sambhajinagar, 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8668274507 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No. 14 Kaumarbhritya department, C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road, Chh.Sambhajinagar, 431011 |
|
|
Primary Sponsor
|
| Name |
Dr Prasad Rajesh Bharambe |
| Address |
OPD No. 14 Kaumarbhritya department, C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road, Chh.Sambhajinagar, 431011 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CSMSS Ayurved Mahavidyalaya and Rugnalaya Chh Sambhajinagar |
OPD No. 14 Kaumarbhritya department, C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road, Chh.Sambhajinagar, 431011 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prasad Rajesh Bharambe |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya |
OPD No. 14 Kaumarbhritya department, C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road, Chh.Sambhajinagar, 431011
Aurangabad
MAHARASHTRA |
9370123772
drprasadbharambe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Aurangabad |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashtamangal ghrita, Reference: Ashtang hridaya, uttar tantra, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Medicine will be administered to Both nostrils. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Siddharthak ghrita, Reference: Charak Samhita, Chikitsasthan 9, Verse 69-73, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Medicine will be administered to Both nostrils. |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children who fulfill the Diagnostic criteria of DSM 5 for Attention Deficit Hyperactivity Disorder.
2. Children aged between 6 to 12 years at the time of recruitment.
3. Participants will be selected irrespective of gender, religion, or socioeconomic background. |
|
| ExclusionCriteria |
| Details |
1. Children suffering from genetic syndromes or chromosomal abnormalities.
2. Nasya anarha.
3. Cases with schizophrenia, psychotic disorders, or significant neurodevelopmental comorbidities.
4. Children with significant sensory impairments, such as hearing or visual disabilities, that may interfere with assessment.
5. Children who are younger than 6 years or older than 12 years at the time of screening. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in severity of symptoms of Attention Deficit Hyperactivity Disorder |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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
|
Attention Deficit Hyperactivity Disorder ADHD is a neurodevelopmental disorder commonly seen in childhood and adolescence, characterized by inattention, hyperactivity, and impulsivity. These symptoms significantly affect academic performance, social behavior, and emotional development. The global prevalence of ADHD among school going children is estimated to be around 7.1 percent. Modern pharmacological treatments provide symptomatic relief but are associated with side effects such as appetite suppression, sleep disturbances, irritability, and growth related concerns. Therefore, there is a need for safe and effective alternative therapies.Gap identified, Rising burden of ADHD in children. Limitations and side effects of modern pharmacological treatment. Need for safe, sustainable, and holistic alternatives. Limited clinical evidence on Nasya therapy in ADHD. In Ayurveda, mental health is defined as the state of equilibrium of Dosha, Agni, Dhatu, and Mala along with a pleasant state of Atma, Indriya, and Mana. ADHD can be correlated with Manasika Vikara, particularly Unmada, which involves disturbances in Mana, Buddhi, Smriti, and behavior. Nasya Karma is described as an important Panchakarma procedure for diseases of Shirah, as the nose is considered the gateway to the brain. Siddhartaka Ghrita, mentioned in Charaka Samhita, is a Medhya, Vata Kapha Shamaka, and Shirovirechaka formulation that may help in improving cognitive and behavioral functions. The present study is planned as a randomized controlled clinical trial to evaluate the efficacy of Siddhartaka Ghrita Nasya in children aged 6 to 12 years diagnosed with ADHD. The trial group will receive Siddhartaka Ghrita Nasya, while the control group will receive Ashtamangal Ghrita Nasya. Assessment will be done at baseline, 30th, 60th, and 90th day using Vanderbilt ADHD Parent Rating Scale and SNAP IV scale. This study aims to generate clinical evidence regarding the role of Siddhartaka Ghrita Nasya in reducing ADHD symptoms and improving attention, behavior, and cognitive functions in children. |