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CTRI Number  CTRI/2024/05/067754 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 08/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   Muthu Parpam with Brahmi Nei (internal) and Siriya Bringamalaha Thailam (oil bath) for Attention Deficit Hyperactivity Disorder in Children. 
Scientific Title of Study   Clinical Evaluation of Siddha Management of Muthu Parpam with Brahmi Nei (internal) and Siriya Bringamalaha Thailam (oil bath) for Alathidu Sanni (Attention Deficit Hyperactivity Disorder) in Children. 
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 M Keerthana 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Department of Kuzhandhai Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai-600047

Kancheepuram
TAMIL NADU
600047
India 
Phone  8903771147  
Fax    
Email  keerthanamani.1968@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Vennila 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Department of Kuzhandhai Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai-600047

Kancheepuram
TAMIL NADU
600047
India 
Phone  9789093986  
Fax    
Email  gvennils@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Keerthana 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Department of Kuzhandhai Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai-600047

Kancheepuram
TAMIL NADU
600047
India 
Phone  8903771147  
Fax    
Email  keerthanamani.1968@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Ayothidoss Pandithar Hospital National Institute of siddha Tambaram Sanatorium Chennai-600047 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M Keerthana  Ayothidoss Pandithar Hospital  Out Patient Department No:16 Department of Kuzhandhai Maruthuvam Ayothidoss Pandithar Hospital National Institute of siddha Tambaram Sanatorium Chennai-600047
Kancheepuram
TAMIL NADU 		 08903771147

keerthanamani.1968@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee, National Institute of Siddha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F901||Attention-deficit hyperactivity disorder, predominantly hyperactive type,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Muthu Parpam With Brahmi Nei (internal) Siriya Bringamalaha Thailam (oilbath)  Internal-Bid after food Dose vary with age for 60 days External-Oil bath (4 days once) for 60 days 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Meets the diagnostic symptoms of (Any of the three or above)
1. Lack of concentration 2. Talking incessantly
3. Blurting things out 4. Frequent jumping from one task to another 5. Being easily distracted 6. Hyperactivity 7. Trouble sitting still 8. Inability to react to other people’s emotions or feelings.



 
 
ExclusionCriteria 
Details  1. H/O Seizure disorder
2. K/C/O Autistic spectrum disorder
3. Auditory and visual processing disorder.
4. Neurodegenerative disorder.
5. Post encephalitic disorder. 
 
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 Muthu Parpam & Brahmi Nei (internal) and Siriya Bringamalaha Thailam (oil bath) for the management of Alathidu Sanni (Attention Deficit Hyperactive Disorder) in children by using Conner’s investigator rating scale and conner’s parent rating scale.  Screening - 3 months
Patient Enrolment - 6 months
Trial Drug - 10 months
Data Analysis - 2 month
Follow up - 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/06/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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   INTRODUCTION: This is an open non randomized clinical trail to determine the effectiveness of Muthu Parpam with Brahmi nei (internal) and Siriya Bringamalaha Thailam (oil bath) for the management of Alathidu Sanni (Attention Deficit Hyperactive Disorder) in children. Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioral illness of childhood, one of the most prevalent chronic health issues impacting school-aged children. It is characterized by inattention, including increased distractibility and difficulty sustaining attention, poor impulse control and decreased self-inhibitory capacity and motor over activity and motor restlessness. Development of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria leading to the diagnosis of ADHD occurred mainly in field trials with children 5-12 years of age. The global prevalence of ADHD is 7.6% of children aged 3-12 years in which 33.2% of children are inattentive subtype, 30.3% are hyperactive impulsive subtype and 31.4% are combined type. MATERIALS AND METHODS: A total of 20 patients within age limit of 5-12 years willing to participate in the study by signing consent and assent form will be enrolled in the study. Both male and female children are included. RESULTS AND DISCUSSION: Effectiveness of the trial drug will be measured by reduction of clinical symptoms by using CONNERS PARENT RATING SCALE and the results will be statistically analysed. 
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