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CTRI Number  CTRI/2024/05/067151 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 25/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of lakshadi taila shiropichu and jatamansyadi taila pratimarsha nasya in the management of attention deficit hyperactivity disorder in children. 
Scientific Title of Study   Evaluation of lakshadi taila shiropichu and jatamansyadi taila pratimarsha nasya in the management of attention deficit hyperactivity disorder in children-a randomised controlled clinical trial  
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 Mithila R Nadig 
Designation  PG Scholar 
Affiliation  KAHER Shri BMK Ayurveda Mahavidyalaya  
Address  Department of Kaumarabhritya KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003

Belgaum
KARNATAKA
590003
India 
Phone  9011293009  
Fax    
Email  mitnad12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aziz Arbar 
Designation  HOD & Professor 
Affiliation  KAHER Shri BMK Ayurveda Mahavidyalaya  
Address  Department of Kaumarabhritya KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003

Belgaum
KARNATAKA
590003
India 
Phone  9844532113  
Fax    
Email  azizarbar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aziz Arbar 
Designation  HOD & Professor 
Affiliation  KAHER Shri BMK Ayurveda Mahavidyalaya  
Address  Department of Kaumarabhritya KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003

Belgaum
KARNATAKA
590003
India 
Phone  9844532113  
Fax    
Email  azizarbar@gmail.com  
 
Source of Monetary or Material Support  
KLE Ayurveda Hospital Shahpur Belagavi 590003 
 
Primary Sponsor  
Name  KLE Ayurveda Hospital 
Address  KAHER Shri BMK Ayurveda Mahavidyalaya, Shahapur, Belagavi 590003 
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 Mithila R Nadig  KLE SHRI B.M.KANKANWADI AYURVEDA MAHAVIDYALAYA, BELGAVI KARNATAKA   ROOM NO 10 AND 11 DEPARTMENT OF KAUMARABHRITYA BELGAUM KARNATAKA
Belgaum
KARNATAKA 
09011293009

mitnad12@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Commitee for Research on Human Subjects  Approved 
Institutional Ethics Commitee for Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F078||Other personality and behavioral disorders due to known physiological condition. Ayurveda Condition: Unmadah,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Brahmi ghruta, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: -
2Intervention ArmProcedure-SiraHpicuH, शिरःपिचुः (Procedure Reference: Ashtanga Hrudaya , Procedure details: • Lakshadi taila is heated in a hot water bath. The temperature of the oil should be checked. It should be lukewarm. • Child is made to sit in a comfortable position on the chair. • Take a piece of cotton and make a thick pad out of it • Place the cotton bandage soaked in the medicated oil over the vertex of the head. • The Pichu is wrapped with the bandage material and tie cotton bandage around the head. • After the 30 minutes, remove the Shiropichu and bandage carefully. â€)
3Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtang Hrudaya , Procedure details: • The child is made to lie down in supine position • The head is slightly extended • The prescribed drops of medication are instilled in one nostril while the other one is closed • Repeat the same in the other nostril • Child is advised to be in resting position for 5 – 10 minutes )
(1) Medicine Name: Jatamansyadi taila , Reference: Sushrut Samhita, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 30 Days
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Children fulfilling the diagnostic criteria will be included for the study.

Children of either sex between the age group of 6-16 years.
 
 
ExclusionCriteria 
Details  Children with an acute or chronic, local or systemic infection will be excluded.

Children who are currently using other medications will be excluded owing to the possibility of drug interaction.

Known case of cerebral palsy, mental retardation, epilepsy and hearing defect etc.

Children with obvious congenital anomalies

Children who have received any form of modern intervention for ADHD in last 1 month
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
There might be an effect of Lakshadi taila Shiropichu and Jatamansyadi taila Pratimarsha Nasya in the management of ADHD in children which shall be assessed with Vanderbilt ADHD diagnostic parent rating scale  0th day,7th day,30th day 
 
Secondary Outcome  
Outcome  TimePoints 
There might be a significant effect of Lakshadi taila Shiropichu & Jatamansyadi taila Pratimarsha Nasya by the end of 30 days in children with ADHD which will be assessed by ADHD IMPACT MODULE-CHILD & Pediatric Quality of life Inventory   0th day,7th day,30th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   20/05/2024 
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 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  

NEED OF THE STUDY

ADHD is widely acknowledged as the most prevalent neurobehavioral and psychiatric disorder, significantly impacting the functional abilities of the children. The global prevalence of ADHD in children and adolescents is estimated to be around 5.29%, with a higher occurrence in males. In India, the prevalence varies between 2% to 17%. The World Health Organization (WHO) refers to ADHD as Hyperkinetic Disorder, and throughout an individual’s life, the symptoms and consequences of this condition can vary significantly. Children with ADHD generally struggle with inattentiveness, hyperactivity/ impulsivity which impacts on their academic skills, interpersonal relationships and social functioning. Family functioning is also highly affected by the child’s ADHD.  Recognition and management of ADHD in children is important so that their long-term outcomes can be improved.

In Modern Science, The preferred treatment for ADHD involves presynaptic dopaminergic agonists like Methylphenidate and Amphetamine , which are psychostimulant drugs. Adverse reactions are observed with these drug usage such as decreased appetite, irritability, tics, sleep issues, and an increased risk of adverse cardiovascular events. Prolonged use causes slowing of physical growth which is transient with an unclear cause. Consequently, there is an increasing need for an alternative treatment method.

In Ayurveda there are many drugs like Lakshadi taila, jatamansi, vacha , guduchi, durva, ashwagandha  etc that are known to be used in Manorogas and may be helpful in handling ADHD like conditions more effectively. Hence there is a growing need for an alternative treatment modality. Administering Lakshadi taila Shiropichu and Jatamansyadi taila Pratimarsha Nasya, by virtue of their karma may be helpful in the management of Attention deficit hyperactivity disorder in children.

 
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