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CTRI Number  CTRI/2024/06/068680 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 08/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Assessing a New Treatment Approach for ADHD: Combining Herbal Syrup with Relaxation Techniques like shirodhara and shiropichu. 
Scientific Title of Study   A Single Arm Open Label Clinical Trial To Evaluate The Efficacy Of Combined Therapy - Brahmyadi Syrup With Shirodhara And Shiropichu In The Management Of 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. Suman rulaniya  
Designation  Pg scholar  
Affiliation  NATIONAL INSTITUTE OF AYURVEDA JAIPUR RAJASTHAN  
Address  Department of kaumarbhritya National institute of ayurveda jaipur rajasthan 302002

Nagaur
RAJASTHAN
302002
India 
Phone  7357871373  
Fax    
Email  sumanrulaniya97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rakesh nagar 
Designation  Associate professor department of kaumarbhritya National institute of ayurveda  
Affiliation  National institute of ayurveda jorawar singh gate jaipur  
Address  Chamber no 227 Department of kaumarbhritya national institute of ayurveda jorawar singh gate jaipur rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9414062099  
Fax    
Email  drrknagar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishal prajapati  
Designation  Assistant professor national institute of ayurveda jaipur 
Affiliation  National institute of ayurveda jorawar singh gate jaipur  
Address  Chamber no 230 Department of kaumarbhritya national institute of ayurveda jorawar singh gate jaipur rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  8169436681  
Fax    
Email  Vish123go@gmail.com  
 
Source of Monetary or Material Support  
National institute of ayurveda jorawar singh gate madhav villas amber road jaipur rajasthan india 302002 
 
Primary Sponsor  
Name  National institute of ayurveda jaipur  
Address  National institute of ayurveda jorwar singh gate jaipur rajasthan 302002 
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 Suman rulaniya   National institute of ayurveda   Opd no 5 department of kaumarbhritya madhav villas Jorawar singh gate amber road jaipur
Jaipur
RAJASTHAN 
7357871373

Sumanrulaniya97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee national institute of ayurveda deemed university jaipur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mUrdhatailam/ Sirastailam, मूर्धतैलम्/ शिरस्तैलम् (Procedure Reference: Bhavprakash nighantu, Procedure details: Shirodhara with dashmoola sidh ksheer for 15 days )
(1) Medicine Name: Dashmoola sidh ksheer, Reference: Bhavprakash , Route: Topical, Dosage Form: Ksheerpaka, Dose: 1000(ml), Frequency: od, Duration: 15 Days
2Intervention ArmProcedure-mUrdhatailam/ Sirastailam, मूर्धतैलम्/ शिरस्तैलम् (Procedure Reference: Bhavprakash nighantu, Procedure details: Shiropichu with jyotishmati oil for 75 days )
(1) Medicine Name: Jyotishmati taila, Reference: Bhavprakash nighantu, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 75 Days
3Intervention ArmDrugClassical(1) Medicine Name: Bramhyadi syrup, Reference: Bhaisajya ratnawali 24/5, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children of either sex in between age group of 5 to 10 years.
Diagnosed case of ADHD.
Children with average/normal IQ level (more than 90)
Subjects satisfying DSM-5 criteria of diagnosis
 
 
ExclusionCriteria 
Details  Children with any known psychiatric illness and neurological disorder.
Children with gross brain damage causing mental retardation
Children with any genetic disorder
Children with gross physical disability
Children with any associated long term or fatal disease.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in the scoring/grading of symptom of ADHD on NICHQ Vanderbilt Assessment scale.  Every 2 week of clinical trial.
After 16 week of clinical trial completion.  
 
Secondary Outcome  
Outcome  TimePoints 
Change in the quality of life by improvement in cognition & concentration with safe & effective treatment.  Every 2 week of clinical trial.
After 16 week of clinical trial completion.  
 
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 
Date of First Enrollment (India)   20/07/2024 
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="0"
Months="5"
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  

Modern ADHD treatment have significant drawback including the potential to have a serious negative influence on a child’s entire development. Ayurveda is holding numerous ways to diagnose and manage various diseases. Although several studies have been conducted and some remain are on-going on this disease but still any specific precise management and strategy not have been established, thus much more research must be done in order to achieve this goal in future. Due to their low socioeconomic level many parents in developing nations like India unable to afford the different therapies required for ADHD. Therefore, careful research is needed to discover more affordable, accessible and palatable medications for such disease. BrahmyadiYoga is mentioned in BhaisajyaRatnavali text book, Unmadrogaadhikaar Chapter Number 24 as a Unmadaharayog.Till now, as per scholars’ knowledge there is no research work available on this drug for ADHD in children. It contains drugs like Brahmi, Vacha, Shankhpushpi, Kushmaand, Kustha which are considered as Medhya (~nootropic) drugs according to Acharya Priyavart Sharma.Active ingredients of these drugs acts on brain function which may also be beneficial in improving the symptoms of ADHD. Also, these drugs are easily available and cost effective. To improve the palatability and compliance of drug, Brahmyadiyoga will be modified as a Syrup form. Bacosides active ingredients of Brahmi responsible for improving memory related disorders, and enhance efficiency of transmission of nerve impulse there by strengthening memory and cognition.Shankhpushpi has a calming effect by regulating the body’s production of the stress hormones, adrenaline and cortisol. The bioactive components of Convolvulus pluricaulis are Sitosterol glycoside, octacosanoltetracosane, hydroxycinnamic acid, and glucose. These metabolites contribute to its nootropic and memory enhancing properties, along with its other pharmacological activities. Rhizome of Vacha has been reported to possess tranquilizing, neuroprotective, anti-cholinesterase, anticonvulsant activity.Certain research works done on Kushmanda have yielded beneficial effects on mental health. Kushmanda considers best for promotion of longevity, promotion of memory and intellect Kustha have Hypotensive and vaso relaxation effect, CNS depressant effect, immune-modulator.

Shirodhara is a method whereby pouring any liquid or medicated liquid(milk/oil/buttermilk)  over the forehead of the patient in the form of a regular stream from a particular height (precisely 3.14 inches (as mentioned in Dharakalpa of Sahasrayogam) in the form of oscillatory movements for 30-45 minutes. Mind and higher consciousness is affected in disease like ADHD. And these can be considered under broad term Unmada in Ayurveda. For providing an tranquilizing effect and increasing attention, Shirodhara is the well-known treatment modality. Shiropichu is procedure of applying the oil to the vertex using cotton pad impregnated with oil. It is found to be more beneficial in neuropsychiatric disorders. Because of its easy applicability along with added effect of all Moordhinitaila these considred as important procedure in ADHD.

 
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