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CTRI Number  CTRI/2024/07/069890 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 02/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Role of Bodhi Satva Sukshma Aushadhi in increasing attention span of children affected with Attention Deficit Hyperactivity Disorder (ADHD). 
Scientific Title of Study   A randomised single blind placebo controlled comparative clinical study to evaluate the efficacy of Bodhi Satva Sukshma Aushadhi in the management of 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 Shubham Neelkanth Patil 
Designation  PG Scholar 
Affiliation  D.Y.Patil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai 
Address  OPD.No.7, 1st Floor, Department of Kaumarbhritya, Balroga division, D.Y.Patil School of Ayurveda, Sector 7, Nerul, Navi Mumbai

Mumbai
MAHARASHTRA
400706
India 
Phone  9022731817  
Fax    
Email  shubhamp181097@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kalpana Dattatray Dhuri 
Designation  Professor 
Affiliation  D.Y.Patil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai 
Address  D.Y.Patil Deemed to be University, School of Ayurveda, 3rd Floor, Department of Kaumarbhritya, Nerul, Sector 7, Navi Mumbai - 400706

Mumbai
MAHARASHTRA
400706
India 
Phone  9321835616  
Fax    
Email  kalpana.dhuri@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Kalpana Dattatray Dhuri 
Designation  Professor 
Affiliation  D.Y.Patil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai 
Address  D.Y.Patil Deemed to be University, School of Ayurveda, 3rd Floor, Department of Kaumarbhritya, Nerul, Sector 7, Navi Mumbai - 400706

Mumbai
MAHARASHTRA
400706
India 
Phone  9321835616  
Fax    
Email  kalpana.dhuri@dypatil.edu  
 
Source of Monetary or Material Support  
D.Y.Patil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai - 400706 
 
Primary Sponsor  
Name  D.Y.Patil Deemed to be University, School of Ayurveda 
Address  D.Y.Patil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai - 400706 
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 Shubham Neelkanth Patil  D.Y.Patil Ayurvedic Hospital, Navi Mumbai  OPD.NO.7, Department of Kaumarbhritya, Balroga
Mumbai
MAHARASHTRA 		 9022731817

shubhamp181097@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, D.Y.Patil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai  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
1Comparator Arm (Non Ayurveda)-PlaceboMedicine Name: Placebo, Route: Oral, Dosage Form: Lactose based pills, Dose: 100(mg), Frequency: tds, After meal, Duration: 60 Days
2Intervention ArmDrugOther than Classical(1) Medicine Name: Bodhi Satva Sukshma Aushadhi, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 100(mg), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: Bodhi Satva Sukshma Aushadhi is a newly developed oral formulation made from the leaf extract of the plant Ashwattha - Ficus religiosa also known as Peepal, Bodhi Vriksha and is not mentioned in any Classical Ayurvedic Texts.
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Children aged between 5-12 years of age
2. Children having signs and clinically diagnosed for Attention Deficit Hyperactivity Disorder ADHD as per DSM-5 Criteria. 
 
ExclusionCriteria 
Details  1. Children not fulfilling the DSM-5 Criteria for diagnosis of Attention Deficit Hyperactivity Disorder ADHD.
2. Known case of Cerebral palsy, mental retardation and epilepsy.
3. Known case of hearing deficit.
4. Children with obvious congenital anomalies like Cleft Palate, Coronary Heart Disease.
5. Known case of major systemic disorders and metabolic disorders. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduced DSM-5 Score  After every 15 Days (From 0th, 15th, 30th, 45th and 60th day). 
 
Secondary Outcome  
Outcome  TimePoints 
Reduced Inattention, Hyperactivity and Impulsivity  After every 15 Days (From 0th, 15th, 30th, 45th and 60th day). 
 
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 3 
Date of First Enrollment (India)   15/07/2024 
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="1"
Months="0"
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 the most common neurobehavioral disorder of childhood and can affect the academic achievement, well being and social interactions of the children. The recent COVID-19 pandemic along with quarantine, social isolation and increased screen time with the usage of smartphone for a longer period of time has disproportionately and adversely affected a generation of children with ADHD.

The objective of this study is to clinically evaluate the effectiveness of Bodhi Satva Sukshma Aushadhi in the management of Attention Deficit Hyperactivity Disorder in children. 60 patients from age 5-12 years fulfilling the DSM-5 criteria will be selected and enrolled for the study. Randomization of the selected patients will be done into two groups. Group A - 30 patients and Group B - 30 patients. Since this is a single blind study both groups will be given medicines in coded bottles. Group A will be orally administered with Bodhi Satva Sukshma Aushadhi for 60 days and Group B will be orally administered with Placebo pills for 60 days. Four consecutive follow ups will be taken in every 15 days and observations in DSM-5 scores will be recorded.  
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