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CTRI Number  CTRI/2026/02/103412 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 08/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the efficacy of Padamardana with Mastu and Shatadhauta ghrita in children with ADHD. 
Scientific Title of Study   Randomized open-label clinical study on the efficacy of padamardana with mastu in comparison to padamardana with shatadhauta ghrita in anidra in children with ADHD. 
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 D Shri Gayathri 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic science and Research, Bangalore 
Address  Room no-9, kaumarabhritya OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura. Bangalore

Bangalore Rural
KARNATAKA
560082
India 
Phone  9790267976  
Fax    
Email  vdshrigayathri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Divyasri R A 
Designation  Professor 
Affiliation  Sri Sri College of Ayurvedic science and Research, Bangalore 
Address  Room no-9, kaumarabhritya OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura. Bangalore

Bangalore Rural
KARNATAKA
560082
India 
Phone  9448939421  
Fax    
Email  divya_mesha@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Divyasri R A 
Designation  Professor 
Affiliation  Sri Sri College of Ayurvedic science and Research, Bangalore 
Address  Room no-9, kaumarabhritya OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura. Bangalore


KARNATAKA
560082
India 
Phone  9448939421  
Fax    
Email  divya_mesha@yahoo.co.in  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore, Karnataka - 560082 India 
 
Primary Sponsor  
Name  Dr D Shri Gayathri 
Address  Sri Sri College of Ayurvedic science and Research Hospital, Bangalore. 
Type of Sponsor  Other [SELF] 
 
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 D Shri Gayathri  Sri Sri College of Ayurvedic science and Research Hospital, Bangalore.  Room no-9, Kaumarabhritya OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura. Bangalore KARNATAKA
Bangalore Rural
KARNATAKA 
9790267976

vdshrigayathri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F510||Insomnia not due to a substance orknown physiological condition. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shatadhauta ghrita, Reference: Charaka Samhita Sutra Sthan, Route: Topical, Dosage Form: Ghrita, Dose: 20(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: --External/ topical application over foot before sleep
2Comparator ArmDrugClassical(1) Medicine Name: Dadhi mastu, Reference: Bhavaprakasha Nighantu, Route: Topical, Dosage Form: Mantha, Dose: 100(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: --External/ topical application over foot before sleep
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Participants with ADHD having Mild-Moderate Insomnia as per diagnostic criteria
will be included.

Participants with ADHD showing classical signs of Nidranasha (loss of sleep) will
be included.

Participants whose parents are willing to sign the consent form, and children who give verbal assent will be included.  
 
ExclusionCriteria 
Details  Children with ASD will be excluded.

Children with ADHD taking long term oral medications for Insomnia will be
excluded.

Children with ADHD who have severe Insomnia will be excluded.

Children with other systematic illness like Juvenile Diabetes, Thyroid disorders will
be excluded.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant reduction in Insomnia in children with ADHD assessed with Sleep Disturbance Scale for Children.  0 - 21 - 30 - 45th day 
 
Secondary Outcome  
Outcome  TimePoints 
1. Generation of in – depth analysed data on the different aspects of the disease.

2. Generation of data on probable mode of action of drug.

3. Improvement in academic performance and attention span based on parent or teacher feedback.

4. Reduction in hyperactivity often seen associated with insomnia in children with ADHD.
 
1 year 
 
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 3 
Date of First Enrollment (India)   20/02/2026 
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="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  
Sleep plays a vital role in the cognitive emotional and physical development of children and is essential for their overall growth and future contribution to society. Insomnia is a common yet underdiagnosed sleep disorder in the pediatric population and its prevalence is increasing due to lifestyle changes. It is characterized by difficulty in initiating or maintaining sleep leading to reduced total sleep duration. Sleep disturbances are frequently seen in children with Attention Deficit Hyperactivity Disorder and tend to worsen core symptoms such as inattention, hyperactivity, impulsivity, cognitive deficits and emotional dysregulation. Insomnia in these children also affects academic performance quality of life and significantly impacts parental mental health by increasing stress anxiety and fatigue.

Conventional management includes sleep hygiene measures and cognitive behavioral therapy but many children do not respond adequately to pharmacological interventions such as melatonin or sedatives leading parents to seek alternative approaches. In Ayurveda insomnia can be correlated to Anidra or Nidranasha which is associated with imbalance of Vata dosha disturbances of Manovaha srotas and predominance of Rajasika satwa. Children with ADHD are more prone to such sleep disturbances.

Ayurveda offers several therapeutic measures including lifestyle regulation Panchakarma procedures and psychological interventions to improve sleep. Among these Padamardana is a simple cost effective and well accepted therapy described in classical texts as sleep inducing. Padamardana with Mastu helps in Vata shamana and reduces fatigue while Shatadhauta ghrita promotes relaxation and pacifies Vata and Pitta. Modern evidence also supports the role of foot massage and reflexology in improving sleep quality through neurohormonal regulation.

Despite classical references and wide acceptability there is a lack of scientific studies standardizing Padamardana and evaluating its efficacy in children with ADHD related insomnia. Hence the present study is designed to assess the effectiveness of Padamardana with Mastu and Shatadhauta ghrita in the management of Anidra in children with Attention Deficit Hyperactivity Disorder.
 
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