| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 | | 2 | Comparator Arm | Drug | Classical | | (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. |