| CTRI Number |
CTRI/2026/01/101680 [Registered on: 20/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Maternal Nutritional and Lifestyle Factors During Pregnancy on Childhood Attention Deficit Hyperactivity Disorder |
|
Scientific Title of Study
|
Maternal Diet and Lifestyle During Pregnancy and Risk of Attention Deficit Hyperactivity Disorder in offspring: A Case-Control Study |
| Trial Acronym |
ADHD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRACHI ATMARAM GAONKAR |
| Designation |
PG SCHOLAR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA, GOA |
| Address |
ALL INDIA INSTITUTE OF AYURVEDA,Pernem, Dhargal, North Goa
ALL INDIA INSTITUTE OF AYURVEDA,Pernem, Dhargal, North Goa
North Goa
GOA
403512
India |
| Phone |
8828189824 |
| Fax |
|
| Email |
dr.prachigaonkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHUTOSHKUMAR YADAV |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA, GOA |
| Address |
ALL INDIA INSTITUTE OF AYURVEDA, GOA
ALL INDIA INSTITUTE OF AYURVEDA, GOA
North Goa
GOA
403512
India |
| Phone |
7007931268 |
| Fax |
|
| Email |
ashutosh7475@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRACHI ATMARAM GAONKAR |
| Designation |
PG SCHOLAR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA, GOA |
| Address |
ALL INDIA INSTITUTE OF AYURVEDA, GOA
ALL INDIA INSTITUTE OF AYURVEDA, GOA
North Goa
GOA
403512
India |
| Phone |
8828189824 |
| Fax |
|
| Email |
dr.prachigaonkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Goa |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
ALL INDIA INSTITUTE OF AYURVEDA, DHARGAL,PERNEM,GOA, 403512 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| PRACHI ATMARAM GAONKAR |
ALL INDIA INSTITUTE OF AYURVEDA |
KAUMARBHRITYA OPD,BLOCK NO 4, OPD NO 46, ALL INDIA INSTITUTE OF AYURVEDA,DHARGAL, PERNEM,GOA, 403512
North Goa
GOA |
8828189824
dr.prachigaonkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F909||Attention-deficit hyperactivity disorder, unspecified type. Ayurveda Condition: UNMADA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Female |
| Details |
FOR CASE:
Children aged 2 TO 5 YEARS diagnosed with ADHD based on:
1.DSM-5 criteria
2.Clinical confirmation by a paediatrician or psychiatrist
Biological mothers who:
1.Had a singleton pregnancy
2.Are willing to participate and provide informed consent
3.Can recall and report dietary and lifestyle practices during pregnancy
FOR CONTROLS:
•Children aged 2 to 5 years with no diagnosis of ADHD or other neurodevelopmental disorders
•Matched to cases by age, gender and locality
•Biological mothers meeting the same criteria as above |
|
| ExclusionCriteria |
| Details |
For Both Groups:
Children with:
1.History of developmental delay, learning disability, ASD, major congenital anomalies.
2.History of premature birth less than 37 weeks or low birth weight less than 2.5kg
3.Severe sensory deficits (deaf/blind) or cerebral palsy.
4.Epilepsy with ongoing seizures
Mothers with:
1.Multiple pregnancies (twins/triplets)
2.Inability to recall pregnancy-related practices reliably
3.Refusal to provide informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Development of a Validated Ayurvedic-Based Questionnaire
2. Identification of Maternal Factors Associated with ADHD |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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="6"
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
|
Aim of the Study: To assess whether maternal diet and lifestyle during pregnancy influence the risk of ADHD in offspring. Study Design
Case–control study with two phases: 1)Development and validation of a structured maternal diet and lifestyle questionnaire.2)Comparison of questionnaire scores between ADHD cases and non-ADHD control Study Setting
Kaumarbhritya Department, All India Institute of Ayurveda, Goa. Study Population: Cases: Children aged 2–5 years diagnosed with ADHD by DSM-5 criteria and their biological mothers.Controls: Age- and gender-matched children without ADHD and their biological mothers. Sample Size: 30 cases and 30 controls (total 60 mother–child pairs). Data Analysis
Comparison of maternal exposure scores between ADHD and control groups using appropriate statistical tests, with correlation analysis to identify significant prenatal risk factors Expected Outcome: Identification of specific maternal dietary and lifestyle factors associated with ADHD and development of a validated Ayurvedic-based prenatal assessment tool.
|