| CTRI Number |
CTRI/2026/01/100711 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The Effect of Shatapushpa Churna in Children to improve ability to focus and concentration. |
|
Scientific Title of Study
|
A Single Arm Clinical Trial to Study the Effect of Shatapushpa Churna in Improving the Attention Span in Children of 6 to 13 Years of Age. |
| 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 Gautami Kashinath Nimase |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Kaumarbhritya SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
9049532304 |
| Fax |
|
| Email |
gautaminimase@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitesh Thakur |
| Designation |
Associate Professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Kaumarbhritya SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
8329041794 |
| Fax |
|
| Email |
thakurjiteshyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gautami Kashinath Nimase |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Kaumarbhritya SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
9049532304 |
| Fax |
|
| Email |
gautaminimase@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Gautami Kashinath Nimase |
| Address |
Department of Kaumarbhritya SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403 |
| 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 Gautami Kashinath Nimase |
SMBT Ayurved College and Hospital |
OPD No. 17 Department of Kaumarbhritya SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403
Nashik
MAHARASHTRA |
9049532304
gautaminimase@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Children of age group 6 to 13 years
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatapushpa Beeja (Anethum Sowa), Reference: Kaiyadeva Nighantu (Pathyapathyavibodhaka), Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: - Madhu (Honey)), Additional Information: - Age-wise dose:
1) 6–7 years: 2.0 g
2) 8–10 years: 2.5 g
3) 11–13 years: 3.0 g |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of age group 6 to 13 years.
2.Selection of Children is irrespective of their gender religion and socioeconomic status.
3.Parents who will give written consent for treatment.
|
|
| ExclusionCriteria |
| Details |
1.Mental retardation
2.Learning disability
3.Attention deficit hyperactivity disorder
4.Autism spectrum disorder
5.Gross developmental delay
6.Visual and auditory impairment
7.Chronic illness which hampers cognition in children
8.Severely malnourished children
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the Attention Span assessed with the help of PGI Memory Assessment Scale and Visual Cancellation Task. |
1.Total Duration of Treatment :- 30 Days
2.Assessment On Baseline and at Day 30.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 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
|
TITLE: A Single Arm Clinical Trial to Study the Effect of Shatapushpa Churna in Improving the Attention Span in Children of 6 to 13 Years of Age.
INTRODUCTION: Attention span is a key part of a child’s mental and cognitive development. In the present day academic environment, even healthy school-going children often struggle to concentrate for long periods. This affects their ability to learn, perform well in class, and manage their emotions effectively. In the past few years, many scientific theories have tried to explain how attention works, but there is no clear, universally accepted way to improve attention in normal children. Most available treatments are designed for children with conditions like ADHD and may not be suitable for healthy children. In Kashyapa Samhita, Shatapushpa (Anethum Sowa), has been mentioned for its role in enhancing Medha and Smriti. Shatapushpa (Anethum sowa) is a traditional Ayurvedic herb known for enhancing intellect (Medhya) and improving digestion (Agnideepana). A few studies say that it helps to improve IQ in children. Still, there is a lack of research on its specific effect on attention span in normal, healthy school children. To fill this gap, the current research has been planned to find out the effect of Shatapushpa Churna can improve attention span in children using standard psychological tests (PGI-Children memory scale and Visual Cancellation Task). This will help to confirm its use in improving attention span. Shatapushpa Beeja (Anethum Sowa) will be purchased from GMC certified pharmacy. Drug will be administered in Churna form for 30 days. All SOP of Churna Vidhi will be strictly followed during and after treatment. Assessment will be done on Day 0 and Day 30. Interim follow up at Day 15. SAMPLE SIZE: The sample size for the study will be 60 participants. Considering a 10% dropout rate, the total sample size will be 66 participants.
NULL HYPOTHESIS: (HO) Shatapushpa (Anethum Sowa) Churna does not improve the Attention Span in children of 6 to 13 years of age.
ALTERNATE HYPOTHESIS: (H1) Shatapushpa (Anethum Sowa) Churna improves the Attention Span in children of 6 to 13 years of age.
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