| CTRI Number |
CTRI/2026/01/100311 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Screening
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Banadi Oil for Better Oral Hygiene in Childrens |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of banadi oil to maintain the oral hygiene in pediatric age group |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dipesh Raj |
| Designation |
pg scholar |
| Affiliation |
shri narayan prasad awasthi government ayurved college raipur C.G. |
| Address |
Department Of Kaumarabhritya OPD NO.10 & IPD Patients Shri
Khudadad Doongaji Government Ayurved Hospital Raipur
Chhattisgarh 492010
Raipur
CHHATTISGARH
Raipur
CHHATTISGARH
492010
India |
| Phone |
9754629437 |
| Fax |
|
| Email |
dipeshrajm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Neeraj Agrawal |
| Designation |
Professor and HOD |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur |
| Address |
Department Of Kaumarbhritya Shri Narayana Prasad Awasthi
Government Ayurved College
Raipur
Raipur
CHHATTISGARH
492010
India |
| Phone |
9109923485 |
| Fax |
|
| Email |
dr_neeraj2001in@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadhana Jaiswal |
| Designation |
M. Sc, Ph.D. (Microbiology) Assistant Professor and HOD Dept. of Microbiology |
| Affiliation |
Govt. Nagarjuna PG college of science, Raipur (C.G.) |
| Address |
Govt. Nagarjuna PG college of science, Raipur (C.G.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9826487294 |
| Fax |
|
| Email |
Sadhna_jaiswal74@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Kaumarbhritya Shri Narayan Prasad Government Ayurved College Raipur |
|
|
Primary Sponsor
|
| Name |
Department Of Kaumarbhritya Shri Narayan Prasad Government Ayurved College Raipur |
| Address |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur
Chhhattisgarh 492010 |
| Type of Sponsor |
Other [Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhhattisgarh 492010] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shri Narayan Prasad Awasthi Government Ayurved College Raipur |
Shri Narayan Prasad Awasthi Government
Ayurved College Raipur Chhhattisgarh 492010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr dipesh raj |
Shri Khudadad Doongaji Government Ayurved Hospital Raipur Chhattisgarh |
OPD No.10 and IPD
department Of
Kaumarbhritya Shri
Khudadad Doongaji
Government Ayurved
Hospital Raipur
Chhattisgarh 492010
Raipur
CHHATTISGARH
Raipur
CHHATTISGARH |
9754629437
dipeshrajm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee government ayurved college raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy children age 2-5 yr with having halitosis and plaque |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: BANADI TAILA , Reference: ASTANG HRIDAYA UTTARSTHAN 22/88-89, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
children with complaints of halitosis(bad breath) and plaque
willing and able to participate for the study duration
parenta guardian informed and written consent obtained
willing to follow study instruction |
|
| ExclusionCriteria |
| Details |
children below 2 year and above 5 years
children with underlying and oral disease systemic diseases
children with antibiotic use history in the last 15 days |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in oral hygiene status bacterial count and oral hygiene index from baseline to post treatment after intervention period |
intervention given for 14 days post treatment follow up on 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the in-vitro antimicrobial effect of banadi taila.
bacterial count and oral hygiene index from baseline to post treatment after intervention period |
intervention given for 14 days post treatment follow up on 15th day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/02/2026 |
| 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="2"
Days="10" |
|
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
|
Poor oral hygiene can significantly affect general health, and several oral diseases are associated with chronic systemic conditions. In modern lifestyles, excessive consumption of fast food, carbonated beverages, spicy foods, and the use of substances such as ice cream, chocolate categorized in Ayurveda as apathyakar (unwholesome)—disturb the normal flora of mouth and gut contribute to the development of oral diseases. These conditions often manifest as redness, ulcerations in the oral cavity, burning sensations, and pain.
Any disruption in the natural balance of oral flora may indicate underlying systemic or local diseases. The ancient Ayurvedic texts highlight procedures such as Dantadhavan (brushing of teeth), Jivha Nirlekhan (tongue scraping), and Gandush (oil or decoction holding in the mouth) as essential components of Dinacharya (daily regimen) to maintain oral hygiene.
This clinical study aims to evaluate the efficacy of Banadi Taila Pratisaran (local oil application) in maintaining oral hygiene among children aged 2 to 5 years. Poor oral hygiene in early childhood can lead to plaque formation, halitosis, and systemic infections. Banadi Taila, a classical Ayurvedic formulation described in Ashtanga Hridaya (Uttara Sthana 22/88–89), contains herbs such as Barleria strigosa, Khadira, Jambu, Mulethi, Anantmool, Irimed, Amra, Neelkamal, and Til taila, which are known for their antimicrobial and Kapha-Pitta shamaka properties.
The study follows a non-randomized, open-label, single-arm, prospective interventional design with 50 pediatric subjects. Each participant will receive Banadi Taila Pratisaran twice daily for 14 days. Assessment will include both subjective parameters (appetite and halitosis) and objective parameters (oral flora bacteriological count and Oral Hygiene Index–Simplified).
Statistical analysis will be done using the Wilcoxon test for subjective and paired t-test for objective parameters. The expected outcome is a significant reduction in bacterial count and plaque index, validating Banadi Taila as a safe, effective, and traditional Ayurvedic method for maintaining oral hygiene and preventing oral diseases in children. |