| CTRI Number |
CTRI/2025/02/080527 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Antibacterial study of Ayurvedic Toothpaste |
|
Scientific Title of Study
|
Antibacterial study of Ayurveda Based toothpaste for Dantadhavana in Dinacharya |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandeesh J K |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan |
| Address |
Department of Swasthavritta
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan
B M Road,Thanniruhalla-573201
Department of Swasthavritta
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan
B M Road,Thanniruhalla-573201
Hassan
KARNATAKA
573201
India |
| Phone |
08217525920 |
| Fax |
|
| Email |
nandeeshjk88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.M B Kavita |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan |
| Address |
Department Of Swasthavritta
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan
Department Of Swasthavritta
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9480161042 |
| Fax |
|
| Email |
drmbkavita@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Nandeesh J K |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan |
| Address |
Department Of Swasthavritta
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan
Department Of Swasthavritta
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
08217525920 |
| Fax |
|
| Email |
nandeeshjk88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan
thanniruhalla-573201 |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan
B M Road,Thanniruhalla-573201 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and HospitalHassan |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan
B M Road,Thanniruhalla-573201 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nandeesh J K |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan |
Department of Swastavritta
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan-573201
B M Road,Thanniruhalla-573201
Hassan
KARNATAKA |
8217525920
nandeeshjk88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Individual without dental deformity |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ayurveda Based Toothpaste, Reference: NA, Route: Oral, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 2(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject aged between 20 to 60 years, irrespective of gender
2.Subject who are not known case of oral disease
3.subject who is ready to give written consent |
|
| ExclusionCriteria |
| Details |
1)Known case of Any structural deformities of oral cavity.
2)Known case of Stomatitis
3)Known case of Gingival recession
4)Known case of Bleeding gum
5)Known case of Periodontal diseases
6)Known case of Oral cancer
7)Known case of Oral thrush
8)Known case of Subjects with Artificial denture
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate efficacy of ayurveda based Toothpaste
by conducting Bacteriological study through serial diluation and pour plate method |
within 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study anti-bacterial activity of ayurveda based toothpaste through bacteriological study by serial dilution & pour plate method |
within 4 weeks |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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
|
The study title is "Antibacterial study of Ayurveda Based Toothpaste for Dantadhavana in Dinacharya". This is Purposive sampling Interventional study. This study has been taken to evaluate Anti-bacterial study of ayurveda based toothpaste on the age group between 20 to 60 years who will visit SDM college of Ayurveda and Hospital,Hassan with a sample size of 30 and study duration will be of 1 year 6 months. the data will be collected bt CRF and questionnarie method and questions are validated that are being used in the study and data analysis will be done with help of SPSS software |