| CTRI Number |
CTRI/2023/10/059149 [Registered on: 26/10/2023] Trial Registered Prospectively |
| Last Modified On: |
14/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
In Oral Hygiene The Effectiveness of Lebbeck powder for Tooth Brushing |
|
Scientific Title of Study
|
Effectiveness Of Sirisha Choorna For Dantadhavana In Oral Hygiene |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANDEEP KRISHNAN |
| Designation |
Pg Scholar |
| Affiliation |
Government Ayurveda Medical College Thiruvananthapuram |
| Address |
Department Of Swasthavritta
OP Number 2
Govt Ayurveda Medical College
Thiruvananthapuram
Department Of Swasthavritta
OP Number 2
Govt Ayurveda Medical College
Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9895283272 |
| Fax |
|
| Email |
sandeepkrishnan2255@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SANDEEP KRISHNAN |
| Designation |
Pg Scholar |
| Affiliation |
Government Ayurveda Medical College Thiruvananthapuram |
| Address |
Department Of Swasthavritta
OP Number 2
Govt Ayurveda Medical College
Thiruvananthapuram
Department Of Swasthavritta
OP Number 2
Govt Ayurveda Medical College
Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9895283272 |
| Fax |
|
| Email |
sandeepkrishnan2255@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayan D |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda Medical College Tripunithura |
| Address |
Department of Swasthavritta
Government Ayurveda Medical College
Tripunithura
Department of Swasthavritta
Government Ayurveda Medical College
Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
9447104383 |
| Fax |
|
| Email |
dr.jayan.d@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda Medical College Thiruvananthapuram |
| Address |
Sandeep Krishnan
MD Scholar
Department of Swasthavritta
Government Ayurveda Medical College Thiruvananthapuram |
| Type of Sponsor |
Government medical college |
|
|
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 Sandeep Krishnan |
Government Ayurveda Medical College Thiruvananthapuram |
OPD 2
Department of Swasthavritta
Government Ayurveda Panchakarma Hospital Poojappura Thiruvananthapuram
Thiruvananthapuram
KERALA |
9895283272
sandeepkrishnan2255@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instititutional Ethical Committee Government Ayurveda College Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Swasthapurusha |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Dantadhavana | (Procedure Reference: Ashtanga Hridayam sutrasthanam, Procedure details: One should brush the teeth morning and night after intake of food.lower row of teeth should be brushed first.one should be careful while brushing and not to make any injuries to gums.)
(1) Medicine Name: Sirisha choorna, Reference: Bhavaprakasha Purvakhanda , Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants aged between 25 to 55 years
2.All sexes
3.Those who are willing to participate in study |
|
| ExclusionCriteria |
| Details |
1.Those who are having dental braces and artificial demtures
2.Those who are having active inflammatory conditions in the oral cavity
3.Known case of severe systemic illness or malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Oral Hygiene Index and Oral Microflora |
Change in Oral Hygiene Index and Oral Microflora after 4 weeks(1 month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
01/11/2023 |
| 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 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
|
Ayurveda is considered as a holistic medical branch and the health is achieved by some preventive procedures such as Dinacharya,Nishacharya and Ritucharya.Among Dinacharya, Dantadhavana is a unique concept to maintain oral hygiene. Oral hygiene is the aspect of dental care which includes all the oral cleansing processes for keeping mouth clean and healthy. A large number of people in India suffers from periodontal diseases usually the result of poor oral hygiene. The goal of oral hygiene is to prevent the formation and build-up of plaques and tartar, to prevent dental caries and periodontal disease, and to decrease the incidence of halitosis. Ayurveda had introduced various procedures for maintaining oral health such as dantadhavana(brushing), jihwalekhana(cleaning tongue),kavala and gandusha. Different herbs have been mentioned in Ayurveda for dantadhavana. The present study is for evaluating the effect of Sirisha choorna in oral hygiene.
The objective of the study is to find out the Effectiveness of Sirisha choorna for Dantadhavana in Oral Hygiene.A sample size of 30 individuals from all sexes aged between 25 to 55 years will be selected from OPD of Dept.of Swasthavritta,Govt Ayurveda Panchakarma Hospital ,Poojappura, Thiruvananthapuram .All the subjects participating in the study will be advised for brushing the teeth with Sirisha choorna for a period of 30 days twice daily. The oral hygiene index and microbiological examination of saliva will be assessed before and after the study. Data will be collected,processed and conclusion will be made accordinaly from the processed data by using appropriate statistical methods. |