| CTRI Number |
CTRI/2022/10/046804 [Registered on: 26/10/2022] Trial Registered Prospectively |
| Last Modified On: |
21/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
In improving oral hygiene the effectiveness of black catechu powder for toothbrushing |
|
Scientific Title of Study
|
Effectiveness of Khadirachoorna for Dantadhavana in improving oral hygiene |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Linda A Stanly |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College Thiruvananthapuram |
| Address |
Department of Swasthavritta
Government Ayurveda Medical College Thiruvananthapuram
Kuzhinjattuvila veedu
Kulathoor
Uchakkada P O
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9495361619 |
| Fax |
|
| Email |
dr.lindashijulal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Linda A Stanly |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College Thiruvananthapuram |
| Address |
Department of Swasthavritta
Government Ayurveda Medical College Thiruvananthapuram
Kuzhinjattuvila veedu,Kulathoor, Uchakkada P O
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9495361619 |
| Fax |
|
| Email |
dr.lindashijulal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajitha Bhadran |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda Medical College Thiruvananthapuram |
| Address |
Department of Swasthavritta
Government Ayurveda Medical College Thiruvananthapuram
Bhadra,Mangattukadav
Thirumala Road
Perukaav P O
Thiruvananthapuram
Pin :695573
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9447452491 |
| Fax |
|
| Email |
sajithabhadran@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda Medical CollegeThiruvananthapuram |
| Address |
Linda A Stanly
MD Scholar
Department of Swasthavritta
Government Ayurveda Medical College Thiruvananthapuram |
| Type of Sponsor |
Other [Government Ayurveda Medical College Thiruvananthapuram] |
|
|
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 |
| Linda A Stanly |
Government Ayurveda Medical College Thiruvananthapuram |
OPD2 Department of Swasthavritta
Government Ayurveda Panchakarma Hospital Poojappura
Thiruvananthapuram
Thiruvananthapuram
KERALA |
9495361619
dr.lindashijulal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Government Ayurveda Medical College Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Svastha purusha |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Dantadhavana Pradhan Karma | (Procedure Reference: AshtangaHridayam and Ashtanga Sangraham Sutrasthana, Procedure details: One should brush their 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: Khadirachoorna, Reference: Ashtanga Hridayam Sutrasthana, 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 this study |
|
| ExclusionCriteria |
| Details |
1 Those who are having dental braces and artificial dentures
2 Those who are having active inflammatory conditions in the oral cavity like mouth ulcers,gingivitis etc
3 Known cases of severe systemic illness/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 |
0th &30th day |
|
|
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)
|
01/11/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
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. Amongst 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 Khadira in improving oral hygiene. The objective of the study is to find out the effectiveness of Khadirachoorna for dantadhavana in improving 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 Khadirachoorna 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 accordingly from the processed data by using appropriate statistical method |