| CTRI Number |
CTRI/2021/11/038128 [Registered on: 18/11/2021] Trial Registered Prospectively |
| Last Modified On: |
18/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF EFFICIENCY OF POVIDONE IODINE, CHLORHEXIDINE AND HERBAL EXTRACT MOUTHWASH ON SARS-CoV-2 VIRAL LOAD IN SALIVA |
|
Scientific Title of Study
|
COMPARISON OF EFFICACY OF 2% POVIDONE IODINE, CHLORHEXIDINE AND HERBAL EXTRACT MOUTHWASH ON SARS-CoV-2 VIRAL LOAD IN SALIVA: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sayana Nazrine |
| Designation |
POST GRADUATE |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Room no 4,Department of Periodontology,Rajarajeswari Dental college and Hospital, No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Rajarajeswari Dental college and Hospital, No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
09945038228 |
| Fax |
|
| Email |
sayananazrine12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivaprasad BM |
| Designation |
PROFESSOR |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Room no 4,Department of Periodontology,Rajarajeswari Dental college and Hospital, No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Room no 4,Department of Periodontology,Rajarajeswari Dental college and Hospital, No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
09945038228 |
| Fax |
|
| Email |
drspbmath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivaprasad BM |
| Designation |
PROFESSOR |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Room no 4,Department of Periodontology,Rajarajeswari Dental college and Hospital, No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Room no 4,Department of Periodontology,Rajarajeswari Dental college and Hospital, No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
09945038228 |
| Fax |
|
| Email |
drspbmath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Sayana Nazrine |
| Address |
Rajarajeswari Dental college and Hospital |
| 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 Sayana Nazrine |
Rajarajeswari Dental College and Hospital |
Room no 4,Department of Periodontology,Rajarajeswari Dental college and Hospital, No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore
KARNATAKA |
09945038228
sayananazrine12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Rajarajeswari dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COMPARISON OF EFFICACY OF 2% POVIDONE IODINE, CHLORHEXIDINE GLUCONATE AND HERBAL EXTRACT MOUTHWASH ON SARS-CoV-2 VIRAL LOAD IN SALIVA |
Baseline throat/saliva sample collection for Covid positive patients. Intervention is done using the specified mouthwash.A waiting period of 30 minutes,followed by 2nd saliva/throat sample collection. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients who have tested positive for SARS-CoV-2 virus.
2)Patients who are symptomatic and asymptomatic.
3)Willingness to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1)With history of iodine hypersensitivity.
2)Patients with hypersensitivity towards Asparagus racemosus, Glycyrrhiza glabra and Rosmarinus officinalis.
3)Patients with chlorhexidine gluconate hypersensitivity.
4)Patients with thyroid diseases.
5)Children
6)Pregnant females
7)Breast feeding mothers
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Ct (cyclic threshold) values will be assessed with the baseline sample and 30 minutes sample. |
Baseline,3 months |
|
|
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)
|
31/12/2021 |
| 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="0"
Months="3"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sayananazrine12@gmail.com].
- For how long will this data be available start date provided 27-10-2021 and end date provided 01-02-2022?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The aim and purpose of this study is to understand the efficacy of povidone iodine, chlorhexidine and herbal mouthwash on SARS-C0V-2 virus. Previously various studies have been conducted on MERS and SARS-CoV-1 virus and these mouthwashes have been proven to reduce the viral load. Similarly various pilot studies and in vitro studies have proven their efficiency against the same. Hence this study aims at understanding the ability of these mouthwashes in reducing the Ct(cyclic threshold) values and how they can be useful in a clinical setup in order to reduce the viral load especially in aerosols.
Citation for a pilot study is added:MartÃnez Lamas L, Diz Dios P, Pérez RodrÃguez MT, Del Campo Pérez V, Cabrera Alvargonzalez JJ, López DomÃnguez AM, Fernandez Feijoo J, Diniz Freitas M, Limeres Posse J. Is povidone iodine mouthwash effective against SARS-CoV-2? First in vivo tests. Oral Dis. 2020 Jul 2:10.1111/odi.13526. doi: 10.1111/odi.13526. Epub ahead of print. PMID: 32615642; PMCID: PMC7362147. |