Covid-19GARGLESNCT04341688
A Clinical Trial of Gargling Agents in Reducing Intraoral Viral Load Among COVID-19 Patients
A study testing Gargle/Mouthwash in people with Covid-19, run by Aga Khan University.
Trial summary
Pakistan is a resource restraint country, it's not possible to carry out coronavirus testing at mass scale. Simple cost effective intervention against the present pandemic is highly desirable. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid-19
- What is being tested?
- Gargle/Mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria are laboratory confirmed Covid-19 positive male or female subjects in the age range of 18-65 years, within seven days of the onset of mild to moderate symptoms of viral infection, already admitted in the hospital.
Who cannot join
- Edentulous patients, patients with low Glasgow coma score, intubated, immune-compromised, history of radiotherapy or chemotherapy will be excluded. Patients with known pre-existing chronic mucosal lesions such as lichen planus will also be excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Double Blind, Randomized Controlled Pilot Trial of Gargling Agents in Reducing Intraoral Viral Load Among Laboratory Confirmed COVID-19 Patients: GARGLES STUDY
Pakistan is a resource restraint country, it's not possible to carry out coronavirus testing at mass scale. Simple cost effective intervention against the present pandemic is highly desirable.
For patients: Identifying an antiviral gargle that could substantially reduce the colonies of COVID-19 residing in mouth and oro-naso-pharynx is likely to reduce the viral load. Such reduction in the viral load through surface debridement could aid the effective immune response in improving the overall symptoms of the patients.
Read more
For dentists: This study is important because the nature of the dental profession involves aerosol production, carrying out dental work on asymptomatic patients carrying coronavirus puts the entire dental team at a great risk of not only acquiring the infection but also transmitting it to the others. Antiviral gargles could be used by dentist and their auxiliaries as prophylaxis.
For physicians and nurses: The risk of morbidity and mortality is high among physicians and nurses involved in the screening and management of Covid-19 patients. Globally, over 215 physicians and surgeons have died while taking care of Covid-19 patients. The cause of death is attributed to high exposure of viral load. The antiviral gargles and nasal lavage can decrease the fatalities among doctors and nurses.
Thus, patients, physicians, nurses and dentists, all could be benefited with this findings of this study.
Read the detailed description
It will be a parallel group, quadruple blind-randomized controlled pilot trial annexed with a laboratory based study. Clinical trial will be carried out at the Aga Khan University Hospital (AKUH), Karachi, Pakistan. Patients will be inducted from the pool of known patients (laboratory confirmed COVID-19 participants) within 7 days of the onset of viral infection symptoms, already admitted at AKUH. Molecular and immunological testing will be done at the Juma laboratory of AKUH. The intervention drugs (Povidone-Iodine, Hydrogen Peroxide and Hypertonic Saline will be obtained from the AKUH distribution department and/ or AKUH pharmacy. The Neem extract will be compounded at the Chemistry department, University of Karachi/ HEJ institute of Organic Chemistry, University of Karachi.
We will need 50 patients. There will be five study groups. Group A (n=10) patients on 10 ml gargle and nasal lavage with of 0.2% Povidone-Iodine for 20-30 seconds, twice daily for 5 days. Group B (n=10) patients will be subjected to 10 ml gargle and nasal lavage with 1% Hydrogen peroxide for 20-30 seconds, twice daily for 5 days. Group C will comprise of (n=10) subjects using 10ml gargle and nasal lavage with Neem extract (Azardirachta indica) for 20-30 seconds, twice daily for 5 days. Group D (n=10) patients will use 2% hypertonic saline gargle and nasal lavage for a similar time period. Group E (n=10) will serve as positive controls. These will be given simple distilled water gargles and nasal lavage for 20-30 seconds, thrice daily for six days. For nasal lavage, a special douche syringe will be provided to each participant. Its use will be thoroughly explained by the data collection officer.
Data collection: The baseline oral swab will be taken from the posterior pharyngeal wall/ tonsillar area on day one before initiating the gargles by trained dentist. The end-point oral swab will be taken on day 7, just after using the prescribed gargle. Patient will be provided with a special hood so that they themselves don't generate aerosol in the immediate vicinity while carrying out the gargling and nasal lavage.
Data will be analyzed using SPSS for Windows (version 23.0 SPSS) and Graph Pad Prism 7.0 software.
Mean and standard deviation of the continuous variables (age, COVID-19 viral counts and cytokine profiles at baseline and endpoint etc.) will be computed. Frequency distribution of the categorical variables will be determined (gender, co-morbids, presence of hypertension, diabetes, periodontal status etc.) Repeated measures ANOVA will be used to compare the reduction in intra-oral viral load and the changes in the inflammatory biomarkers in the study groups. In case of substantially low count of participants in the study groups, non-parametric tests such as Kruskal-Wallis or Friedman test will be employed. Multiple linear regression (MLR) will done to predict changes in the Covid-19 viral load and cytokine profiles. A subset analysis using Zero inflated negative binomial (ZINB) model will be employed, provided a significant reduction in viral load is observed in any of the study groups. A p-value of <0.05 will be taken as statistically significant. {20a}
The biases and confounders can be taken care at following four levels:
At recruitment stage, we will use restriction i.e. only those COVID positive subjects will be recruited who have no other major co-morbidities. At intervention assignment, the random group allocation will ensure even distribution of the confounders in the study groups thus their differential effect on the outcome will be addressed. At analysis, we will employ regression analysis (as described above) to account for biases and confounders and lastly, the subset analysis will stratify the data and nullify the effect of biases.
Interim analysis {20b} is not planned on account of a short duration of the study. Missing data/ uncompliant patients {20c} will be omitted from the final analysis.
- Conditions
- Covid-19
- Being tested
- Gargle/Mouthwash
- Keywords
- Covid-19;, coronavirus disease, povidone, hydrogen peroxide, neem extracts, topical therapy, gargle
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gargle/MouthwashDrug
Also called Gargling agent, Mouthrinse
There will be 50 patients in six study groups. Group A (n=10) patients on 10 ml gargle and nasal lavage using 0.2% Povidone-Iodine (Betadiene®) for 20-30 seconds, thrice daily for 6 days.
Group B (n=10) patients will be subjected to 10 ml gargle and nasal lavage using 1% Hydrogen peroxide (ActiveOxy®) for 20-30 seconds, thrice daily for 6 days.
Group C will comprised of (n=10) subjects on 10ml gargle and nasal lavage using Neem extract solution (Azardirachta indica) formulated locally) for 20-30 seconds, thrice daily for 6 days.
Group D (n=10) patients will use 2% hypertonic saline (Plabottle®) gargle and nasal lavage for a similar time period.
Group E (n=10) will serve as positive controls. These will be given simple distilled water gargles and nasal lavage for 20-30 seconds, thrice daily for six days Whereas Group F (n=5) will comprise of negative controls, who will not use any gargles or nasal lavage during study period.
| Study group | Role | What they receive |
|---|---|---|
| Povidone-Iodine 0.2% (BETADINE®) | Experimental | 0.2% Povidone-Iodine (BETADINE®) 10 ml gargle and nasal lavage for 20-30 seconds, thrice daily for 6 days. Receives: Drug: Gargle/Mouthwash |
| Hydrogen peroxide 1% (ActiveOxy) | Experimental | ActiveOxy (1% Hydrogen peroxide) 10 ml gargle and nasal lavage for 20-30 seconds, thrice daily for 6 days. Receives: Drug: Gargle/Mouthwash |
| Neem extract (Azadirachta indicia) | Active comparator | Neem extract (Azadirachta indicia) gargle will be prepared by chemistry laboratory. patients will do 10ml gargle and nasal lavage for 20-30 seconds, thrice daily for 6 days. Receives: Drug: Gargle/Mouthwash |
| Hypertonic saline (2%NaCl) | Active comparator | 10 ml gargle and nasal lavage using Hypertonic saline for 20-30 seconds, thrice daily for 6 days. Receives: Drug: Gargle/Mouthwash |
| Positive controls | Placebo comparator | 10 ml gargle and nasal lavage using distilled water for 20-30 seconds, thrice daily for 6 days. Receives: Drug: Gargle/Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoral viral load
Intraoral viral load as deciphered by RT-PCR
Measured: Five days of using gargles
Secondary outcomes (1)
Salivary cytokine profile
Salivary cytokine profiles of IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ and IL-17.
Measured: Five days of using gargles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Dec 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A quadruple blind randomized controlled trial followed by laboratory based analysis. Six parallel groups of participants using various gargles and nasal lavage.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Karachi
- Responsible party
- Principal investigator, Farhan Raza Khan, BDS, MS, FCPS, Aga Khan University
- Investigators
- Syed MR Kazmi, FCPS, Study director, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341688
- Sponsor's protocol ID
- 2020-Sur-ERC-4926
- Acronym
- GARGLES
- Status last verified
- Jul 2021
- First submitted
- 6 Apr 2020
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peng X, Xu X, Li Y, Cheng L, Zhou X, Ren B. Transmission routes of 2019-nCoV and controls in dental practice. Int J Oral Sci. 2020 Mar 3;12(1):9. doi: 10.1038/s41368-020-0075-9.
PubMed 32127517Shafiq HB, Amin U, Nawaz S. Comparative analysis of various antimicrobial agents present in locally available mouthwashes against oral pathogens. Pak J Pharm Sci. 2018 Sep;31(5):1881-1887.
PubMed 30150184Tanzer JM, Slee AM, Kamay BA. Structural requirements of guanide, biguanide, and bisbiguanide agents for antiplaque activity. Antimicrob Agents Chemother. 1977 Dec;12(6):721-9. doi: 10.1128/AAC.12.6.721.
PubMed 931371Lai P, Coulson C, Pothier DD, Rutka J. Chlorhexidine ototoxicity in ear surgery, part 1: review of the literature. J Otolaryngol Head Neck Surg. 2011 Dec;40(6):437-40.
PubMed 22420428Hirata K, Kurokawa A. Chlorhexidine gluconate ingestion resulting in fatal respiratory distress syndrome. Vet Hum Toxicol. 2002 Apr;44(2):89-91.
PubMed 11931511Eggers M, Koburger-Janssen T, Eickmann M, Zorn J. In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther. 2018 Jun;7(2):249-259. doi: 10.1007/s40121-018-0200-7. Epub 2018 Apr 9.
PubMed 29633177Tiwari V, Darmani NA, Yue BY, Shukla D. In vitro antiviral activity of neem (Azardirachta indica L.) bark extract against herpes simplex virus type-1 infection. Phytother Res. 2010 Aug;24(8):1132-40. doi: 10.1002/ptr.3085.
PubMed 20041417Ahmad A, Javed MR, Rao AQ, Husnain T. Designing and screening of universal drug from neem (Azadirachta indica) and standard drug chemicals against influenza virus nucleoprotein. BMC Complement Altern Med. 2016 Dec 16;16(1):519. doi: 10.1186/s12906-016-1469-2.
PubMed 27986088Ramalingam S, Graham C, Dove J, Morrice L, Sheikh A. A pilot, open labelled, randomised controlled trial of hypertonic saline nasal irrigation and gargling for the common cold. Sci Rep. 2019 Jan 31;9(1):1015. doi: 10.1038/s41598-018-37703-3.
PubMed 30705369Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Chen L, Liu HG, Liu W, Liu J, Liu K, Shang J, Deng Y, Wei S. [Analysis of clinical features of 29 patients with 2019 novel coronavirus pneumonia]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Feb 6;43(0):E005. doi: 10.3760/cma.j.issn.1001-0939.2020.0005. Online ahead of print. Chinese.
PubMed 32026671Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
PubMed 32085846Sharma R, Hebbal M, Ankola AV, Murugaboopathy V, Shetty SJ. Effect of two herbal mouthwashes on gingival health of school children. J Tradit Complement Med. 2014 Oct;4(4):272-8. doi: 10.4103/2225-4110.131373.
PubMed 25379471Chatterjee A, Saluja M, Singh N, Kandwal A. To evaluate the antigingivitis and antipalque effect of an Azadirachta indica (neem) mouthrinse on plaque induced gingivitis: A double-blind, randomized, controlled trial. J Indian Soc Periodontol. 2011 Oct;15(4):398-401. doi: 10.4103/0972-124X.92578.
PubMed 22368367Chava VR, Manjunath SM, Rajanikanth AV, Sridevi N. The efficacy of neem extract on four microorganisms responsible for causing dental caries viz Streptococcus mutans, Streptococcus salivarius, Streptococcus mitis and Streptococcus sanguis: an in vitro study. J Contemp Dent Pract. 2012 Nov 1;13(6):769-72. doi: 10.5005/jp-journals-10024-1227.
PubMed 23404001
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized Controlled Pilot Trial of Gargling Agents in Reducing Intraoral Viral Load Among Laboratory Confirmed COVID-19 Patients: GARGLES STUDY
- ClinicalTrials.gov ID
- NCT04341688
- Acronym / sponsor ID
- GARGLES / 2020-Sur-ERC-4926
- Conditions
- Covid-19
- Keywords
- Covid-19;, coronavirus disease, povidone, hydrogen peroxide, neem extracts, topical therapy, gargle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- University of Karachi
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pakistan is a resource restraint country, it's not possible to carry out coronavirus testing at mass scale. Simple cost effective intervention against the present pandemic is highly desirable.
For patients: Identifying an antiviral gargle that could substantially reduce the colonies of COVID-19 residing in mouth and oro-naso-pharynx is likely to reduce the viral load. Such reduction in the viral load through surface debridement could aid the effective immune response in improving the overall symptoms of the patients.
For dentists: This study is important because the nature of the dental profession involves aerosol production, carrying out dental work on asymptomatic patients carrying coronavirus puts the entire dental team at a great risk of not only acquiring the infection but also transmitting it to the others. Antiviral gargles could be used by dentist and their auxiliaries as prophylaxis.
For physicians and nurses: The risk of morbidity and mortality is high among physicians and nurses involved in the screening and management of Covid-19 patients. Globally, over 215 physicians and surgeons have died while taking care of Covid-19 patients. The cause of death is attributed to high exposure of viral load. The antiviral gargles and nasal lavage can decrease the fatalities among doctors and nurses.
Thus, patients, physicians, nurses and dentists, all could be benefited with this findings of this study.
Detailed description
It will be a parallel group, quadruple blind-randomized controlled pilot trial annexed with a laboratory based study. Clinical trial will be carried out at the Aga Khan University Hospital (AKUH), Karachi, Pakistan. Patients will be inducted from the pool of known patients (laboratory confirmed COVID-19 participants) within 7 days of the onset of viral infection symptoms, already admitted at AKUH. Molecular and immunological testing will be done at the Juma laboratory of AKUH. The intervention drugs (Povidone-Iodine, Hydrogen Peroxide and Hypertonic Saline will be obtained from the AKUH distribution department and/ or AKUH pharmacy. The Neem extract will be compounded at the Chemistry department, University of Karachi/ HEJ institute of Organic Chemistry, University of Karachi.
We will need 50 patients. There will be five study groups. Group A (n=10) patients on 10 ml gargle and nasal lavage with of 0.2% Povidone-Iodine for 20-30 seconds, twice daily for 5 days. Group B (n=10) patients will be subjected to 10 ml gargle and nasal lavage with 1% Hydrogen peroxide for 20-30 seconds, twice daily for 5 days. Group C will comprise of (n=10) subjects using 10ml gargle and nasal lavage with Neem extract (Azardirachta indica) for 20-30 seconds, twice daily for 5 days. Group D (n=10) patients will use 2% hypertonic saline gargle and nasal lavage for a similar time period. Group E (n=10) will serve as positive controls. These will be given simple distilled water gargles and nasal lavage for 20-30 seconds, thrice daily for six days. For nasal lavage, a special douche syringe will be provided to each participant. Its use will be thoroughly explained by the data collection officer.
Data collection: The baseline oral swab will be taken from the posterior pharyngeal wall/ tonsillar area on day one before initiating the gargles by trained dentist. The end-point oral swab will be taken on day 7, just after using the prescribed gargle. Patient will be provided with a special hood so that they themselves don't generate aerosol in the immediate vicinity while carrying out the gargling and nasal lavage.
Data will be analyzed using SPSS for Windows (version 23.0 SPSS) and Graph Pad Prism 7.0 software.
Mean and standard deviation of the continuous variables (age, COVID-19 viral counts and cytokine profiles at baseline and endpoint etc.) will be computed. Frequency distribution of the categorical variables will be determined (gender, co-morbids, presence of hypertension, diabetes, periodontal status etc.) Repeated measures ANOVA will be used to compare the reduction in intra-oral viral load and the changes in the inflammatory biomarkers in the study groups. In case of substantially low count of participants in the study groups, non-parametric tests such as Kruskal-Wallis or Friedman test will be employed. Multiple linear regression (MLR) will done to predict changes in the Covid-19 viral load and cytokine profiles. A subset analysis using Zero inflated negative binomial (ZINB) model will be employed, provided a significant reduction in viral load is observed in any of the study groups. A p-value of <0.05 will be taken as statistically significant. {20a}
The biases and confounders can be taken care at following four levels:
At recruitment stage, we will use restriction i.e. only those COVID positive subjects will be recruited who have no other major co-morbidities. At intervention assignment, the random group allocation will ensure even distribution of the confounders in the study groups thus their differential effect on the outcome will be addressed. At analysis, we will employ regression analysis (as described above) to account for biases and confounders and lastly, the subset analysis will stratify the data and nullify the effect of biases.
Interim analysis {20b} is not planned on account of a short duration of the study. Missing data/ uncompliant patients {20c} will be omitted from the final analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- A quadruple blind randomized controlled trial followed by laboratory based analysis. Six parallel groups of participants using various gargles and nasal lavage.
| Arm | Type | Receives |
|---|---|---|
| Povidone-Iodine 0.2% (BETADINE®) | Experimental | Drug: Gargle/Mouthwash0.2% Povidone-Iodine (BETADINE®) 10 ml gargle and nasal lavage for 20-30 seconds, thrice daily for 6 days. |
| Hydrogen peroxide 1% (ActiveOxy) | Experimental | Drug: Gargle/MouthwashActiveOxy (1% Hydrogen peroxide) 10 ml gargle and nasal lavage for 20-30 seconds, thrice daily for 6 days. |
| Neem extract (Azadirachta indicia) | Active comparator | Drug: Gargle/MouthwashNeem extract (Azadirachta indicia) gargle will be prepared by chemistry laboratory. patients will do 10ml gargle and nasal lavage for 20-30 seconds, thrice daily for 6 days. |
| Hypertonic saline (2%NaCl) | Active comparator | Drug: Gargle/Mouthwash10 ml gargle and nasal lavage using Hypertonic saline for 20-30 seconds, thrice daily for 6 days. |
| Positive controls | Placebo comparator | Drug: Gargle/Mouthwash10 ml gargle and nasal lavage using distilled water for 20-30 seconds, thrice daily for 6 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria are laboratory confirmed Covid-19 positive male or female subjects in the age range of 18-65 years, within seven days of the onset of mild to moderate symptoms of viral infection, already admitted in the hospital.
Key exclusion criteria (1 listed)
- Edentulous patients, patients with low Glasgow coma score, intubated, immune-compromised, history of radiotherapy or chemotherapy will be excluded. Patients with known pre-existing chronic mucosal lesions such as lichen planus will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gargle/MouthwashAlso: Gargling agent, MouthrinseThere will be 50 patients in six study groups. Group A (n=10) patients on 10 ml gargle and nasal lavage using 0.2% Povidone-Iodine (Betadiene®) for 20-30 seconds, thrice daily for 6 days. Group B (n=10) patients will be subjected to 10 ml gargle and nasal lavage using 1% Hydrogen peroxide (ActiveOxy®) for 20-30 seconds, thrice daily for 6 days. Group C will comprised of (n=10) subjects on 10ml gargle and nasal lavage using Neem extract solution (Azardirachta indica) formulated locally) for 20-30 seconds, thrice daily for 6 days. Group D (n=10) patients will use 2% hypertonic saline (Plabottle®) gargle and nasal lavage for a similar time period. Group E (n=10) will serve as positive controls. These will be given simple distilled water gargles and nasal lavage for 20-30 seconds, thrice daily for six days Whereas Group F (n=5) will comprise of negative controls, who will not use any gargles or nasal lavage during study period. | Drug | Hydrogen peroxide 1% (ActiveOxy), Hypertonic saline (2%NaCl), Neem extract (Azadirachta indicia), Positive controls, Povidone-Iodine 0.2% (BETADINE®) |
Primary outcome
Intraoral viral load
Time frame: Five days of using gargles
Intraoral viral load as deciphered by RT-PCR
1 secondary outcome
Salivary cytokine profile
Time frame: Five days of using gargles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Background: PubMed 32127517Peng X, Xu X, Li Y, Cheng L, Zhou X, Ren B. Transmission routes of 2019-nCoV and controls in dental practice. Int J Oral Sci. 2020 Mar 3;12(1):9. doi: 10.1038/s41368-020-0075-9.
- Background: PubMed 30150184Shafiq HB, Amin U, Nawaz S. Comparative analysis of various antimicrobial agents present in locally available mouthwashes against oral pathogens. Pak J Pharm Sci. 2018 Sep;31(5):1881-1887.
- Background: PubMed 931371Tanzer JM, Slee AM, Kamay BA. Structural requirements of guanide, biguanide, and bisbiguanide agents for antiplaque activity. Antimicrob Agents Chemother. 1977 Dec;12(6):721-9. doi: 10.1128/AAC.12.6.721.
- Background: PubMed 22420428Lai P, Coulson C, Pothier DD, Rutka J. Chlorhexidine ototoxicity in ear surgery, part 1: review of the literature. J Otolaryngol Head Neck Surg. 2011 Dec;40(6):437-40.
- Background: PubMed 11931511Hirata K, Kurokawa A. Chlorhexidine gluconate ingestion resulting in fatal respiratory distress syndrome. Vet Hum Toxicol. 2002 Apr;44(2):89-91.
- Background: PubMed 29633177Eggers M, Koburger-Janssen T, Eickmann M, Zorn J. In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther. 2018 Jun;7(2):249-259. doi: 10.1007/s40121-018-0200-7. Epub 2018 Apr 9.
- Background: PubMed 20041417Tiwari V, Darmani NA, Yue BY, Shukla D. In vitro antiviral activity of neem (Azardirachta indica L.) bark extract against herpes simplex virus type-1 infection. Phytother Res. 2010 Aug;24(8):1132-40. doi: 10.1002/ptr.3085.
- Background: PubMed 27986088Ahmad A, Javed MR, Rao AQ, Husnain T. Designing and screening of universal drug from neem (Azadirachta indica) and standard drug chemicals against influenza virus nucleoprotein. BMC Complement Altern Med. 2016 Dec 16;16(1):519. doi: 10.1186/s12906-016-1469-2.
- Background: PubMed 30705369Ramalingam S, Graham C, Dove J, Morrice L, Sheikh A. A pilot, open labelled, randomised controlled trial of hypertonic saline nasal irrigation and gargling for the common cold. Sci Rep. 2019 Jan 31;9(1):1015. doi: 10.1038/s41598-018-37703-3.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 32026671Chen L, Liu HG, Liu W, Liu J, Liu K, Shang J, Deng Y, Wei S. [Analysis of clinical features of 29 patients with 2019 novel coronavirus pneumonia]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Feb 6;43(0):E005. doi: 10.3760/cma.j.issn.1001-0939.2020.0005. Online ahead of print. Chinese.
- Background: PubMed 32085846Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
- Burden of disease in COVID-19 pandemicLink provided by the sponsor.
- Recommendation on elective and cosmetic dental procedures by ADALink provided by the sponsor.
- Report on mortality of doctors and nurses combating corona virus pandemicLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed MR Kazmi, FCPS study director
Aga Khan University
Questions about this trial
What is this clinical trial studying?
A study testing Gargle/Mouthwash in people with Covid-19, run by Aga Khan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farhan R Khan, MS, FCPS (03052225117, farhan.raza@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoral viral load (time frame: Five days of using gargles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04341688, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.