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Efficacy and Safety of Mucoadhesive Sustained Release, Mucodentol, in Comparison With Hydroxychloroquine to Prevent COVID-19

Efficacy and Safety of Mucoadhesive Sustained Release, Mucodentol, in Comparison With Hydroxychloroquine to Prevent COVID-19 Disease in Healthcare Providers at Baqiyatallah Hospital in Tehran

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04466280
Enrollment
0
Registered
2020-07-10
Start date
2020-08-12
Completion date
2020-09-21
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Brief summary

180 people from the medical staff and high-risk people in Baqiyatallah Hospital, who are in close contact with patients, will enter the study. Participants will be divided into two intervention groups and one control group. The control group will use the full protective equipment assigned to the treatment staff. In addition to protective equipment, the first intervention team will receive a daily diet of 200 mg hydroxychloroquine tablets. The second intervention team, while observing and using the complete protective equipment, will place a thin layer of Mucodentol gel in the vestibular area of the mouth daily, every 6 to 8 hours. At the beginning of the treatment, qualified people will participate in the study while recording demographic and clinical information, PCR test will be performed, and if they have negative PCR, they will be in one of the 3 study groups. During the study, if the symptoms of the disease occur in each of the participants, the test will be taken again. If the test is positive, the person will withdraw from the study, and the patient's information will be recorded. Finally, the people present in the study will be tested for PCR, and the results of the disease and the side effects of the drugs will be compared.

Interventions

DRUGHydroxychloroquine

200 mg of hydroxychloroquine daily for participants in the intervention group 1

DRUGMucodentol

Intervention Group 2 participants will place a thin layer of Dentol gel in the vestibular area of the mouth every 6 to 8 hours.

DEVICEPersonal protective equipment

Personal protective equipment such as masks, gloves, protective shields

Sponsors

Baqiyatallah Medical Sciences University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Negative PCR testing through throat swabs * Signing Conscious Consent

Exclusion criteria

* History of ocular complications and visual disturbances * Sensitivity to plant compounds in the product

Design outcomes

Primary

MeasureTime frameDescription
PCR testup to 1 monthLaboratory PCR testing can help diagnose the disease

Secondary

MeasureTime frameDescription
Laboratory Treatment Responseup to 1 monthNormal blood cell count and CRP count (normal laboratory range)
drug reactions Adverseup to 1 monthComplications in both groups should be evaluated and evaluated during treatment.
Allergic drugup to 1 monthThere will be known allergic reactions to the drugs.
Radiological Treatment Responseup to 1 monthCT scans help determine how much the lungs are affected by COVID-19.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026