Rhino SinusitisNCT07534280
Herbal Tea Extract for Management of Rhinosinusitis
A study testing mango leaves extract, local steroids and nasal saline in people with Rhino Sinusitis, run by Deraya University at 2 sites in Egypt.
Trial summary
The objective of this phase I controlled clinical trial is to determine the safety and efficacy of Berry leaves \& Mango leaves mixture in symptomatic treatments on disease-related quality of life in adults with clinically diagnosed acute rhinosinusitis. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhino Sinusitis
- What is being tested?
- mango leaves extract, local steroids and nasal saline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Nov 2025to 1 Mar 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject must have symptoms of acute bacterial rhinosinusitis.
- The subject should be able to be self-assessed as moderate, severe, or very severe.
- The subject must have access to a phone.
- The subject must accept sharing and sign consent.
- The subject should follow instructions carefully and not miss times of assessment
Who cannot join
- The subject has an allergy to: Flavonoids, phenolic acids, anthocyanins, carotenoids.
- The subject has complications of sinusitis (facial edema, cellulitis, or orbital, meningeal or cerebral signs).
- The subject is pregnancy.
- The subject has a comorbidity that may impair their immune response (such as immunodeficiency disease, uncontrolled cancer, or chemotherapy or radiation treatment).
- The subject has cystic fibrosis
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Soad A. Mohamad
Minya, Minya Governorate, 05673
Deraya university
Minya, 05673
About this study
Official title: Efficacy of Berry Leaves & Mango Leaves Mixture in Symptomatic Treatments on Disease-related Quality of Life in Adults With Clinically Diagnosed Acute Rhinosinusitis
The objective of this phase I controlled clinical trial is to determine the safety and efficacy of Berry leaves \& Mango leaves mixture in symptomatic treatments on disease-related quality of life in adults with clinically diagnosed acute rhinosinusitis. Ten adult subjects, 18 to 70 years old, who meet the recommended criteria for acute rhinosinusitis, will be enrolled from Minia university ENT outpatient Clinic. Subjects will be advised to add Berry leaves \& Mango leaves herbal tea mixture and followed for one month with their routine therapy (an oral decongestant, a nasal saline spray, and an antitussive agent except analgesic). Subject outcomes will be assessed by telephone interview at 0, 3, 7, 10, and 28 days. The Quality-of-life outcomes are measured on Day 3, 10 and 28 with SNOT-16, a validated evaluative instrument.
- Conditions
- Rhino Sinusitis
- Being tested
- mango leaves extract, local steroids, nasal saline, amoxicillin clavulanates
- Keywords
- rhinosinusitis, Mango leaf, steroids, SNOT-16
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mango leaves extractDietary supplement
herbal tea 3 times/day
local steroidsDrug
local steroids once daily
nasal salineOther
nasal irrigation on need
amoxicillin clavulanatesDrug
500 mg 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| herbal tea group | Experimental | Herbal tea 3 mgs three times a day plus oral antibiotic Receives: Dietary Supplement: mango leaves extract; Drug: amoxicillin clavulanates |
| Routine therapy | Active comparator | Steroid plus oral antibiotics in their normal doses Receives: Drug: local steroids; Drug: amoxicillin clavulanates |
| Nasal irrigation Plus antibiotic | Placebo comparator | Nasal irrigation daily Plus oral antibiotics Receives: Other: nasal saline; Drug: amoxicillin clavulanates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of SNOT 16 score after treatment
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start20 Nov 2025
- Primary completion10 Jan 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhino SinusitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soad Ali, Deraya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534280
- Sponsor's protocol ID
- 3 April 2026
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Berry Leaves & Mango Leaves Mixture in Symptomatic Treatments on Disease-related Quality of Life in Adults With Clinically Diagnosed Acute Rhinosinusitis
- ClinicalTrials.gov ID
- NCT07534280
- Acronym / sponsor ID
- 3 April 2026
- Conditions
- Rhino Sinusitis
- Keywords
- rhinosinusitis, Mango leaf, steroids, SNOT-16
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 16 Apr 2026 (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.
The objective of this phase I controlled clinical trial is to determine the safety and efficacy of Berry leaves \& Mango leaves mixture in symptomatic treatments on disease-related quality of life in adults with clinically diagnosed acute rhinosinusitis. Ten adult subjects, 18 to 70 years old, who meet the recommended criteria for acute rhinosinusitis, will be enrolled from Minia university ENT outpatient Clinic. Subjects will be advised to add Berry leaves \& Mango leaves herbal tea mixture and followed for one month with their routine therapy (an oral decongestant, a nasal saline spray, and an antitussive agent except analgesic). Subject outcomes will be assessed by telephone interview at 0, 3, 7, 10, and 28 days. The Quality-of-life outcomes are measured on Day 3, 10 and 28 with SNOT-16, a validated evaluative instrument.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| herbal tea group | Experimental | Dietary Supplement: mango leaves extract, Drug: amoxicillin clavulanatesHerbal tea 3 mgs three times a day plus oral antibiotic |
| Routine therapy | Active comparator | Drug: local steroids, Drug: amoxicillin clavulanatesSteroid plus oral antibiotics in their normal doses |
| Nasal irrigation Plus antibiotic | Placebo comparator | Other: nasal saline, Drug: amoxicillin clavulanatesNasal irrigation daily Plus oral antibiotics |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject must have symptoms of acute bacterial rhinosinusitis.
- The subject should be able to be self-assessed as moderate, severe, or very severe.
- The subject must have access to a phone.
- The subject must accept sharing and sign consent.
- The subject should follow instructions carefully and not miss times of assessment
Key exclusion criteria (5 listed)
- The subject has an allergy to: Flavonoids, phenolic acids, anthocyanins, carotenoids.
- The subject has complications of sinusitis (facial edema, cellulitis, or orbital, meningeal or cerebral signs).
- The subject is pregnancy.
- The subject has a comorbidity that may impair their immune response (such as immunodeficiency disease, uncontrolled cancer, or chemotherapy or radiation treatment).
- The subject has cystic fibrosis
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 |
|---|---|---|
| mango leaves extractherbal tea 3 times/day | Dietary supplement | herbal tea group |
| local steroidslocal steroids once daily | Drug | Routine therapy |
| nasal salinenasal irrigation on need | Other | Nasal irrigation Plus antibiotic |
| amoxicillin clavulanates500 mg 3 times a day | Drug | Nasal irrigation Plus antibiotic, Routine therapy, herbal tea group |
Primary outcome
Reduction of SNOT 16 score after treatment
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mango leaves extract, local steroids and nasal saline in people with Rhino Sinusitis, run by Deraya University at 2 sites in Egypt.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of SNOT 16 score after treatment (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2026.