Allergic RhinitisNCT06709079
Study on the Effect and Mechanism of Aescine Sodium in the Treatment of Allergic Rhinitis
A study testing Aescine Sodium Tablets (Ocai®, Green Leaf Pharmaceuticals) in people with Allergic Rhinitis, run by Cheng Lei at 1 site in China.
Trial summary
Allergic rhinitis is a common chronic non-infectious inflammatory disease of the upper respiratory tract, which affects patients' health, quality of life and work efficiency for a long time. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Aescine Sodium Tablets (Ocai®, Green Leaf Pharmaceuticals)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Dec 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (18-65 years).
- Patients with allergic rhinitis were diagnosed based on clinical history and positive sensitization tests (skin prick test and/or specific IgE).
Who cannot join
- Received glucocorticoids, immunomodulatory, antihistamine drugs, and other medications that may affect the study results within the last 1 month.
- Nasal diseases such as upper respiratory tract infections, chronic sinusitis with or without nasal polyps, and nasal sinus tumors.
- History of nasal sinus surgery.
- With other immune and allergic diseases.
- Patients with a combination of severe cardiac, cerebrovascular or pulmonary - diseases, aspirin triad, primary ciliary dyskinesia, immune deficiency, and coagulation disorders.
- Pregnant women.
- Smokers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
Lei Cheng, +8613776620807, chenglei@jsph.org.cn
About this study
Allergic rhinitis is a common chronic non-infectious inflammatory disease of the upper respiratory tract, which affects patients' health, quality of life and work efficiency for a long time. Clinical manifestations are mainly nasal congestion, paroxysmal sneezing, clear watery nasal discharge and nasal itching, among which nasal congestion caused by nasal mucosal edema is the main manifestation of allergic rhinitis. Nasal mucosa has a rich network of arteriovenous anastomosis, and there are many large venous sinuses constitute a spongy structure, with a strong capacity for expansion and contraction, in the onset of allergic rhinitis, the volume of venous sinuses in the nasal mucosa can be rapidly changed, venous sinus expansion and filling can be induced by nasal mucosal congestion and nasal mucosal edema nasal congestion symptoms. Aescine sodium has been widely used in the clinical treatment of local tissue edema and the effect is remarkable, a large number of clinical results have proved that it has a significant anti-inflammatory, anti-edema, enhance the venous tension, improve blood circulation and anti-allergic effect, can be improved through the improvement of the vascular endothelial cell barrier, and enhance the epithelial cells close connection to improve the local edema and acute inflammation. The current treatment strategies for allergic rhinitis mainly include environmental control, medication, immunotherapy and health education, however, some patients are still unable to effectively control their symptoms in the long term after standardized treatment, and nasal congestion and runny nose cause great disturbance to the quality of their daily life. Therefore, it is urgent to investigate the mechanism of aescine sodium in relieving nasal mucosal edema in allergic rhinitis.
- Conditions
- Allergic Rhinitis
- Being tested
- Aescine Sodium Tablets (Ocai®, Green Leaf Pharmaceuticals)
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aescine Sodium Tablets (Ocai®, Green Leaf Pharmaceuticals)Drug
Preoperatively, patients with AR were given 2 tablets of Aescine Sodium Tablets (Ocai®, Green Leaf Pharmaceuticals) to be taken after meals, once in the morning and once in the evening, for a period of 20 days.
| Study group | Role | What they receive |
|---|---|---|
| Allergic rhinitis | Experimental | Preoperatively, patients with AR were given 2 tablets of Aescine Sodium Tablets (Ocai®, Green Leaf Pharmaceuticals) to be taken after meals, once in the morning and once in the evening, for a period of 20 days. Receives: Drug: Aescine Sodium Tablets (Ocai®, Green Leaf Pharmaceuticals) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhinoconjunctivitis Quality of Life Questionnaire
To measure the functional impairments that are most troublesome to adult patients as a result of their rhinoconjunctivitis. Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure. 7-point scale (0 = not impaired at all - 6 = severely impaired). Higher scores reflect lower quality of life.
Measured: baseline and 20 days
Visual analogue scale
Results Visual analogue scale(VAS) are well validated for the measurement of AR symptoms and correlate well with the ARIA (allergic rhinitis and its impact on asthma) severity classification. Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure.
Range: 0-10. Higher scores reflect more pain and severity.
Measured: baseline and 20 days
The concentration of interleukin 4(IL-4), interleukin 5(IL-5), interleukin 13(IL-13)
It reflects Th2 immune response in patients with allergic rhinitis.
Measured: baseline and 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng Lei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cheng Lei, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709079
- Sponsor's protocol ID
- 2023-SR-796
- Status last verified
- Dec 2024
- First submitted
- 21 Jan 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al-Digheari A, Mahboub B, Tarraf H, Yucel T, Annesi-Maesano I, Doble A, Lahlou A, Tariq L, Aziz F, El Hasnaoui A. The clinical burden of allergic rhinitis in five Middle Eastern countries: results of the SNAPSHOT program. Allergy Asthma Clin Immunol. 2018 Nov 19;14:63. doi: 10.1186/s13223-018-0298-x. eCollection 2018.
PubMed 30473712Cheng L, Chen J, Fu Q, He S, Li H, Liu Z, Tan G, Tao Z, Wang D, Wen W, Xu R, Xu Y, Yang Q, Zhang C, Zhang G, Zhang R, Zhang Y, Zhou B, Zhu D, Chen L, Cui X, Deng Y, Guo Z, Huang Z, Huang Z, Li H, Li J, Li W, Li Y, Xi L, Lou H, Lu M, Ouyang Y, Shi W, Tao X, Tian H, Wang C, Wang M, Wang N, Wang X, Xie H, Yu S, Zhao R, Zheng M, Zhou H, Zhu L, Zhang L. Chinese Society of Allergy Guidelines for Diagnosis and Treatment of Allergic Rhinitis. Allergy Asthma Immunol Res. 2018 Jul;10(4):300-353. doi: 10.4168/aair.2018.10.4.300.
PubMed 29949830Lee HC, Yu HP, Liao CC, Chou AH, Liu FC. Escin protects against acetaminophen-induced liver injury in mice via attenuating inflammatory response and inhibiting ERK signaling pathway. Am J Transl Res. 2019 Aug 15;11(8):5170-5182. eCollection 2019.
PubMed 31497232Lindner I, Meier C, Url A, Unger H, Grassauer A, Prieschl-Grassauer E, Doerfler P. Beta-escin has potent anti-allergic efficacy and reduces allergic airway inflammation. BMC Immunol. 2010 May 21;11:24. doi: 10.1186/1471-2172-11-24.
PubMed 20487574Gallelli L. Escin: a review of its anti-edematous, anti-inflammatory, and venotonic properties. Drug Des Devel Ther. 2019 Sep 27;13:3425-3437. doi: 10.2147/DDDT.S207720. eCollection 2019.
PubMed 31631970
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect and Mechanism of Aescine Sodium in the Treatment of Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT06709079
- Acronym / sponsor ID
- 2023-SR-796
- Conditions
- Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cheng LeiUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 Nov 2024 (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.
Allergic rhinitis is a common chronic non-infectious inflammatory disease of the upper respiratory tract, which affects patients' health, quality of life and work efficiency for a long time. Clinical manifestations are mainly nasal congestion, paroxysmal sneezing, clear watery nasal discharge and nasal itching, among which nasal congestion caused by nasal mucosal edema is the main manifestation of allergic rhinitis. Nasal mucosa has a rich network of arteriovenous anastomosis, and there are many large venous sinuses constitute a spongy structure, with a strong capacity for expansion and contraction, in the onset of allergic rhinitis, the volume of venous sinuses in the nasal mucosa can be rapidly changed, venous sinus expansion and filling can be induced by nasal mucosal congestion and nasal mucosal edema nasal congestion symptoms. Aescine sodium has been widely used in the clinical treatment of local tissue edema and the effect is remarkable, a large number of clinical results have proved that it has a significant anti-inflammatory, anti-edema, enhance the venous tension, improve blood circulation and anti-allergic effect, can be improved through the improvement of the vascular endothelial cell barrier, and enhance the epithelial cells close connection to improve the local edema and acute inflammation. The current treatment strategies for allergic rhinitis mainly include environmental control, medication, immunotherapy and health education, however, some patients are still unable to effectively control their symptoms in the long term after standardized treatment, and nasal congestion and runny nose cause great disturbance to the quality of their daily life. Therefore, it is urgent to investigate the mechanism of aescine sodium in relieving nasal mucosal edema in allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allergic rhinitis | Experimental | Drug: Aescine Sodium Tablets (Ocai®, Green Leaf Pharmaceuticals)Preoperatively, patients with AR were given 2 tablets of Aescine Sodium Tablets (Ocai®, Green Leaf Pharmaceuticals) to be taken after meals, once in the morning and once in the evening, for a period of 20 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (18-65 years).
- Patients with allergic rhinitis were diagnosed based on clinical history and positive sensitization tests (skin prick test and/or specific IgE).
Key exclusion criteria (7 listed)
- Received glucocorticoids, immunomodulatory, antihistamine drugs, and other medications that may affect the study results within the last 1 month.
- Nasal diseases such as upper respiratory tract infections, chronic sinusitis with or without nasal polyps, and nasal sinus tumors.
- History of nasal sinus surgery.
- With other immune and allergic diseases.
- Patients with a combination of severe cardiac, cerebrovascular or pulmonary - diseases, aspirin triad, primary ciliary dyskinesia, immune deficiency, and coagulation disorders.
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 |
|---|---|---|
| Aescine Sodium Tablets (Ocai®, Green Leaf Pharmaceuticals)Preoperatively, patients with AR were given 2 tablets of Aescine Sodium Tablets (Ocai®, Green Leaf Pharmaceuticals) to be taken after meals, once in the morning and once in the evening, for a period of 20 days. | Drug | Allergic rhinitis |
Primary outcome
Rhinoconjunctivitis Quality of Life Questionnaire
Time frame: baseline and 20 days
To measure the functional impairments that are most troublesome to adult patients as a result of their rhinoconjunctivitis. Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure. 7-point scale (0 = not impaired at all - 6 = severely impaired). Higher scores reflect lower quality of life.
Visual analogue scale
Time frame: baseline and 20 days
Results Visual analogue scale(VAS) are well validated for the measurement of AR symptoms and correlate well with the ARIA (allergic rhinitis and its impact on asthma) severity classification. Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure. Range: 0-10. Higher scores reflect more pain and severity.
The concentration of interleukin 4(IL-4), interleukin 5(IL-5), interleukin 13(IL-13)
Time frame: baseline and 20 days
It reflects Th2 immune response in patients with allergic rhinitis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Background: PubMed 30473712Al-Digheari A, Mahboub B, Tarraf H, Yucel T, Annesi-Maesano I, Doble A, Lahlou A, Tariq L, Aziz F, El Hasnaoui A. The clinical burden of allergic rhinitis in five Middle Eastern countries: results of the SNAPSHOT program. Allergy Asthma Clin Immunol. 2018 Nov 19;14:63. doi: 10.1186/s13223-018-0298-x. eCollection 2018.
- Background: PubMed 29949830Cheng L, Chen J, Fu Q, He S, Li H, Liu Z, Tan G, Tao Z, Wang D, Wen W, Xu R, Xu Y, Yang Q, Zhang C, Zhang G, Zhang R, Zhang Y, Zhou B, Zhu D, Chen L, Cui X, Deng Y, Guo Z, Huang Z, Huang Z, Li H, Li J, Li W, Li Y, Xi L, Lou H, Lu M, Ouyang Y, Shi W, Tao X, Tian H, Wang C, Wang M, Wang N, Wang X, Xie H, Yu S, Zhao R, Zheng M, Zhou H, Zhu L, Zhang L. Chinese Society of Allergy Guidelines for Diagnosis and Treatment of Allergic Rhinitis. Allergy Asthma Immunol Res. 2018 Jul;10(4):300-353. doi: 10.4168/aair.2018.10.4.300.
- Background: PubMed 31497232Lee HC, Yu HP, Liao CC, Chou AH, Liu FC. Escin protects against acetaminophen-induced liver injury in mice via attenuating inflammatory response and inhibiting ERK signaling pathway. Am J Transl Res. 2019 Aug 15;11(8):5170-5182. eCollection 2019.
- Background: PubMed 20487574Lindner I, Meier C, Url A, Unger H, Grassauer A, Prieschl-Grassauer E, Doerfler P. Beta-escin has potent anti-allergic efficacy and reduces allergic airway inflammation. BMC Immunol. 2010 May 21;11:24. doi: 10.1186/1471-2172-11-24.
- Background: PubMed 31631970Gallelli L. Escin: a review of its anti-edematous, anti-inflammatory, and venotonic properties. Drug Des Devel Ther. 2019 Sep 27;13:3425-3437. doi: 10.2147/DDDT.S207720. eCollection 2019.
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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.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aescine Sodium Tablets (Ocai®, Green Leaf Pharmaceuticals) in people with Allergic Rhinitis, run by Cheng Lei at 1 site in China.
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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhinoconjunctivitis Quality of Life Questionnaire (time frame: baseline and 20 days). The study lists 3 primary outcomes in all. 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 NCT06709079, which also lists 5 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 5 Dec 2024.