Allergic RhinitisNCT07899515
Efficacy and Safety of Xinyi Powder in Patients With Allergic Rhinitis and the Lung Deficiency and Cold Syndrome
A study testing Xinyi Powder in people with Allergic Rhinitis, run by Nanjing University of Traditional Chinese Medicine at 2 sites in China.
Trial summary
By observing the improvement of Xinyi Powder powder and simulated agent on the symptoms, symptom and sign scores, nasal symptom VAS scores, and quality of life of patients with allergic rhinitis due to lung deficiency and cold, the clinical efficacy of Xinyi Powder in the treatment of allergic rhinitis due to lung… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Xinyi Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 2 sitesChina
- Study dates
- 23 Oct 2024to 25 Jul 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for inclusion, patients must meet all of the following criteria:
- Meet the diagnostic criteria for allergic rhinitis (Western medicine), with a Total Nasal Symptom Score (TNSS) > 4; have a confirmed diagnosis of Seasonal Allergic Rhinitis (SAR) or Perennial Allergic Rhinitis (PAR) with seasonal exacerbation; and have an onset of the current episode within the past 4 weeks;
- Allergen testing: Positive results on skin prick test and/or serum-specific IgE assay;
- Meet the Traditional Chinese Medicine (TCM) syndrome diagnostic criteria for "Lung Deficiency with Cold Invasion";
- Aged 18 to 65 years (inclusive), regardless of gender; Voluntary participation in the trial and signing of a written informed consent form.
Who cannot join
- Patients meeting any of the following criteria must be excluded:
- Patients found to have nasal mucosal erosion, ulceration, or nasal septal perforation during the pre-enrollment nasal examination;
- Patients with other nasal conditions that might cause intranasal drug deposition, such as sinusitis, rhinitis medicamentosa, nasal polyps, or structural abnormalities of the nasal cavity;
- Patients who have undergone nasal surgery within the 12 months prior to screening;
- Patients currently receiving treatment for allergic conditions such as allergic rhinitis, allergic eczema, conjunctivitis, or asthma;
- Patients using systemic corticosteroids, those who have used intranasal glucocorticoids within 15 days prior to the study, or those undergoing long-term immunotherapy (exceeding 2 years);
Show all 12Show fewer
- Patients with abnormal liver or renal function (ALT or AST ≥ 1.5 times the upper limit of normal; Cr > upper limit of normal);
- Patients with severe underlying diseases, such as cardiovascular or cerebrovascular disease, or disorders affecting the liver, kidneys, respiratory system, or hematopoietic system;
- Pregnant or lactating women, or patients with psychiatric disorders;
- Patients with a known allergy to the investigational drug or its components;
- Patients who have participated in other clinical trials within the 3 months prior to screening;
- Other patients deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Jiangsu Provincial Second Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, 210017
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, 210023
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Xinyi Powder in the Treatment of Allergic Rhinitis With Lung Deficiency and Cold Syndrome
By observing the improvement of Xinyi Powder powder and simulated agent on the symptoms, symptom and sign scores, nasal symptom VAS scores, and quality of life of patients with allergic rhinitis due to lung deficiency and cold, the clinical efficacy of Xinyi Powder in the treatment of allergic rhinitis due to lung deficiency and cold is evaluated. It fully embodies the characteristics and advantages of traditional Chinese medicine treatment, provides new treatment methods for the clinical treatment of allergic rhinitis due to lung deficiency and cold, and provides objective basis for the development of new drugs.
- Conditions
- Allergic Rhinitis
- Being tested
- Xinyi Powder, Xinyi Powder placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xinyi PowderDrug
Also called Xinyi San
Xinyi Powder is a fixed Chinese herbal formula manufactured by the pharmaceutical preparation department of Jiangsu Province Hospital of Chinese Medicine. It consists of ten Chinese herbal medicines-Xinyi, Xixin, Gaoben, Shengma, Chuanxiong, Mutong, Fangfeng, Qianghuo, Baizhi, and Gancao-in equal proportions. The herbs are ground into a fine powder. The powdered herbs passed through an 80-mesh sieve, with at least 95% of the powder passing through a 100-mesh sieve. The preparation is packaged in 6-g sachets. Participants will take one sachet (6 g) orally twice daily, in the morning and evening after meals, with green tea for 14 consecutive days.
Xinyi Powder placeboDrug
Also called Xinyi San placebo
The Xinyi Powder placebo was manufactured by the pharmaceutical preparation department of Jiangsu Province Hospital of Chinese Medicine. It was prepared from a base material, colorant, and solvent through mixing, drying, grinding, and sieving. The placebo was designed to closely match Xinyi Powder in appearance, color, odor, and packaging. It was packaged in 6-g sachets and administered orally at one sachet twice daily, in the morning and evening after meals, with green tea for 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Xinyi Powder Placebo Group | Placebo comparator | Participants will receive Xinyi Powder placebo, one sachet (6 g) orally twice daily in the morning and evening after meals with tea for 14 consecutive days. Receives: Drug: Xinyi Powder placebo |
| Xinyi Powder Group | Experimental | Participants will receive Xinyi Powder, one sachet (6 g) orally twice daily in the morning and evening after meals with tea for 14 consecutive days. Receives: Drug: Xinyi Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score (TNSS)
The Total Nasal Symptom Score (TNSS) was used to assess four nasal symptoms: nasal congestion, rhinorrhea, nasal itching, and sneezing. Each symptom was rated on a 4-point scale from 0 to 3, with 0 indicating no symptoms and 3 indicating severe symptoms. The four item scores were summed to obtain a total score ranging from 0 to 12, with higher scores indicating greater symptom severity.
Measured: Baseline, Day 7 (±1 day), and Day 14 (±1 day)
Secondary outcomes (5)
Nasal Sign Score (inferior turbinate swelling score)
Nasal signs were assessed by examination of the nasal cavity, with the degree of inferior turbinate swelling rated on a 4-point scale from 0 to 3 according to the prespecified study criteria. A score of 0 indicated no swelling, whereas higher scores represented progressively greater inferior turbinate swelling.
Measured: baseline, Day 7 (±1 day), and Day 14 (±1 day)
Traditional Chinese Medicine syndrome score for Fei-deficiency and cold syndrome
The TCM syndrome score was assessed using the prespecified quantitative scale for Fei-deficiency and cold syndrome. The four principal symptoms-nasal congestion, rhinorrhea, nasal itching, and sneezing-were rated as 0, 2, 4, or 6 according to severity. Secondary symptoms and nasal signs were scored according to the prespecified study criteria. Individual item scores were summed to obtain the total TCM syndrome score, with higher scores indicating greater syndrome severity.
Measured: Baseline, Day 7 (±1 day), and Day 14 (±1 day)
Visual Analogue Scale (VAS) for nasal symptoms
The Visual Analogue Scale (VAS) was used to assess the daily severity of nasal symptoms. Participants rated their symptom severity on a 0-10 cm continuous scale, where 0 indicated no symptoms and 10 indicated the most severe symptoms imaginable. VAS assessments included four major nasal symptoms: nasal congestion, rhinorrhea, nasal itching, and sneezing. Participants completed the baseline assessment and recorded symptom scores daily after initiation of study medication for 14 consecutive days. Higher scores indicated greater symptom severity.
Measured: Baseline and daily during the 14-day treatment period (Day 1 to Day 14)
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
The 28-item Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was used to assess the impact of allergic rhinitis on health-related quality of life. The questionnaire covers seven domains: activity limitations, sleep problems, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional function. Each item is rated from 0 (not troubled) to 6 (extremely troubled). Overall and domain scores were calculated according to the questionnaire scoring method, with higher scores indicating greater impairment in quality of life.
Measured: Baseline, Day 7 (±1 day), and Day 14 (±1 day)
Total Non-Nasal Symptom Score (TNNSS)
The Total Non-Nasal Symptom Score (TNNSS) was used to assess associated symptoms, including postnasal drip, tearing, ocular itching, nasal or palatal itching, and headache. Each symptom was rated as absent (0) or present (1), and the individual scores were summed to obtain the total score. Higher scores indicated greater severity of associated symptoms.
Measured: Baseline, Day 7 (±1 day), and Day 14 (±1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start23 Oct 2024
- Primary completion25 Jul 2026
- Study completion25 Jul 2026
Why it stopped: Recruitment was stopped before the planned sample size was reached because the investigational product reached the end of its shelf life. The decision to stop recruitment was unrelated to interim efficacy or safety findings.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjun Wu, Nanjing University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899515
- Sponsor's protocol ID
- 012009200055
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Xinyi Powder in the Treatment of Allergic Rhinitis With Lung Deficiency and Cold Syndrome
- ClinicalTrials.gov ID
- NCT07899515
- Acronym / sponsor ID
- 012009200055
- Conditions
- Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was stopped before the planned sample size was reached because the investigational product reached the end of its shelf life. The decision to stop recruitment was unrelated to interim efficacy or safety findings.
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Nanjing University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 25 Jul 2026 (actual)
- Study completion
- 25 Jul 2026 (actual)
- First posted
- 27 Oct 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.
By observing the improvement of Xinyi Powder powder and simulated agent on the symptoms, symptom and sign scores, nasal symptom VAS scores, and quality of life of patients with allergic rhinitis due to lung deficiency and cold, the clinical efficacy of Xinyi Powder in the treatment of allergic rhinitis due to lung deficiency and cold is evaluated. It fully embodies the characteristics and advantages of traditional Chinese medicine treatment, provides new treatment methods for the clinical treatment of allergic rhinitis due to lung deficiency and cold, and provides objective basis for the development of new drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xinyi Powder Placebo Group | Placebo comparator | Drug: Xinyi Powder placeboParticipants will receive Xinyi Powder placebo, one sachet (6 g) orally twice daily in the morning and evening after meals with tea for 14 consecutive days. |
| Xinyi Powder Group | Experimental | Drug: Xinyi PowderParticipants will receive Xinyi Powder, one sachet (6 g) orally twice daily in the morning and evening after meals with tea for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet the diagnostic criteria for allergic rhinitis (Western medicine), with a Total Nasal Symptom Score (TNSS) > 4; have a confirmed diagnosis of Seasonal Allergic Rhinitis (SAR) or Perennial Allergic Rhinitis (PAR) with seasonal exacerbation; and have an onset of the current episode within the past 4 weeks;
- Allergen testing: Positive results on skin prick test and/or serum-specific IgE assay;
- Meet the Traditional Chinese Medicine (TCM) syndrome diagnostic criteria for "Lung Deficiency with Cold Invasion";
- Aged 18 to 65 years (inclusive), regardless of gender; Voluntary participation in the trial and signing of a written informed consent form.
Key exclusion criteria (12 listed)
- Patients found to have nasal mucosal erosion, ulceration, or nasal septal perforation during the pre-enrollment nasal examination;
- Patients with other nasal conditions that might cause intranasal drug deposition, such as sinusitis, rhinitis medicamentosa, nasal polyps, or structural abnormalities of the nasal cavity;
- Patients who have undergone nasal surgery within the 12 months prior to screening;
- Patients currently receiving treatment for allergic conditions such as allergic rhinitis, allergic eczema, conjunctivitis, or asthma;
- Patients using systemic corticosteroids, those who have used intranasal glucocorticoids within 15 days prior to the study, or those undergoing long-term immunotherapy (exceeding 2 years);
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 |
|---|---|---|
| Xinyi PowderAlso: Xinyi SanXinyi Powder is a fixed Chinese herbal formula manufactured by the pharmaceutical preparation department of Jiangsu Province Hospital of Chinese Medicine. It consists of ten Chinese herbal medicines-Xinyi, Xixin, Gaoben, Shengma, Chuanxiong, Mutong, Fangfeng, Qianghuo, Baizhi, and Gancao-in equal proportions. The herbs are ground into a fine powder. The powdered herbs passed through an 80-mesh sieve, with at least 95% of the powder passing through a 100-mesh sieve. The preparation is packaged in 6-g sachets. Participants will take one sachet (6 g) orally twice daily, in the morning and evening after meals, with green tea for 14 consecutive days. | Drug | Xinyi Powder Group |
| Xinyi Powder placeboAlso: Xinyi San placeboThe Xinyi Powder placebo was manufactured by the pharmaceutical preparation department of Jiangsu Province Hospital of Chinese Medicine. It was prepared from a base material, colorant, and solvent through mixing, drying, grinding, and sieving. The placebo was designed to closely match Xinyi Powder in appearance, color, odor, and packaging. It was packaged in 6-g sachets and administered orally at one sachet twice daily, in the morning and evening after meals, with green tea for 14 consecutive days. | Drug | Xinyi Powder Placebo Group |
Primary outcome
Total Nasal Symptom Score (TNSS)
Time frame: Baseline, Day 7 (±1 day), and Day 14 (±1 day)
The Total Nasal Symptom Score (TNSS) was used to assess four nasal symptoms: nasal congestion, rhinorrhea, nasal itching, and sneezing. Each symptom was rated on a 4-point scale from 0 to 3, with 0 indicating no symptoms and 3 indicating severe symptoms. The four item scores were summed to obtain a total score ranging from 0 to 12, with higher scores indicating greater symptom severity.
5 secondary outcomes
Nasal Sign Score (inferior turbinate swelling score)
Time frame: baseline, Day 7 (±1 day), and Day 14 (±1 day)
Traditional Chinese Medicine syndrome score for Fei-deficiency and cold syndrome
Time frame: Baseline, Day 7 (±1 day), and Day 14 (±1 day)
Visual Analogue Scale (VAS) for nasal symptoms
Time frame: Baseline and daily during the 14-day treatment period (Day 1 to Day 14)
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
Time frame: Baseline, Day 7 (±1 day), and Day 14 (±1 day)
Total Non-Nasal Symptom Score (TNNSS)
Time frame: Baseline, Day 7 (±1 day), and Day 14 (±1 day)
Results and safety
The study was stopped early (reason given: Recruitment was stopped before the planned sample size was reached because the investigational product reached the end of its shelf life. The decision to stop recruitment was unrelated to interim efficacy or safety findings.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
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 Xinyi Powder in people with Allergic Rhinitis, run by Nanjing University of Traditional Chinese Medicine at 2 sites 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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 27 Oct 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 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. 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 was stopped early (reason given: Recruitment was stopped before the planned sample size was reached because the investigational product reached the end of its shelf life. The decision to stop recruitment was unrelated to interim efficacy or safety findings.). Results are not available in the source record.
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?
Total Nasal Symptom Score (TNSS) (time frame: Baseline, Day 7 (±1 day), and Day 14 (±1 day)). 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 27 Oct 2026.