An interventional study of Xinyi Powder and Xinyi Powder placebo in Allergic Rhinitis, sponsored by Nanjing University of Traditional Chinese Medicine. Terminated at 2 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Nanjing University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's enrollment of 228 is above the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →Nanjing University of Traditional Chinese Medicine is the lead sponsor of 17 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible for inclusion, patients must meet all of the following criteria:
Exclusion Criteria:
Patients meeting any of the following criteria must be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Xinyi Powder placebo
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.
Drug: Xinyi Powder
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.
Also known as: Xinyi San
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.
Also known as: Xinyi San placebo
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.
Time frame: Baseline, Day 7 (±1 day), and Day 14 (±1 day)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Day 7 (±1 day), and Day 14 (±1 day)
Number of Participants With Clinically Significant Laboratory Abnormalities
Laboratory safety assessments include hematology (red blood cell count, white blood cell count, neutrophil percentage, lymphocyte percentage, platelet count, and hemoglobin), serum biochemistry (ALT, AST, serum creatinine, and blood urea nitrogen), and urinalysis (urine protein, glucose, ketones, occult blood, white blood cell count, and red blood cell count). Findings will be categorized as normal, abnormal without clinical significance, abnormal with clinical significance, or not tested. At each assessment, participants with at least one clinically significant laboratory abnormality will be counted once, regardless of the number of abnormal parameters.
Time frame: Baseline and Day 14 (±1 day)
Number of Participants With Clinically Significant ECG Abnormalities
Electrocardiogram (ECG) examinations will include assessment of heart rate, corrected QT (QTc) interval, and other ECG findings. Results will be classified as normal or abnormal, and abnormal findings will be evaluated for clinical significance by the investigator. The number of participants with at least one clinically significant ECG abnormality will be reported at each assessment time point.
Time frame: baseline and Day 14 (±1 day)
Systolic Blood Pressure
Systolic blood pressure will be measured in millimeters of mercury (mmHg) and recorded at each scheduled assessment.
Time frame: baseline, Day 7 (±1 day), and Day 14 (±1 day)
Diastolic Blood Pressure
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) and recorded at each scheduled assessment.
Time frame: Baseline, Day 7 (±1 day), and Day 14 (±1 day)
Heart Rate
Heart rate will be measured in beats per minute (bpm) and recorded at each scheduled assessment.
Time frame: Baseline, Day 7 (±1 day), and Day 14 (±1 day)
Respiratory Rate
Respiratory rate will be measured in breaths per minute and recorded at each scheduled assessment.
Time frame: Baseline, Day 7 (±1 day), and Day 14 (±1 day)
Body Temperature
Body temperature will be measured in degrees Celsius (°C) and recorded at each scheduled assessment.
Time frame: Baseline, Day 7 (±1 day), and Day 14 (±1 day)
Ran from Oct 2024 to primary completion in Jul 2026, 21 months.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Nanjing University of Traditional Chinese Medicine