KCT0012281进行中（未招募）不适用
Efficacy, safety and economic evaluation of Bojungikgi-tang for fatigue in patients with persistent allergic rhinitis: randomized, double-blind, active comparator-controlled, multicenter, investigator-initiated clinical trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •Male or female adults aged 19 to 65 years.
- •A Fatigue Severity Scale (FSS) total score of 36 or higher.
- •A documented history of persistent allergic rhinitis for at least 2 years prior to study participation.
- •A positive result for perennial allergens on a skin allergy test (skin prick test or intradermal test), Multiple Allergen Simultaneous Test (MAST), or ImmunoCAP performed within the previous 12 months. Positivity is defined as follows:
- •Skin prick test: Wheal diameter =3 mm larger than the negative control.
- •Intradermal test: Wheal diameter =7 mm larger than the negative control.
- •MAST or ImmunoCAP: Class 2 or higher.
- •A 7-day average reflective Total Nasal Symptom Score (r-TNSS) of 5 or higher (maximum score: 12), assessed during the week preceding Visit
- •Willing and able to complete the study diary.
- •Voluntarily provides written informed consent to participate in this clinical trial.
排除标准
- •Individuals with non-allergic rhinitis (e.g., vasomotor, infectious, or drug-induced rhinitis).
- •Individuals with asthma.
- •Individuals with obstructive nasal polyps or other clinically significant nasal structural abnormalities (e.g., severe nasal septal deviation).
- •History of nasal trauma or surgery within 12 weeks prior to Visit
- •History of acute or chronic sinusitis within 4 weeks prior to Visit
- •Initiation or dose adjustment of allergen immunotherapy within 4 weeks prior to Visit
- •Current use of long-acting antihistamines.
- •Upper respiratory tract infection (including the common cold) or systemic infection within 2 weeks prior to Visit
- •Current or past history of underlying diseases that may cause fatigue, including but not limited to cancer, sleep disorders, active hepatitis A, chronic hepatitis, liver cirrhosis, chronic kidney disease, active tuberculosis, hypothyroidism, or multiple sclerosis.
- •Renal impairment (serum creatinine =2.0 × the upper limit of normal [ULN]).
- •Hepatic dysfunction (ALT or AST =2.0 × ULN).
- •Uncontrolled hypertension (diastolic blood pressure >100 mmHg or systolic blood pressure >180 mmHg).
- •Uncontrolled diabetes mellitus (random blood glucose =200 mg/dL at screening).
- •Use of prohibited concomitant medications or anticipated need for prohibited medications during the study period. Subjects may participate if the following medications have been discontinued for at least the specified washout period before screening:
- •Intranasal, topical, ophthalmic, or systemic antihistamines: 3 days (10 days for long-acting antihistamines such as loratadine, fexofenadine, or cetirizine; 14 days for ketotifen; 3 months for astemizole)
- •Intranasal cromolyn or nedocromil: 14 days
- •Anticholinergic agents: 3 days
- •Intranasal or systemic decongestants: 3 days
- •Topical or systemic corticosteroids: 30 days
- •Reserpine: 3 days
- •Antitussives or expectorants: 3 days
- •Leukotriene modifiers: 7 days
- •Systemic antibiotics: 14 days
- •Nonsteroidal anti-inflammatory drugs (NSAIDs): 2 days
- •Immunosuppressants: 90 days
- •Psychotropic medications: 30 days
- •Herbal medicines, traditional herbal preparations, or dietary supplements that may affect fatigue or allergic rhinitis: 14 days
- •Chronic use of medications that may affect the efficacy assessment of the investigational product, including tricyclic antidepressants, ß-agonists, or bronchodilators.
- •Fewer than 4 days of recorded reflective Total Nasal Symptom Score (r-TNSS) assessments in the subject diary during the week prior to Visit
- •Planned prolonged travel or absence from the study area during the study period that would interfere with study participation.
- •History of alcohol or drug abuse.
- •History of hypersensitivity to the investigational product or any of their ingredients/excipients.
- •Myopathy associated with hyperaldosteronism or hypokalemia.
- •Hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •Individuals unwilling to use medically acceptable contraception from the time of informed consent until completion of study participation.
- •? Acceptable contraceptive methods include:
- •An intrauterine device (IUD) with documented contraceptive efficacy used by the participant's partner;
- •Barrier contraception (male or female) used together with spermicide;
- •Surgical sterilization of the participant or partner (vasectomy, tubal ligation, or hysterectom
研究者
相似试验
进行中（未招募）
Unknown
Real-world Safety and Efficacy Study of Buzhong Yiqi Mixture in Patients with Spleen-Stomach Qi Deficiency SyndromePatients with Spleen-Stomach Qi Deficiency SyndromeMG22ITMCTR2026001749Zhejiang Hospital
招募中
1 期
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants with Advanced Solid Malignancies2024-511453-22-00Kumquat Biosciences Inc.112
招募中
不适用
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease (J2A-MC-GZPR)Peripheral Arterial DiseasejRCT20312505701,205
招募中
不适用
An Exploratory Study of novel diuretic therapy for cirrhotic ascitesLiver cirrhosis with uncontrolled ascites complicated by Type 2 diabetes mellitusjRCT103125078610
招募中
2 期
A study to evaluate the safety and efficacy of the tumor-targeting human antibody-cytokine fusion protein L19TNF plus lomustine in patients with glioblastoma at first progressionGlioblastoma2022-501822-39-00Philogen S.p.A.113