Effectiveness and Clinical Mechanism of Huanglian-Jiedu Decoction in Patients With Intense-exuberant Stomach Fire Syndrome (Acute Pericoronitis, Minor Recurrent Aphthous Stomatitis and Recurrent Herpes Simplex Labialis)
试验速览
- 阶段
- 1 期
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Change from baseline in the Intense-Exuberant Stomach Fire Syndrome scores
研究概览
简要总结
This clinical research focus on evaluating the effectiveness of Huanglian-Jiedu Decoction in patients with intense-exuberant stomach fire syndrome (one of the common TCM syndrome)of acute pericoronitis,minor recurrent aphthous stomatitis and recurrent herpes simplex labialis,meanwhile, exploring the pharmacological mechanism and potential biomarkers of this traditional formula.
详细描述
Huanglian-Jiedu Decoction, as a traditional Chinese medicine formula，includes 4 kinds of Chinese herbs as following: Huanglian (Rhizoma Coptidis), Huangbo (Cortex Phellodendri), Huangqin (Scutellaria baicalensis) and Zhizi (Scutellaria baicalensis). Huanglian-Jiedu Decoction has been recorded to be effective in many diseases that belong to the syndrome of intense-exuberant stomach fire from thousands years of clinical practice, just like acute pericoronitis, minor recurrent aphthous stomatitis and recurrent herpes simplex labialis,etc. While its clinical pharmacological mechanism has not been clearly illustrated. In this study, the investigators focus on evaluating the effectiveness of Huanglian-Jiedu Decoction in patients with intense-exuberant stomach fire syndrome (including three disease: acute pericoronitis, minor recurrent aphthous stomatitis and recurrent herpes simplex labialis), and exploring the pharmacological mechanism and potential biomarkers of this traditional formula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General inclusion criteria:
- •Female or male patients.
- •Age: 18 - 60 years.
- •Meeting the diagnostic criteria of Intense-Exuberant Stomach Fire Syndrome according to the traditional Chinese medicine.
- •Patient is willing to participate voluntarily and to sign a written patient informed consent.
- •Disease-specific inclusion criteria for patients with acute pericoronitis:
- •Patients with clinical diagnosis of acute pericoronitis and without treatment before the study began.
- •Disease-specific inclusion criteria for patients with minor recurrent aphthous stomatitis:
- •Patients with clinical diagnosis of minor recurrent aphthous stomatitis(MiRAS).
- •A history of MiRAS for more than 6 months and an expectation that the ulcers normally take 5 or more days to resolve without treatment.
- •Ulcer occurred less than 48h hours' duration without treatment.
- •Disease-specific inclusion criteria for recurrent herpes simplex labialis
- •Patients with clinical diagnosis of recurrent herpes simplex labialis.
- •History of recurrent herpes labialis averaging 1 or more episodes per year.
- •Onset of prodrome, erythema or vesicle within 48 hours without treatment.
排除标准
- •General exclusion criteria:
- •Patients with severe cardiac dysfunction on the grade of heart function over Ⅲ grade and/or liver function impairment with the value of ALT over 1.5-fold of normal value and/or renal dysfunction with the value over 133μmol/L.
- •Patients who have serious, unstable, or clinically significant medical or psychological conditions, which, in the opinion of the investigator(s), would compromise the subject's participation in the study (including but not limited to arrhythmia, uncontrolled hypertension, diabetes, hepatitis, kidney failure, AIDS, cancer, etc.
- •Women during pregnancy, lactation , breastfeeding or having child bearing potential without use an adequate method of birth control.
- •Patients who known allergy to the study drug or the Huanglian (Rhizoma Coptidis), Huangbo (Cortex Phellodendri), Huangqin (Scutellaria baicalensis) and Zhizi (Scutellaria baicalensis ( Patients who are insufficiency of the spleen-yang according to the TCM should be exclude ).
- •Patients participating in or having participated in other clinical studies in the 3 months prior to this clinical trial.
- •Patients who are considered unreliable as to medication compliance or adherence to scheduled appointments.
- •Disease-specific exclusion criteria for acute pericoronitis:
- •Patients who smoked at least 20 cigarettes per day（heavy smokers）.
- •Patients with fascial space infection of maxillofacial region or/and chronic periodontitis.
- •Patients with periodontal disease in the region of the acute pericoronitis.
- •Patients who had systemic administration of antibiotics within the past 4 weeks
- •Disease-specific exclusion criteria for minor recurrent aphthous stomatitis(MiRAS):
- •Patients with history of drug abuse within the past 6 months.
- •Patients who smoked at least 20 cigarettes per day（heavy smokers）.
- •Patients with ulcers as a manifestation of a systemic disease process such as ulcerative colitis, Behcet's syndrome, Reiter' s syndrome or immune deficiency.
- •Patients who had systemic administration of antibiotics within the past 4 weeks or/ and had treatment with systemic steroid or immunomodulatory within 3 month before the study entry.
- •Patients who had orthodontic braces or retainer that might contact with the ulcer.
- •Disease-specific exclusion criteria for recurrent herpes simplex labialis:
- •Patients with fever > 38.5℃, and / or blood WBC>11.0x109/L, and / or neutrophil >85%.
- •Patients who had systemic administration of antibiotics within the past 4 weeks or/ and had treatment with immunomodulatory within 3 month before the study entry.
研究组 & 干预措施
Huanglian-Jiedu Decoction in acute pericoronitis
All eligible patients entering this group will receive Huanglian-Jiedu Decoction(prepared as granule). 1 bag per time and twice a day for 5 days.
干预措施: Huanglian-Jiedu Decoction (Drug)
Huanglian-Jiedu Decoction in recurrent aphthous stomatitis
All eligible patients entering this group will receive Huanglian-Jiedu Decoction(prepared as granule). 1 bag per time and twice a day for 5 days.
干预措施: Huanglian-Jiedu Decoction (Drug)
Huanglian-Jiedu Decoction in recurrent herpes simplex labialis
All eligible patients entering this group will receive Huanglian-Jiedu Decoction(prepared as granule). 1 bag per time and twice a day for 5 days.
干预措施: Huanglian-Jiedu Decoction (Drug)
结局指标
主要结局
Change from baseline in the Intense-Exuberant Stomach Fire Syndrome scores
时间窗: Day 0,Day 3,Day 5
Intense-Exuberant Stomach Fire Syndrome scores were questionnaires that consists of basic symptoms and disease-specific symptoms that described in traditional Chinese medicine. The basic symptoms included feverish sensation, thirst that preferring cold drink, bad breath, flushed face, bound stool, scanty yellowish urine, red tongue with dry and yellowish fur, and the forceful or rapid pulse. The disease-specific symptoms included tooth or/and gums for acute pericoronitis, ulcer for recurrent aphthous stomatitis and herpes for recurrent herpes simplex labialis. Each symptom was assessed by the Visual Analogue Scale（VAS），where a higher score meant higher severity.
次要结局
- The proportion of patients whose Intense-Exuberant Stomach Fire Syndrome were disappeared(Day 0,Day 5)
- Change from baseline of each symptom in Intense-Exuberant Stomach Fire Syndrome scores(Day 0,Day 3,Day 5)
- Change from baseline on toothache based on visual analogue scale(VAS)for acute pericoronitis(Day 0,Day 1,Day 2,Day 3,Day 4,Day 5)
- The proportion of patients who gain 50% reduction of Intense-Exuberant Stomach Fire Syndrome scores(Day 0,Day 5)
- Change from baseline on maximum mouth opening (MMO) for acute pericoronitis(Day 0,Day 3,Day 5)
- Number of patients with trismu for acute pericoronitis(Day 0,Day 3,Day 5)
- Change from baseline of VAS on the pain of ulcer for minor recurrent aphthous stomatitis(Day 0,Day 1,Day 2,Day 3,Day 4,Day 5)
- The sizes of ulcer for minor recurrent aphthous stomatitis(Day 0,Day 3,Day 5)
- Change from baseline on OHIP-14 measures for acute pericoronitis(Day 0,Day 3,Day 5)
- The proportion of patients with ulcer healing for minor recurrent aphthous stomatitis(Day 0,Day 3,Day 5)
- The number of days that the lesion was present (until loss of crust)for recurrent herpes simplex labialis(From the date of lesion or premonitory symptom present until the date of crust lose, which up to 28 days.)
- The proportion of patients with lesion healing for recurrent herpes simplex labialis(Day 3,Day 5)
- Change from baseline of VAS on the pain of lesions for recurrent herpes simplex labialis(Day 0,Day 1,Day 2,Day 3,Day 4,Day 5)
研究者
Zhong Wang
Chief
China Academy of Chinese Medical Sciences