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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Huanglian-Jiedu Decoction includes 4 kinds of Chinese herbs as following: Huanglian (Rhizoma Coptidis), Huangbo (Cortex Phellodendri), Huangqin (Scutellaria baicalensis) and Zhizi (Scutellaria baicalensis). All of them were prepared as granule.
Third affiliated hospital of Beijing University of traditional Chinese medicine
Beijing, Beijing Municipality, China
RECRUITINGDongfang Hospital Affiliated to Beijing University of traditional Chinese medicine
Beijing, Beijing Municipality, China
RECRUITINGAffiliated Hospital to Chengdu University of traditional Chinese medicine
Chengdu, Sichuan, China
RECRUITINGChange from baseline in the Intense-Exuberant Stomach Fire Syndrome scores
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.
Time frame: Day 0,Day 3,Day 5
Change from baseline of each symptom in Intense-Exuberant Stomach Fire Syndrome scores
Time frame: Day 0,Day 3,Day 5
The proportion of patients whose Intense-Exuberant Stomach Fire Syndrome were disappeared
The definition of "disappeared" is the scores of all the symptoms in Intense-Exuberant Stomach Fire Syndrome were 0 or the reduction in rate of Intense-Exuberant Stomach Fire Syndrome scores more than 90%
Time frame: Day 0,Day 5
The proportion of patients who gain 50% reduction of Intense-Exuberant Stomach Fire Syndrome scores
Reduction in rate of Intense-Exuberant Stomach Fire Syndrome scores =(The score of Intense-Exuberant Stomach Fire Syndrome before treatment - the score of Intense-Exuberant Stomach Fire Syndrome after treatment)/ The score of Intense-Exuberant Stomach Fire Syndrome before treatment×100%.
Time frame: Day 0,Day 5
Change from baseline on toothache based on visual analogue scale(VAS)for acute pericoronitis
Patients were asked to record the VAS each morning for 5 consecutive days prior to taking their medication.
Time frame: Day 0,Day 1,Day 2,Day 3,Day 4,Day 5
Change from baseline on maximum mouth opening (MMO) for acute pericoronitis
To measure the amount of MMO, the inter-incisal distance between maxillary and mandibular right central incisors was recorded using a caliper.
Time frame: Day 0,Day 3,Day 5
Number of patients with trismu for acute pericoronitis
Patients were recorded to have trismus if the MMO was less than 40 mm.
Time frame: Day 0,Day 3,Day 5
Change from baseline on OHIP-14 measures for acute pericoronitis
Using the OHIP measures, the patients were asked to rate the impact of their oral health on 14 key areas of OHRQoL: "What effects do your teeth, gums, and/or mouth have on each of the 14 key areas of life quality (i.e., your comfort, your speech)?" These 14 items were subdivided into seven domains (subscales): functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicap. For the OHIP-14, the response categories were recorded on a five-point Likert scale: 0, never; 1, hardly ever; 2, occasionally; 3, fairly often; 4, very often. Higher scores in the OHIP-14 questionnaire indicated a poorer OHQoL.
Time frame: Day 0,Day 3,Day 5
Change from baseline of VAS on the pain of ulcer for minor recurrent aphthous stomatitis
Patients were asked to record the VAS each morning for 5 consecutive days prior to taking their medication.
Time frame: Day 0,Day 1,Day 2,Day 3,Day 4,Day 5
The proportion of patients with ulcer healing for minor recurrent aphthous stomatitis
Time frame: Day 0,Day 3,Day 5
The sizes of ulcer for minor recurrent aphthous stomatitis
The investigators chose one of the largest ulcer and measured the maximum diameters and its vertical using a calibrated dental probe with millimeter markings. The two measurements were then multiplied to represent the size of the ulcer.
Time frame: Day 0,Day 3,Day 5
The number of days that the lesion was present (until loss of crust)for recurrent herpes simplex labialis
Time frame: 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
Time frame: Day 3,Day 5
Change from baseline of VAS on the pain of lesions for recurrent herpes simplex labialis
Patients were asked to record the VAS each morning for 5 consecutive days prior to taking their medication.
Time frame: Day 0,Day 1,Day 2,Day 3,Day 4,Day 5
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