Acute Pericoronitis, Intense-exuberant Stomach Fire Syndrom, Recurrent Aphthous Stomatitis, Recurrent Herpes Simplex Labialis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGHuanglian-Jiedu Decoction
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.
Sponsors
China Academy of Chinese Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* General inclusion criteria: 1. Female or male patients. 2. Age: 18 - 60 years. 3. Meeting the diagnostic criteria of Intense-Exuberant Stomach Fire Syndrome according to the traditional Chinese medicine. 4. Patient is willing to participate voluntarily and to sign a written patient informed consent. * Disease-specific inclusion criteria for patients with acute pericoronitis: 1\. 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: 1. Patients with clinical diagnosis of minor recurrent aphthous stomatitis(MiRAS). 2. 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. 3. Ulcer occurred less than 48h hours' duration without treatment. * Disease-specific inclusion criteria for recurrent herpes simplex labialis 1. Patients with clinical diagnosis of recurrent herpes simplex labialis. 2. History of recurrent herpes labialis averaging 1 or more episodes per year. 3. Onset of prodrome, erythema or vesicle within 48 hours without treatment.
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Intense-Exuberant Stomach Fire Syndrome scores | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients who gain 50% reduction of Intense-Exuberant Stomach Fire Syndrome scores | Day 0,Day 5 | 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%. |
| 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 | Patients were asked to record the VAS each morning for 5 consecutive days prior to taking their medication. |
| Change from baseline on maximum mouth opening (MMO) for acute pericoronitis | Day 0,Day 3,Day 5 | To measure the amount of MMO, the inter-incisal distance between maxillary and mandibular right central incisors was recorded using a caliper. |
| Number of patients with trismu for acute pericoronitis | Day 0,Day 3,Day 5 | Patients were recorded to have trismus if the MMO was less than 40 mm. |
| Change from baseline on OHIP-14 measures for acute pericoronitis | Day 0,Day 3,Day 5 | 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. |
| 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 | Patients were asked to record the VAS each morning for 5 consecutive days prior to taking their medication. |
| The proportion of patients with ulcer healing for minor recurrent aphthous stomatitis | Day 0,Day 3,Day 5 | — |
| The sizes of ulcer for minor recurrent aphthous stomatitis | Day 0,Day 3,Day 5 | 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. |
| 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 | Patients were asked to record the VAS each morning for 5 consecutive days prior to taking their medication. |
| Change from baseline of each symptom in Intense-Exuberant Stomach Fire Syndrome scores | Day 0,Day 3,Day 5 | — |
| The proportion of patients whose Intense-Exuberant Stomach Fire Syndrome were disappeared | Day 0,Day 5 | 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% |
Other
| Measure | Time frame | Description |
|---|---|---|
| Activity of sirtuins (SIRTs) | Day 0,Day 5 | Detection by qRT-PCR |
| GSH/GSSG ratios in plasma | Day 0,Day 5 | — |
| Evaluation of oxidative stress parameters：SOD | Day 0,Day 5 | — |
| Evaluation of oxidative stress parameters：MDA | Day 0,Day 5 | — |
| Pyruvate Acid / Uric Acid ratios in plasma | Day 0,Day 5 | — |
| Mass Spectrometry analyses for urine sample | Day 0,Day 5 | Mass Spectrometry analyses for urine sample include hypoxanthine, 1.7 - diphosphate sedoheptose, -5- riboflavin phosphate, urobilin, D - Ribose, ubiquinone, urinary lactate / pyruvate urine |
| Proteomic analyses for blood sample | Day 0,Day 5 | — |
| Proteomic analyses for urine sample | Day 0,Day 5 | — |
| High-sensitivity C-reactive protein（hs-CRP） | Day 0,Day 5 | — |
| Evaluation of inflammatory cytokines | Day 0,Day 5 | The evaluation of inflammatory cytokines include IL-1α, IL-1β, IL-4, IL-6, IL-8, IL-10, IL-13, MIP-2, MCP-1, IFNγand TNF-α |
Countries
China
Contacts
Primary ContactYanan Yu, Ph.D
Backup ContactZhong Wang, Professor
Outcome results
None listed