Effectiveness and Clinical Mechanism of Huanglian-Jiedu Decoction in Patients With Intense-exuber… (NCT03469232) | Clinical Trial Compass
UnknownPhase 1/2
Effectiveness and Clinical Mechanism of Huanglian-Jiedu Decoction in Patients With Intense-exuberant Stomach Fire Syndrome
China240 participantsStarted 2018-04-04
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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.
✓. 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.
✓. Patients with clinical diagnosis of recurrent herpes simplex labialis.
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.
What they're measuring
1
Change from baseline in the Intense-Exuberant Stomach Fire Syndrome scores
✕. 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.
✕. Patients who smoked at least 20 cigarettes per day（heavy smokers）.
✕. Patients with fascial space infection of maxillofacial region or/and chronic periodontitis.