Brief Title
Effectiveness and Clinical Mechanism of Huanglian-Jiedu Decoction in Patients With Intense-exuberant Stomach Fire Syndrome
Official Title
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)
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Change from baseline in the Intense-Exuberant Stomach Fire Syndrome scores
Secondary Outcome
Change from baseline of each symptom in Intense-Exuberant Stomach Fire Syndrome scores
Condition
Intense-exuberant Stomach Fire Syndrom
Intervention
Huanglian-Jiedu Decoction
Study Arms / Comparison Groups
Huanglian-Jiedu Decoction in acute pericoronitis
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
240
Start Date
April 4, 2018
Completion Date
November 1, 2018
Primary Completion Date
September 1, 2018
Eligibility Criteria
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 exclusion criteria:
1. 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.
2. 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.
3. Women during pregnancy, lactation , breastfeeding or having child bearing
potential without use an adequate method of birth control.
4. 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 ).
5. Patients participating in or having participated in other clinical studies in the
3 months prior to this clinical trial.
6. Patients who are considered unreliable as to medication compliance or adherence
to scheduled appointments.
- Disease-specific exclusion criteria for acute pericoronitis:
1. Patients who smoked at least 20 cigarettes per day（heavy smokers）.
2. Patients with fascial space infection of maxillofacial region or/and chronic
periodontitis.
3. Patients with periodontal disease in the region of the acute pericoronitis.
4. Patients who had systemic administration of antibiotics within the past 4 weeks
- Disease-specific exclusion criteria for minor recurrent aphthous stomatitis(MiRAS):
1. Patients with history of drug abuse within the past 6 months.
2. Patients who smoked at least 20 cigarettes per day（heavy smokers）.
3. Patients with ulcers as a manifestation of a systemic disease process such as
ulcerative colitis, Behcet's syndrome, Reiter' s syndrome or immune deficiency.
4. 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.
5. Patients who had orthodontic braces or retainer that might contact with the
ulcer.
- Disease-specific exclusion criteria for recurrent herpes simplex labialis:
1. Patients with fever > 38.5℃, and / or blood WBC>11.0x109/L, and / or neutrophil
>85%.
2. 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.
Gender
All
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Zhong Wang, 8610-64093140, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03469232
Organization ID
HLJD-V3
Responsible Party
Principal Investigator
Study Sponsor
China Academy of Chinese Medical Sciences
Study Sponsor
Zhong Wang, Principal Investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Verification Date
March 2018