Effectiveness and Clinical Mechanism of Huanglian-Jiedu Decoction in Patients With Intense-exuberant Stomach Fire Syndrome
NCT ID: NCT03469232
Last Updated: 2018-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
240 participants
INTERVENTIONAL
2018-04-04
2018-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Huanglian-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.
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.
Huanglian-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.
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.
Huanglian-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.
Interventions
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Huanglian-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.
Eligibility Criteria
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Inclusion Criteria
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.
1\. Patients with clinical diagnosis of acute pericoronitis and without treatment before the study began.
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.
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
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.
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
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.
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.
18 Years
60 Years
ALL
No
Sponsors
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China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Zhong Wang
Chief
Principal Investigators
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Zhong Wang
Role: PRINCIPAL_INVESTIGATOR
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Locations
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Third affiliated hospital of Beijing University of traditional Chinese medicine
Beijing, Beijing Municipality, China
Dongfang Hospital Affiliated to Beijing University of traditional Chinese medicine
Beijing, Beijing Municipality, China
Affiliated Hospital to Chengdu University of traditional Chinese medicine
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Lu Qiang, Professor
Role: primary
Hong Mu, Professor
Role: primary
Yuling Zuo, Professor
Role: primary
Other Identifiers
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HLJD-V3
Identifier Type: -
Identifier Source: org_study_id
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