Effectiveness and Clinical Mechanism of Huanglian-Jiedu Decoction in Patients With Intense-exuberant Stomach Fire Syndrome
1 other identifier
interventional
240
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2018
Shorter than P25 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2018
CompletedFirst Posted
Study publicly available on registry
March 19, 2018
CompletedStudy Start
First participant enrolled
April 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedApril 10, 2018
March 1, 2018
5 months
February 28, 2018
April 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change 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.
Day 0,Day 3,Day 5
Secondary Outcomes (13)
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 proportion of patients who gain 50% reduction of Intense-Exuberant Stomach Fire Syndrome scores
Day 0,Day 5
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
Change from baseline on maximum mouth opening (MMO) for acute pericoronitis
Day 0,Day 3,Day 5
- +8 more secondary outcomes
Other Outcomes (10)
High-sensitivity C-reactive protein（hs-CRP）
Day 0,Day 5
Evaluation of inflammatory cytokines
Day 0,Day 5
Activity of sirtuins (SIRTs)
Day 0,Day 5
- +7 more other outcomes
Study Arms (3)
Huanglian-Jiedu Decoction in acute pericoronitis
EXPERIMENTALAll 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 in recurrent aphthous stomatitis
EXPERIMENTALAll 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 in recurrent herpes simplex labialis
EXPERIMENTALAll eligible patients entering this group will receive Huanglian-Jiedu Decoction(prepared as granule). 1 bag per time and twice a day for 5 days.
Interventions
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
You may qualify if:
- 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 acute pericoronitis and without treatment before the study began.
- 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.
- History of recurrent herpes labialis averaging 1 or more episodes per year.
- Onset of prodrome, erythema or vesicle within 48 hours without treatment.
You may not qualify if:
- 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.
- 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.
- Patients with periodontal disease in the region of the acute pericoronitis.
- Patients who had systemic administration of antibiotics within the past 4 weeks
- Patients with history of drug abuse within the past 6 months.
- Patients who smoked at least 20 cigarettes per day（heavy smokers）.
- Patients with ulcers as a manifestation of a systemic disease process such as ulcerative colitis, Behcet's syndrome, Reiter' s syndrome or immune deficiency.
- 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.
- Patients who had orthodontic braces or retainer that might contact with the ulcer.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Third affiliated hospital of Beijing University of traditional Chinese medicine
Beijing, Beijing Municipality, 100029, China
Dongfang Hospital Affiliated to Beijing University of traditional Chinese medicine
Beijing, Beijing Municipality, 100078, China
Affiliated Hospital to Chengdu University of traditional Chinese medicine
Chengdu, Sichuan, 610075, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhong Wang
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief
Study Record Dates
First Submitted
February 28, 2018
First Posted
March 19, 2018
Study Start
April 4, 2018
Primary Completion
September 1, 2018
Study Completion
November 1, 2018
Last Updated
April 10, 2018
Record last verified: 2018-03