Intense-exuberant Stomach Fire SyndromPhase 1/2NCT03469232
Effectiveness and Clinical Mechanism of Huanglian-Jiedu Decoction in Patients With Intense-exuberant Stomach Fire Syndrome
A Phase 1/2 study testing Huanglian-Jiedu Decoction in people with Intense-exuberant Stomach Fire Syndrom and Acute Pericoronitis, run by China Academy of Chinese Medical Sciences at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intense-exuberant Stomach Fire Syndrom, Acute Pericoronitis, Recurrent Aphthous Stomatitis
- What is being tested?
- Huanglian-Jiedu Decoction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesChina
- Study dates
- 4 Apr 2018to 1 Nov 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- General 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.
- Disease-specific inclusion criteria for patients with acute pericoronitis:
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- 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:
- 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.
- Disease-specific inclusion criteria for recurrent herpes simplex labialis
- 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.
Who cannot join
- General 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.
- 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.
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- Patients who are considered unreliable as to medication compliance or adherence to scheduled appointments.
- Disease-specific exclusion criteria for acute pericoronitis:
- 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
- Disease-specific exclusion criteria for minor recurrent aphthous stomatitis(MiRAS):
- 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.
- Disease-specific exclusion criteria for recurrent herpes simplex labialis:
- Patients with fever > 38.5℃, and / or blood WBC>11.0x109/L, and / or neutrophil >85%.
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Third affiliated hospital of Beijing University of traditional Chinese medicine
Beijing, Beijing Municipality, 100029
Lu Qiang, Professor, 8610-52075325
Lu Qiang, Professor
- Recruiting
Dongfang Hospital Affiliated to Beijing University of traditional Chinese medicine
Beijing, Beijing Municipality, 100078
Hong Mu, Professor, 010-67618333
Hong Mu, Professor
- Recruiting
Affiliated Hospital to Chengdu University of traditional Chinese medicine
Chengdu, Sichuan, 610075
Yuling Zuo, Professor, 028-87769902
Yuling Zuo, Professor
About this study
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)
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.
Read the 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.
- Conditions
- Intense-exuberant Stomach Fire Syndrom, Acute Pericoronitis, Recurrent Aphthous Stomatitis, Recurrent Herpes Simplex Labialis
- Being tested
- Huanglian-Jiedu Decoction
- Medical subject headings
- Stomatitis, Aphthous, Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huanglian-Jiedu DecoctionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Huanglian-Jiedu Decoction in acute pericoronitis | Experimental | 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. Receives: Drug: Huanglian-Jiedu Decoction |
| Huanglian-Jiedu Decoction in recurrent aphthous stomatitis | Experimental | 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. Receives: Drug: Huanglian-Jiedu Decoction |
| Huanglian-Jiedu Decoction in recurrent herpes simplex labialis | Experimental | 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. Receives: Drug: Huanglian-Jiedu Decoction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0,Day 3,Day 5
Secondary outcomes (13)
Change from baseline of each symptom in Intense-Exuberant Stomach Fire Syndrome scores
Measured: Day 0,Day 3,Day 5
The proportion of patients whose Intense-Exuberant Stomach Fire Syndrome were disappeared
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%
Measured: Day 0,Day 5
The proportion of patients who gain 50% reduction of Intense-Exuberant Stomach Fire Syndrome scores
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%.
Measured: Day 0,Day 5
Change from baseline on toothache based on visual analogue scale(VAS)for acute pericoronitis
Patients were asked to record the VAS each morning for 5 consecutive days prior to taking their medication.
Measured: Day 0,Day 1,Day 2,Day 3,Day 4,Day 5
Change from baseline on maximum mouth opening (MMO) for acute pericoronitis
To measure the amount of MMO, the inter-incisal distance between maxillary and mandibular right central incisors was recorded using a caliper.
Measured: Day 0,Day 3,Day 5
Number of patients with trismu for acute pericoronitis
Patients were recorded to have trismus if the MMO was less than 40 mm.
Measured: Day 0,Day 3,Day 5
Change from baseline on OHIP-14 measures for acute pericoronitis
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.
Measured: Day 0,Day 3,Day 5
Change from baseline of VAS on the pain of ulcer for minor recurrent aphthous stomatitis
Patients were asked to record the VAS each morning for 5 consecutive days prior to taking their medication.
Measured: Day 0,Day 1,Day 2,Day 3,Day 4,Day 5
The proportion of patients with ulcer healing for minor recurrent aphthous stomatitis
Measured: Day 0,Day 3,Day 5
The sizes of ulcer for minor recurrent aphthous stomatitis
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.
Measured: Day 0,Day 3,Day 5
The number of days that the lesion was present (until loss of crust)for recurrent herpes simplex labialis
Measured: 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
Measured: Day 3,Day 5
Change from baseline of VAS on the pain of lesions for recurrent herpes simplex labialis
Patients were asked to record the VAS each morning for 5 consecutive days prior to taking their medication.
Measured: Day 0,Day 1,Day 2,Day 3,Day 4,Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start4 Apr 2018
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intense-exuberant Stomach Fire SyndromStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhong Wang, China Academy of Chinese Medical Sciences
- Investigators
- Zhong Wang, Principal investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469232
- Sponsor's protocol ID
- HLJD-V3
- Status last verified
- Mar 2018
- First submitted
- 28 Feb 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03469232
- Acronym / sponsor ID
- HLJD-V3
- Conditions
- Intense-exuberant Stomach Fire Syndrom, Acute Pericoronitis, Recurrent Aphthous Stomatitis, Recurrent Herpes Simplex Labialis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Huanglian-Jiedu Decoction in acute pericoronitis | Experimental | Drug: Huanglian-Jiedu DecoctionAll 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 | Experimental | Drug: Huanglian-Jiedu DecoctionAll 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 | Experimental | Drug: Huanglian-Jiedu DecoctionAll eligible patients entering this group will receive Huanglian-Jiedu Decoction(prepared as granule). 1 bag per time and twice a day for 5 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- General inclusion criteria:
- 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:
- Disease-specific inclusion criteria for recurrent herpes simplex labialis
Key exclusion criteria (21 listed)
- General exclusion criteria:
- Disease-specific exclusion criteria for acute pericoronitis:
- Disease-specific exclusion criteria for minor recurrent aphthous stomatitis(MiRAS):
- Disease-specific exclusion criteria for recurrent herpes simplex labialis:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huanglian-Jiedu DecoctionHuanglian-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. | Drug | Huanglian-Jiedu Decoction in acute pericoronitis, Huanglian-Jiedu Decoction in recurrent aphthous stomatitis, Huanglian-Jiedu Decoction in recurrent herpes simplex labialis |
Primary outcome
Change from baseline in the Intense-Exuberant Stomach Fire Syndrome scores
Time frame: 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.
13 secondary outcomes
Change from baseline of each symptom in Intense-Exuberant Stomach Fire Syndrome scores
Time frame: Day 0,Day 3,Day 5
The proportion of patients whose Intense-Exuberant Stomach Fire Syndrome were disappeared
Time frame: Day 0,Day 5
The proportion of patients who gain 50% reduction of Intense-Exuberant Stomach Fire Syndrome scores
Time frame: Day 0,Day 5
Change from baseline on toothache based on visual analogue scale(VAS)for acute pericoronitis
Time frame: Day 0,Day 1,Day 2,Day 3,Day 4,Day 5
Change from baseline on maximum mouth opening (MMO) for acute pericoronitis
Time frame: Day 0,Day 3,Day 5
Number of patients with trismu for acute pericoronitis
Time frame: Day 0,Day 3,Day 5
Change from baseline on OHIP-14 measures for acute pericoronitis
Time frame: Day 0,Day 3,Day 5
Change from baseline of VAS on the pain of ulcer for minor recurrent aphthous stomatitis
Time frame: Day 0,Day 1,Day 2,Day 3,Day 4,Day 5
The proportion of patients with ulcer healing for minor recurrent aphthous stomatitis
Time frame: Day 0,Day 3,Day 5
The sizes of ulcer for minor recurrent aphthous stomatitis
Time frame: Day 0,Day 3,Day 5
The number of days that the lesion was present (until loss of crust)for recurrent herpes simplex labialis
Time frame: 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
Time frame: Day 3,Day 5
Change from baseline of VAS on the pain of lesions for recurrent herpes simplex labialis
Time frame: Day 0,Day 1,Day 2,Day 3,Day 4,Day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhong Wang principal investigator
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Huanglian-Jiedu Decoction in people with Intense-exuberant Stomach Fire Syndrom and Acute Pericoronitis, run by China Academy of Chinese Medical Sciences at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanan Yu, Ph.D (8610-64093140, pumpkinnaicha@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Intense-Exuberant Stomach Fire Syndrome scores (time frame: Day 0,Day 3,Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.