A Phase 1/2 interventional study of Huanglian-Jiedu Decoction in Intense-exuberant Stomach Fire Syndrom, Acute Pericoronitis and Recurrent Aphthous Stomatitis, sponsored by China Academy of Chinese Medical Sciences. Status unknown at 3 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-04-10.
Sponsored by China Academy of Chinese Medical Sciences · Phase 1/2, Interventional, and Treatment
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.
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.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's planned enrollment of 240 is above the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →China Academy of Chinese Medical Sciences is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
General inclusion criteria:
Disease-specific inclusion criteria for patients with acute pericoronitis:
Disease-specific inclusion criteria for patients with minor recurrent aphthous stomatitis:
Disease-specific inclusion criteria for recurrent herpes simplex labialis
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Huanglian-Jiedu Decoction
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.
Drug: Huanglian-Jiedu Decoction
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.
Drug: 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.
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.
Time frame: Day 0,Day 3,Day 5
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
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%
Time frame: 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%.
Time frame: 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.
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
To measure the amount of MMO, the inter-incisal distance between maxillary and mandibular right central incisors was recorded using a caliper.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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
Patients were asked to record the VAS each morning for 5 consecutive days prior to taking their medication.
Time frame: Day 0,Day 1,Day 2,Day 3,Day 4,Day 5
High-sensitivity C-reactive protein（hs-CRP）
Time frame: Day 0,Day 5
Evaluation of inflammatory cytokines
The evaluation of inflammatory cytokines include IL-1α, IL-1β, IL-4, IL-6, IL-8, IL-10, IL-13, MIP-2, MCP-1, IFNγand TNF-α
Time frame: Day 0,Day 5
Activity of sirtuins (SIRTs)
Detection by qRT-PCR
Time frame: Day 0,Day 5
GSH/GSSG ratios in plasma
Time frame: Day 0,Day 5
Evaluation of oxidative stress parameters：SOD
Time frame: Day 0,Day 5
Evaluation of oxidative stress parameters：MDA
Time frame: Day 0,Day 5
Pyruvate Acid / Uric Acid ratios in plasma
Time frame: Day 0,Day 5
Mass Spectrometry analyses for urine sample
Mass Spectrometry analyses for urine sample include hypoxanthine, 1.7 - diphosphate sedoheptose, -5- riboflavin phosphate, urobilin, D - Ribose, ubiquinone, urinary lactate / pyruvate urine
Time frame: Day 0,Day 5
Proteomic analyses for blood sample
Time frame: Day 0,Day 5
Proteomic analyses for urine sample
Time frame: Day 0,Day 5
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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China Academy of Chinese Medical Sciences