Effectiveness and Clinical Mechanism of Huanglian-Jiedu Decoction in Patients With Intense-exuberant Stomach Fire Syndrome

China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Recurrent Herpes Simplex Labialis; Intense-exuberant Stomach Fire Syndrom; Acute Pericoronitis; Recurrent Aphthous Stomatitis

Treatments: Drug: Huanglian-Jiedu Decoction

Study type: Interventional

Funder types: Other

Identifiers

NCT03469232

HLJD-V3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

Huanglian-Jiedu Decoction in acute pericoronitis

Experimental group

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.

Treatment:

Drug: Huanglian-Jiedu Decoction

Huanglian-Jiedu Decoction in recurrent aphthous stomatitis

Experimental group

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.

Treatment:

Drug: Huanglian-Jiedu Decoction

Huanglian-Jiedu Decoction in recurrent herpes simplex labialis

Experimental group

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.

Treatment:

Drug: Huanglian-Jiedu Decoction