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

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Brief Title

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

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)

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.
    

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 Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Change from baseline in the Intense-Exuberant Stomach Fire Syndrome scores

Secondary Outcome

 Change from baseline of each symptom in Intense-Exuberant Stomach Fire Syndrome scores

Condition

Intense-exuberant Stomach Fire Syndrom

Intervention

Huanglian-Jiedu Decoction

Study Arms / Comparison Groups

 Huanglian-Jiedu Decoction in acute pericoronitis
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

240

Start Date

April 4, 2018

Completion Date

November 1, 2018

Primary Completion Date

September 1, 2018

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Zhong Wang, 8610-64093140, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03469232

Organization ID

HLJD-V3


Responsible Party

Principal Investigator

Study Sponsor

China Academy of Chinese Medical Sciences


Study Sponsor

Zhong Wang, Principal Investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences


Verification Date

March 2018