mild recurrent aphthae ulcer (RA-Syndrome of accumulation of heat in the stomach and intestine)
Conditions
Interventions
Low dose group:Ice lotus grass buccaltablets.1 buccaltablets,tid-qd
High dose group:Ice lotus grass buccaltablets.2 buccaltablets,tid-qd
Placebo group:Simulation of ice lotus grassbuccaltablets. 1 buccaltablets,tid-qd
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Agree to participate in the clinical trial and sign the informed consent form; 2. Male or Female aged 18-65 years old; 3. The patients tally with the diagnostic criteria of recurrent aphthous ulcer and clinical classification with light-duty; 4. In accordance with the TCM diagnostic criteria of recurrent aphthous ulcer-gastrointestinal heat accumulation syndrome differentiation of, TCM syndrome score= 10 points; 5. The patients with ulcer occurred within 48 hours, VAS pain score =3 points, without any treatment.
Exclusion criteria
Exclusion criteria: 1. Known or suspected to have allergic history or serious adverse reaction to test drug and its accessories, or allergic constitution patients; 2. Severe aphthous ulcer, herpetiform aphthous ulcer, acute herpetic gingival stomatitis, traumatic ulcer, cancerous ulcer, tuberculosis ulcer, syphintic ulcer, necrotizing sialometaplasid, Behcet diseaseand ulcers caused byother diseases or drugs; 3. Patients with upper respiratory tract infection; 4. The ulcer is in areas such as the glossodesmus and Post pharyngeal, et al, and hard to measure the size; 5. With obvious oral pain which may affect the Curative Effect observation, such as pericoronitis, acute pulpitis,acuteapicitis et.al; 6. Taking analgesics and vitamins within 24 hours, antibiotics in 1 months, and corticosteroid hormone and immunomodulator in 3 months; 7. With active peptic ulcer; 8. With severe liver and kidney disease, or abnormal liver function tests (ALT, AST =1.5 times upper the limit of normal, Scr>the upper limit of normal); 9. With severe heart and lung disease, uncontrolled diabetes (random blood glucose = 11.1mmol/L), later period cancer, blood and hematopoietic system diseases, or serious or progressive diseases in other system; 10. Unable or unwilling to cooperate because of neurological and psychiatric disorders; 11. Have or be suspected having alcohol or drug abuse history; 12. Smoking > 20 cigarettes per day in the past 3 months; 13. Pregnancy, lactating women or fertility planner in recently; 14. Others which investigator considers are not suitable for the study; 15. Participated in other clinical trials within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The healing rate of target ulcer at the end of medication after 3 days and end of medication;The change of target ulcer area compared with baseline at the end of medication after 3 days and end of medication;The change of pain index compared with baseline at the at the end of medication after 3 days and end of medication; | — |
Countries
China
Contacts
Public ContactZhang Xing
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed