The efficacy and safety evaluation of Kouyanqing Granule in Herpetic stomatitis with Yin deficiency and Wind-heat syndrome: a multi-center, randomized, doubled-blind, placebo-controlled trial

The efficacy and safety evaluation of Kouyanqing Granule in Herpetic stomatitis with Yin deficiency and Wind-heat syndrome: a multi-center, randomized,doubled-blind, placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13003321

Enrollment

Unknown

Registered

2013-06-17

Start date

2013-08-17

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

herpetic stomatitis

Interventions

A:Kouyanqing Granule

B:Placebo Granule

Eligibility

Sex/Gender

All

Age

1 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. herpetic stomatitis diagnosed according to nationwide unified western medicine diagnostic criteria; 2. Meeting Yin deficiency wind heat syndrome in TCM diagnostic criteria; 3. Aged 1-6 years; 4. within 48 hours of the onset of illness; 5. Fully informed, voluntary consent, and signed the ICF by legal guardians.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. white blood cell count>12*10^9/L or neutrophilic granulocyte percentage >75%; 2. ALT or AST > 1.5 times the Upper limit of normal value scope; 3. Recurrent oral ulcer and systemic diseases related to oral ulcer; 4. Combined with Severe systemic disease such as cardiocerebral vascular system, endocrine system, Hematologic System, liver or kidney disease, etc; 5. Allergic constitution or allergic to drug used in this study; 6. Disabled patients who have blindness, deafness and mutism, dysgnosia or mental disturbance.

Design outcomes

Primary

Measure	Time frame
disappear time of oral ulce;	—

Secondary

Measure	Time frame
changes in pain on a visual analog scale;TCM syndrome curative effect;	—

Countries

China

Contacts

Public ContactSiyuan Hu

Tianjin University of Traditional Chinese Medicine

husiyuan1963@sina.com+86 13752009293

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026