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Clinical effect of Zhongtong'an combined with methylcobalamin tablets in the treatment of burning mouth syndrome: a randomized controlled trial

Clinical effect of Zhongtong'an combined with methylcobalamin tablets in the treatment of burning mouth syndrome: a randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052704
Enrollment
Unknown
Registered
2021-11-03
Start date
2021-11-20
Completion date
Unknown
Last updated
2022-08-08

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

Conditions

burning mouth syndrome (BMS)

Interventions

Experimental group:Taking methylcobalamin tablets and Chinese patent medicine Zhongtong'an
Control group:Taking methylcobalamin tablets and a placebo

Sponsors

Affiliated Stomatological Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as BMS patients (visual analogue scale (VAS) value >=4) according to the medical history and clinical examination; 2. Aged 18-60 years; 3. Blood routine, liver and kidney function, and fasting blood sugar are basically normal; 4. The patient did not receive other drug treatment other than the regimen during treatment; 5. Patients participate voluntarily, sign informed consent and provide personal medical history, can participate in the trial on time and can complete the entire research steps, and can come to the hospital for regular follow-up visits as required and strictly follow the doctor's orders.

Exclusion criteria

Exclusion criteria: 1. Suffering from other confirmed oral mucosal diseases or periodontitis; 2. Patients during pregnancy and childbearing age; 3. Patients with severe systemic diseases (such as diabetes, osteoporosis, gastrointestinal bleeding) or tumors; 4. Patients with allergies or a history of drug allergies; 5. Those with a history of smoking, alcoholism, drug abuse, or drug addiction; 6. Diagnosed with mental illness; 7. Those who have participated in or are participating in other clinical trials within 1 month before screening.

Design outcomes

Primary

MeasureTime frame
pain;

Secondary

MeasureTime frame
numbness;quality of life;depression situation;

Countries

China

Contacts

Public ContactSun Chen

Affiliated Stomatological Hospital of Southwest Medical University

676067464@qq.com+86 18308310796

Outcome results

None listed

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