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A randomized controlled trial for Xuefu Zhuyu Decoction in the treatment of qi deficiency and blood stasis type burning mouth snydrome with cerebral blood perfusion abnormality

A randomized controlled trial for Xuefu Zhuyu Decoction in the treatment of qi deficiency and blood stasis type burning mouth snydrome with cerebral blood perfusion abnormality

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026715
Enrollment
Unknown
Registered
2019-10-19
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-10-21

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

Conditions

Burning Mouth Snydrome

Interventions

Group A:Adenosine cobalamin tablets (Chinese medicine quasi-word H13020514), 0.25mg, 3 capsules each time, 3 times a day, orally for 12 weeks.
Group B:Angelica 9 g, raw land 9 g, peach kernel 12 g, safflower 9 g, oyster shell 6 g, red peony 6 g, bupleurum 3 g, licorice 3 g, platycodon 4.5 g, Chuanxiong 4.5 g, Achyranthes 10 g. Decoction with
Group C:combination treatment of adenosine cobalamin tablets and Xuefu Zhuyu for 12 weeks.

Sponsors

Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Those who can read and understand the informed consent form and be willing to attending the trial; 2) Male and female aged 18 to 75 years old; 3) Qi deficiency and blood stasis type BMS criteria: BMS was diagnosed according to medical history and clinical symptom, and qi deficiency and blood stasis type were selected by clinical classification, and VAS pain score was assessed; 4) rCBF abnormal criteria: diagnosed by SPECT/CT examination; 5) Those with a constant treatment plan and good compliance.

Exclusion criteria

Exclusion criteria: 1) Those who are diagnosed as other oral mucosal diseases; 2) Those are with unstable, severe, or acutely progressive liver or kidney diseases, such as ALT or AST > 2 times the upper limit of normal, BUN > 1.5 times the upper limit of normal, creatinine > 1.5 times the upper limit of normal; 3) Those who have used antibiotics within 1 month and immunologic preparations within 3 months; 4) Those are with severe and uncontrolled systemic diseases such as hematological diseases, severe neurological damage, ventricular dysfunction with or with a history of congestive heart failure, or any condition that may affects the study treatment and outcome evaluate or fail to ensure completion of the study; 5) Those who are pregnant or nursing; 6) Those who can not tolerate the designed treatment; 7) Expected survival period <3 months; 8) Those with alcoholism, drug dependence, and any subject may be affact the completion of the study judged by the investigator; 9) Those with any clinically significant abnormal results through physical examination or electrocardiogram examination, which may affect the completion of this clinical study and the safety of the participants ; 10) Those who are allergic to medicine used in the treatment.

Design outcomes

Primary

MeasureTime frame
rCBF anomaly value;

Secondary

MeasureTime frame
BMS symptom score;

Countries

China

Contacts

Public ContactLan Wu

Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiaotong University School of Medicine

teana_wu@sina.com+86 13818169807

Outcome results

None listed

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