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Randomized, double-blind, positive drug parallel control, multi-center Chinese medicine variety protection clinical trial on the efficacy and safety of Baihe Gujin tablet in the treatment of chronic pharyngitis (lung-kidney yin deficiency syndrome)

Randomized, double-blind, positive drug parallel control, multi-center Chinese medicine variety protection clinical trial on the efficacy and safety of Baihe Gujin tablet in the treatment of chronic pharyngitis (lung-kidney yin deficiency syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2200006022
Enrollment
Unknown
Registered
2022-05-20
Start date
2022-05-09
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

chronic pharyngitis

Interventions

control group :Lily Gujin Tablet Simulator + Pharyngitis Tablets
test group :Lily Gujin Tablets + Pharyngitis Tablets Simulator

Sponsors

Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for chronic pharyngitis; (2) Comply with the standard of TCM syndrome differentiation of lung and kidney yin deficiency; (3) Age 18 to 65 years old (including 18 and 65 years old), gender is not limited; (4) Subjects gave informed consent, voluntarily tested and signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Pharyngeal paraesthesia caused by chronic tonsillitis, styloid process syndrome, hyoid syndrome or other pharyngeal diseases, reflux esophagitis, bronchitis, early esophageal cancer, etc.; (2) ALT and/or AST >1.5 upper limit of normal reference value; serum creatinine > upper limit of normal reference value; blood leukocyte 10.0×109/L; and/or neutrophil (N) classification >80%; body temperature =37.3?; (3) Patients who smoked or quit smoking for less than three months; or unavoidably exposed to dust or harmful gas for a long time; (4) Those who have used drugs, non-drug treatments or health products that have a therapeutic effect on chronic pharyngitis within 1 week; or who have received pharyngeal surgery within 6 months; (5) Combined with serious primary diseases of cardiovascular and cerebrovascular, liver, kidney, respiratory system, circulatory system, autoimmune system and hematopoietic system, or serious diseases that affect their survival, such as tumor or AIDS; of disabled patients; (6) A history of alcohol and drug abuse or drug use in the past year; (7) Pregnant or lactating women or those who are unwilling to take contraceptive measures during the test and within 1 month after the end of the test; (8) Participated in another drug study within three months prior to enrollment; (9) Those with allergic constitution or known ingredients of the drug; (10)The investigators determined that there were other factors that were inappropriate for enrollment.

Design outcomes

Primary

MeasureTime frame
clinical efficacy;

Secondary

MeasureTime frame
Efficacy of a single clinical symptom;Therapeutic effects of TCM syndromes;

Countries

China

Contacts

Public Contactjunge.Wang
wjgent@163.com18901176299

Outcome results

None listed

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