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A randomized, double-blind, placebo-controlled, multi-center clinical study of FuFangYuXingCaoHeJi in the treatment of sore throat with wind-heat syndrome

A randomized, double-blind, placebo-controlled, multi-center clinical study of FuFangYuXingCaoHeJi in the treatment of sore throat with wind-heat syndrome

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053105
Enrollment
Unknown
Registered
2021-11-10
Start date
2021-11-15
Completion date
Unknown
Last updated
2022-09-06

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

Conditions

Sore throat

Interventions

Experimental group:FuFangYuXingCaoHeJi
Control group:The placebo of FuFangYuXingCaoHeJi

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 75 years old (including 18 and 75 years old), regardless of gender; 2.Meet the diagnostic criteria of Western medicine for acute pharyngitis / acute tonsillitis; 3.It meets the syndrome differentiation standard of exogenous wind heat syndrome in traditional Chinese medicine; 4.Acute onset, the course of disease shall not exceed 48 hours; 5.VAS score of pharyngeal pain >= 4.0; 6.The subjects understood and voluntarily participated in the experiment, and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Positive results of New Coronavirus pneumonia nucleic acid test results; 2.Body temperature (axillary) above 38.5 ?; 3.Pharyngeal symptoms or inflammation caused by measles, scarlet fever, influenza, infectious mononucleosis, agranulocytosis, leukemia, etc.; 4.Accompanied by pneumonia and bronchitis, suppurative tonsillitis; 5.Combined with severe primary diseases such as cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system, or severe diseases that affect their survival, such as tumors or AIDS; 6.ALT and AST > 1.5 times the upper limit of normal reference value, Scr > the upper limit of normal reference value; 7.Total white blood cell (WBC) > 12 x 10^9 / L or neutrophil percentage (NEUT) > 1.2 times the upper limit of normal reference value; 8.Any medicine used to treat acute pharyngitis, such as antibiotics, glucocorticoids or non steroids, as well as similar traditional Chinese medicine for the treatment of this disease; 9.Diabetes mellitus; 10.Other diseases with previous history of glomerulonephritis or acute pharyngitis and tonsillitis that can induce the primary disease or aggravate the risk; 11.Pregnant, pregnant or lactating women, and women of childbearing age who cannot take reasonable contraceptive measures during the study period; 12.Patients who have a history of allergy to the components of the test drug; 13.Psychiatric patients; 14.Those who have participated in clinical trials of other drugs in recent 3 months; 15.Due to other reasons, the researcher believes that it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Rate of disappearance of sore throat;

Secondary

MeasureTime frame
Time of disappearance of pharyngalgia;Relief degree of pharyngeal pain;Traditional Chinese medicine syndrome score;Frequency and dose of antipyretic analgesics;Direct medical cost;Indirect Medical Cost;Cost of adverse drug reactions;

Countries

China

Contacts

Public ContactZhang Hongchun

China-Japan Friendship Hospital

13701226664@139.com+86 13701226664

Outcome results

None listed

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