Efficacy and safety of Honghua Xiaoyao tablets in the treatment of premenstrual syndrome (liver depression and qi stagnation syndrome): a multicenter, randomized, placebo-controlled clinical trial

Efficacy and safety of Honghua Xiaoyao tablets in the treatment of premenstrual syndrome (liver depression and qi stagnation syndrome): a multicenter, randomized, placebo-controlled clinical trial - a clinical trial of Honghua Xiaoyao tablets in the treatment of premenstrual syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300079127

Enrollment

Unknown

Registered

2023-12-26

Start date

2023-12-31

Completion date

Unknown

Last updated

2024-01-08

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

Conditions

premenstrual syndrome

Interventions

experimental group:Honghua Xiaoyao tablets

control group:Honghua Xiaoyao Tablet Simulator

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.18 years <= age < 45 years;2.Those who meet the diagnostic criteria of PMS western medicine;3.Those who meet the diagnostic criteria of liver depression and qi stagnation syndrome in traditional Chinese medicine;4.The patient gave informed consent and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Those who are allergic to the drug components in the known test drug;2.Those who are using medication and other measures to treat premenstrual syndrome;3.Irregular menstrual cycle (menstrual cycle not within 28 ± 7 days);4.Subjects who are using hormonal contraceptives (including oral and subcutaneous implants);5.Premenstrual syndrome screening tool (PSST) score72, severe depression, and/or Self Rating Anxiety Scale (SAS) score>69, severe anxiety; 7.Individuals with severe diseases of cardiovascular, cerebrovascular, hematopoietic system, liver and kidney organs (serum transaminase levels above 1.5 times the upper limit of normal, serum creatinine above the upper limit of normal) and malignant tumors;8.regnant women, lactating women, or those who have a pregnancy plan within 6 months; 9.Individuals with mental illness and alcohol or drug dependence; 10. According to the judgment of the researchers, other lesions that reduce the likelihood of enrollment or complicate enrollment are not suitable for participation in this clinical study.

Design outcomes

Primary

Measure	Time frame
Symptom Severity Daily Record (DRSP) Premenstrual Total Points;	—

Secondary

Measure	Time frame
Symptom Severity Daily Record Form (DRSP) - Premenstrual physical, emotional, and behavioral symptom scores, as well as individual indicator scores;Traditional Chinese Medicine Syndrome Score;Single symptom score;	—

Countries

China

Contacts

Public ContactRuihua Zhao

Guang'anmen Hospital China Academy of Chinese Medical Sciences

rhzh801@126.com+86 136 2102 1092

Outcome results

None listed

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