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Research on the Transformation Application of Ningkun Jieyu Decoction in the Treatment of Perimenopausal Anxiety Disorder

Research on the Transformation Application of Ningkun Jieyu Decoction in the Treatment of Perimenopausal Anxiety Disorder

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080171
Enrollment
Unknown
Registered
2024-01-22
Start date
2024-01-23
Completion date
Unknown
Last updated
2024-01-28

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

Conditions

Perimenopausal Anxiety Disorder

Interventions

the experimental group:Ningkun Jieyu Decoction
the control group:Femoston combined with Flupentixol and Melitracen Tablets

Sponsors

WANG JING HOSPITAL OF CACMS
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Meeting the diagnostic criteria of western medicine for perimenopausal syndrome and anxiety disorder; classified as liver depression and heat syndrome by Chinese Medicine syndrome differentiation; women aged 40 to 60; Kupperman scale score > 6 points, 7 points = Hamilton anxiety score 10 U/L. 3.In accordance with Liver depression and heat syndrome. 4.Patients receiving anti-anxiety drugs and hormone therapy had not taken them before entering the trial or had stopped taking them several months earlier. 5.Patients who voluntarily agree to participate in this study, have good compliance, cooperate with treatment and sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with bilateral ovariectomy, or ovarian tumors. 2.Patients with allergic constitution or allergy to traditional Chinese medicine. 3.Patients with severe primary diseases of cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems, as well as psychotic disorders such as severe depression and mania. 4.Patients with dementia, traumatic brain injury, intellectual disability, stroke, epilepsy and other neurological diseases. 5.Patients with dictation disorder who could not complete the scale assessment. 6.Patients who had participated or simultaneously participate in other clinical trial programs in the past 3 months. 7.Patients who had taken sex hormone drugs or drugs affecting sex hormone levels in the past month. 8.Patients who do not meet the inclusion criteria, or do not take the drug as prescribed, or withdraw voluntarily, or do not complete the indicators, or have serious adverse reactions during the study.

Design outcomes

Primary

MeasureTime frame
E2;FSH;LH;5-HT;DA;Kupperman;Greene;MENQOL;Hamilton Anxiety Scale;TCM syndrome score;

Secondary

MeasureTime frame
Blood routine ;Urine routine ;Liver and kidney function ;Electrocardiogram;Endometrial thickness;Vital signs;

Countries

China

Contacts

Public ContactWang Hao

WANG JING HOSPITAL OF CACMS

pgwanghao@126.com+86 135 8157 7090

Outcome results

None listed

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