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Clinical Study on Zishui Bugan Decoction in Treating Insomnia of Liver-Kidney Deficiency in Menopause

Clinical Study on Zishui Bugan Decoction in Treating Insomnia of Liver-Kidney Deficiency in Menopause

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046155
Enrollment
Unknown
Registered
2021-05-06
Start date
2019-12-01
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

Insomnia

Interventions

Sponsors

Chongqing Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.The age of the patient is between 40 and 60 years old (including 40 years old and 60 years old); 2.Meet the diagnostic criteria of traditional Chinese and Western medicine for perimenopausal insomnia and the diagnostic criteria of TCM syndromes for liver and kidney yin deficiency; 3.Improved Kupperman scale > 5 points, Pittsburgh Sleep Quality Index (PSQI)> 7 points; 4.No sedatives and hypnotic drugs were taken at the time of enrollment, and no related non-drug treatments, such as cognitive behavioral therapy, music therapy, etc.; those who had taken sedatives and hypnotic drugs were enrolled after a 7-day washout period in advance; 5.Participants sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients under the age of 40 and over 60 years; 2.People with insomnia before the age of 40; 3.Insomnia caused by various diseases, environmental changes, and major changes; 4.Alcoholism and/or psychoactive drugs, drug abusers and dependents, as well as those who cannot stop taking Chinese medicines and sedative western medicines; 5.Estrogen replacement therapy; 6.Those who are allergic to the known ingredients of this medicine; 7.Combined with serious heart, brain, kidney, liver and other diseases.

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality index;Modified Kupperman Index;Liver and Kidney Yin Deficiency TCM Scale;

Countries

China

Contacts

Public ContactChen Jing

Chongqing Traditional Chinese Medicine Hospital

63241013@qq.com+86 19923279668

Outcome results

None listed

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