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Clinical study of Lianzhu Anshen prescription for the treatment of senile insomnia (heart and kidney non-exchange)

Clinical study of Lianzhu Anshen prescription for the treatment of senile insomnia (heart and kidney non-exchange)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025002108
Enrollment
Unknown
Registered
2025-11-04
Start date
2025-06-06
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

insomnia

Interventions

Exposure group:Lian Zhu An Shen Formula Modification+Conventional Western Medicine Treatment
Non-exposed group:Conventional treatment with Western medicine

Sponsors

Jiangsu Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Conform to the diagnostic criteria of heart-kidney disharmony insomnia and insomnia ; 2.Pittsburgh sleep index scale score > 7 ; 3. Aged 60 to 90 years ; 4.Gender is not limited to men and women ; 5.Volunteers who voluntarily signed informed consent ; 6.No other drug clinical trials were added.

Exclusion criteria

Exclusion criteria: 1.The working and living environment can not guarantee adequate sleep in a fixed place and opportunities ( bedtime at least 8h ) ; 2.belong to allergic constitution and allergic to a variety of drugs ; 3.Patients with severe primary diseases such as cardiovascular and cerebrovascular diseases lung liver kidney and hematopoietic system ; 4.In acute stress state : acute cardiovascular and cerebrovascular accidents severe trauma etc. ; 5.Taking other related drugs to treat insomnia ; 6.Patients with severe physical and mental diseases ( HAMD > 35 points HAMA > 29 points ) ; 7.There are obvious acute infectious diseases : such as upper and lower respiratory tract infection acute pancreatitis urinary tract infection. dyeing etc. ; 8.Discomfort to the treatment process there is a clear psychological rejection ; 9.Alcohol psychoactive drugs and other abuse or dependence.

Design outcomes

Primary

MeasureTime frame
Traditional Chinese Medicine syndrome score scale;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index;Hamilton Anxiety Scale;Hamilton Depression Scale;

Countries

China

Contacts

Public ContactWang Han

Jiangsu Provincial Hospital of Traditional Chinese Medicine

hanf2500@163.com13952004466

Outcome results

None listed

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