Clinical study on the treatment of Perimenopausal Insomnia with Yishen Pinggan Decoctio

Phase 1

• Conditions: Perimenopausal Insomnia

• Registration Number: ITMCTR2000003635
• Lead Sponsor: Shanghai Municipal Hospital Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1.Women aged 45-60 years;
2.Insomnia;
3.Perimenopausal symptoms;
4.PSQI>= 6and KI>=15;
5.No sedatives and sleeping pills,or Stop taking sleeping pills more than two weeks.

Exclusion Criteria

1. Premature ovarian failure or bilateral ovariectomy due to other diseases;
2. With mental illness;
3. HAMA >= 14 and(or) HAMD >= 18;
4. Obvious symptoms of heart, liver, kidney or other systems;
5. Laboratory examination and ECG examination have obvious clinical significance abnormalities, which can affect the drug evaluation or the safety of the subjects;
7. AST and ALT were 2.0 times higher than the upper limit of normal value;
8. Those who have severe allergic constitution or are known to be allergic to traditional Chinese medicine ingredients used in this study;
9. Those who have severe allergic constitution or known to be allergic to traditional Chinese medicine ingredients used in this study have received sex hormone drug treatment or participated in other clinical trials in the past one month.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PSQI, KI, HAMA, HAMD;

Secondary Outcome Measures

Name	Time	Method
TCM symptom scale;