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Clinical Trials/ITMCTR2000003635
ITMCTR2000003635
Not yet recruiting
Phase 1

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

Shanghai Municipal Hospital Traditional Chinese Medicine0 sitesTBD
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Shanghai Municipal Hospital Traditional Chinese Medicine
Status
Not yet recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional study
Sex
Female

Investigators

Sponsor
Shanghai Municipal Hospital Traditional Chinese Medicine

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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