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A clinical randomized controlled trial to assess the effect and to explore the mechanism based on Traditional Chinese Medicine theory about 'liver Qi Yu zheng' on the treatment of severe premenstrual syndrome

A clinical randomized controlled trial to assess the effect and to explore the mechanism based on Traditional Chinese Medicine theory about 'liver Qi Yu zheng' on the treatment of severe premenstrual syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004172
Enrollment
Unknown
Registered
2014-01-20
Start date
2013-11-15
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

premenstrual syndrome

Interventions

Experimental :Shu-gan Mianjian granule + fluoxetine
Control :Oral Fluoxetine

Sponsors

Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. To be diagnosed according to the PMDD Diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV); 2. Aged 18-45 years women, no ethnic limitation; 3. The menstrual cycle of 21-35 days (fluctuation range = 3d); 4. The voluntarily volunteers with the clear consciousness, independent judgment and the ability to understand the purpose of the study; 5. The volunteers without other major mood disorders, brain tumors or other brain disease and history of taking psychotropic medications.

Exclusion criteria

Exclusion criteria: 1. Patients with severe suicidal thoughts or behavior; 2. Patients with loss or lack of ability of independent judgment; 3. Don't understand the purpose of this study or unwilling to cooperate; 4. The depression patients resulted in organic diseases or psychoactive drug substances or nonaddictive substances.

Design outcomes

Primary

MeasureTime frame
COR;ACTH;5-HT;NE;BDNF;GABA;Tryptophan;TPH;5-HTPDC;MAO;5-HIAA;

Countries

China

Contacts

Public ContactQiao Mingqi

Shandong University of Traditional Chinese Medicine

qmingqi@163.com+86 13553168096

Outcome results

None listed

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