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A clinical research of Chinese herbal formulae for menopausal insomnia

A randomized double blind comparison of Suan Tsao Jen Tang and Jia Wey Shiau Yau San in menopause women with primary insomnia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001399
Enrollment
Unknown
Registered
2011-07-01
Start date
2009-03-30
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

Menopausal insomnia

Interventions

A:SZRT 4 gm 3 times per day
B:JWSYS 4 gm 3 times per day

Sponsors

Taipei City Hospital, Yang-Ming branch
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: The subjects enrolled in the study were climacteric women, ranging in age from 40 to 60 years, with a Pittsburgh Sleep Quality Index (PSQI) of greater than six.All women spent 30 minutes or more falling asleep per night, slept less than six hours each night three times per week, and had this issue continuously for at least one month.

Exclusion criteria

Exclusion criteria: Women could not have participated in any other medical trial for at least three months prior to the enrollment and should have discontinued taking current medications prior to screening: 2 weeks for any herbal medications, melatonin, acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, and prostaglandins; 12 weeks for estrogens or progestational agents. Additionally, subjects who had shift work-induced insomnia, any sign of cancer or treatment with chemotherapy or radiation therapy, any disease that might cause sleep difficulty including psychosis, depression, thyroid dysfunction, obstructive sleep apnea syndrome, and cardiac disease, or showed evidence of renal or liver dysfunction were excluded from the study.

Design outcomes

Primary

MeasureTime frame
World Health Organization Quality of Life question;Pittsburgh Sleep Quality Index (PSQI);

Secondary

MeasureTime frame
Menopause Rating Scale (MRS);

Countries

China

Contacts

Public ContactJung-Nien Lai
kareny@ms10.hinet.net+886–2-28267396

Outcome results

None listed

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