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A clinical study of Tiaoshen Zhicancer decoction in the treatment of insomnia associated with ovarian cancer

A clinical study of Tiaoshen Zhicancer decoction in the treatment of insomnia associated with ovarian cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084163
Enrollment
Unknown
Registered
2024-05-11
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Ovarian cancer

Interventions

Control group:Tiaoshen Zhicancer decoction granule mimics agent
Experimental group:Tiaoshen Zhicancer prescription

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) patients with postoperative pathological diagnosis of cancer (NCCN clinical practice Guidelines for Ovarian Cancer 2019); (2) age >18 years old, education level of primary school or above, and ability to independently complete the questionnaire; (3) patients with insomnia according to ICSD-3; Sleep disorder was almost the only symptom, and other symptoms were secondary to insomnia, including difficulty falling asleep, not sleeping deeply, dreaming more, waking up early, not easy to fall asleep again after waking up, discomfort after waking up, fatigue or daytime sleepiness. The above sleep disorders occurred at least 3 times per week and lasted for more than 1 month. (5) Quality of life scale score (functional domain 60 points); (6) Informed consent of the patients and their ability to cooperate with long-term follow-up.

Exclusion criteria

Exclusion criteria: (1) previous history of other mental disorders; (2) complicated with serious cardiovascular and cerebrovascular diseases, respiratory system diseases, or serious underlying diseases; (3) complicated with severe infectious diseases; (4) undergoing other clinical trials at the time of enrollment; (5) with suicidal behavior tendency.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index PSQI scale;Quality of life scale ;

Secondary

MeasureTime frame
Generalized Anxiety Disorder-7 (GAD-7);Patient Health Questionnaire-9,PHQ-9;immune indice;Neuroendocrine markers;

Countries

China

Contacts

Public ContactTian Jianhui

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine

jialiangyao@126.com+86 137 3319 4162

Outcome results

None listed

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