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Clinical effect of traditional Chinese medicine on tumor related sleep disorders

Clinical study on modified Ganmai Dazhao Decoction in the treatment of female tumor related sleep disorder and regulation of neuroendocrine axis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062080
Enrollment
Unknown
Registered
2022-07-21
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Tumor associated sleep disorder

Interventions

control group :Sedative hypnotic drugs
Experimental group:Sedative hypnotic drugs +Chinese traditional medicine(TCM)

Sponsors

Yueyang integrated traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as malignant tumors by pathological diagnosis; 2. Have typical insomnia symptoms, meet the diagnostic criteria of Western medicine, and the PSQI score is greater than 7; 3. Female, aged from 18 to 75 years (including both sides), with stable vital signs, expected survival of more than 6 months, and clear consciousness; 4. The patients had no major organ dysfunction or pain, and the NRS score was 0-3; 5. Those who have taken sedative and hypnotic drugs (estazolam tablets or zolpidem tablets) for no more than 1 month before enrollment. 6. Understand and agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have serious diseases such as heart, liver, kidney and hematopoietic system, pregnant or lactating patients, and have a history of mental illness that is difficult to control; ? 2. Patients with intracranial tumors and cognitive impairment; 3. Known allergy to the ingredients of this traditional Chinese medicine; 4. Participating in clinical trials of other drugs or within 4 weeks; 5. Patients who received tumor related surgery, chemotherapy or radiotherapy in recent 1 month.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index, PSQI;

Countries

China

Contacts

Public ContactChai Ni
chaini7@126.com+86 18001868207

Outcome results

None listed

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