A Prospective Multi-Center Real-World Study of Ciwujia Capsules in the Treatment of Cancer-Related Insomnia

Launched by SHANGHAI MUNICIPAL HOSPITAL OF TRADITIONAL CHINESE MEDICINE · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether Ciwujia capsules, a type of herbal medicine made from Eleutherococcus senticosus extract, can help improve sleep problems in people with cancer-related insomnia. Many cancer patients have trouble sleeping due to the cancer itself, treatments like chemotherapy or surgery, pain, stress, or other symptoms. This study will look at how well Ciwujia capsules work to help these patients fall asleep, stay asleep, and wake up less early, with the goal of improving their overall quality of life.

Adults between 18 and 75 years old who have been diagnosed with cancer and are experiencing insomnia related to their cancer or its treatment may be eligible to join. Participants will be asked to take Ciwujia capsules and the study will track changes in their sleep quality over time. People with certain health issues, such as serious liver problems, severe mental health conditions, or uncontrolled severe pain, will not be able to join. The trial will take place at many centers over about three years and aims to include around 3,000 participants. This study is not yet recruiting but hopes to provide important information about the safety and effectiveness of this herbal treatment for helping cancer patients sleep better.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 and ≤75 years.
• • 2. Histologically and/or cytologically confirmed diagnosis of malignancy. 3.Meet the diagnostic criteria for insomnia disorder per the Chinese Guidelines for Diagnosis and Treatment of Insomnia in Adults (2023) with one of the following conditions: 1）Directly cancer-related insomnia: Insomnia symptoms (e.g. difficulty falling asleep sleep maintenance difficulties early awakening) directly attributable to cancer-associated factors: ① Tumor-related factors: Pain cachexia dyspnea cough pruritus tumor compression symptoms etc. ② Cancer treatment-related factors: Chemotherapy-induced nausea/vomiting post-radiation mucositis surgical trauma etc. ③ Cancer-associated complications: Anemia infections metabolic disturbances etc. 2）Indirectly cancer-related insomnia: Insomnia directly caused by psychological stress reactions to cancer diagnosis or disease progression such as fear/anxiety about disease progression concerns about treatment side effects financial burden or psychosocial factors (e.g. insufficient family support).
• • 4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. 5.Voluntarily participate and provide written informed consent.
• Exclusion Criteria:
• • 1. History of allergy to any component of the investigational product.
• • 2. Liver dysfunction with ALT/AST levels exceeding 1.5 times the upper limit of normal (ULN).
• • 3. Severe psychiatric disorders or emotional disturbances within the past year (e.g. anxiety depression suicidal tendencies or suicide attempts) requiring long-term use of CNS depressants or stimulants.
• • 4. Women who are pregnant breastfeeding or of childbearing potential unwilling to use effective contraception during the study.
• • 5. Insomnia secondary to uncontrolled severe cancer-related pain. 6.Participation in another clinical drug trial within the past month.