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

Summary

Cancer poses a severe threat to human physical and mental health as well as survival. High diagnostic rates of cancer and various treatments can significantly impact patients' sleep quality, leading to diverse sleep disorders. Cancer-related insomnia (CRI) is a prevalent sleep disturbance among cancer patients, potentially associated with the tumor itself, treatment modalities (such as surgery, chemotherapy, radiotherapy), psychological status, pain, fatigue, and other symptoms. Although reported incidence rates vary across studies, CRI is consistently high and severely compromises patients' quality of life. Core symptoms include difficulty falling asleep, sleep maintenance difficulties, and early morning awakening, which contribute to daytime fatigue, impaired concentration and memory, ultimately detrimentally affecting patients' health and quality of life. The pathogenesis of CRI is complex, potentially involving multiple factors including the tumor's direct effects, treatment side effects, psychological distress, pain, and fatigue.

The primary component of Ciwujia capsules (containing Eleutherococcus senticosus extract) is Ciwujia extract. To clarify the clinical efficacy of Ciwujia capsules for cancer-related insomnia in real-world clinical settings, this study will employ a multicenter, prospective, open-label, real-world research design. It is projected to involve 30-50 centers over an approximate 3-year trial period, with a planned enrollment of 3,000 subjects. Changes in sleep-related indicators before and after treatment will serve as the primary endpoint observation metrics. The study aims to investigate the clinical efficacy and safety profile of Ciwujia capsules in treating insomnia disorders in cancer patients, thereby providing robust evidence for identifying effective Chinese herbal medicine therapies for sedation and sleep promotion.

Conditions

• Cancer
• Insomnia
• Cancer Related Insomnia

Interventions

DRUG

Ciwujia capsules

Ciwujia capsules for oral use，2-3 capsules per dose, three times daily. 28 days constitute one treatment course; efficacy and safety will be assessed over two courses. Dosage adjustments should follow the physician's instructions.

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Henan Provincial Hospital of Integrated Traditional Chinese and Western Medicine

  collaborator UNKNOWN

• Shanghai East Hospital

  collaborator OTHER

• Bao'an Authentic TCM therapy Hospital

  collaborator UNKNOWN

• Chengdu Fifth People's Hospital

  collaborator OTHER

• Chengdu Shuangliu Traditional Chinese Medicine Hospital

  collaborator UNKNOWN

• Ezhou Traditional Chinese Medicine Hospital

  collaborator UNKNOWN

• Shanghai 7th People's Hospital

  collaborator OTHER

• The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

  collaborator UNKNOWN

• Putuo District Central Hospital of Shanghai

  collaborator UNKNOWN

• Fudan University

  collaborator OTHER

• Shanghai Municipal Hospital of Traditional Chinese Medicine

  lead OTHER

Principal Investigators

• Jianhui Tian, Doctor · Shanghai Municipal Hospital of Traditional Chinese Medicine - Oncology Research Center

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-25

Primary Completion

2028-10-31

Completion

2028-12-31