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

NCT07050121 | Not Yet Recruiting DMC

• 1 other identifier: 2025SHSZYYYRWS
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI)

  Assessments at baseline，day28±5，day56±5

Secondary Outcomes (3)

• Individual Components of the Pittsburgh Sleep Quality Index (PSQI)

  Assessments at baseline，day28±5，day56±5

• Insomnia Severity Index (ISI)

  Assessments at baseline，day14±3，day28±5，day56±5

• EORTC QLQ-C30

  Assessments at baseline，day14±3，day28±5，day56±5

Other Outcomes (10)

• Pharmacoeconomic Evaluation

  Assessments were performed after day 56 post-enrollment.

• Alanine Aminotransferase(ALT)

  Assessments at baseline, day56±5

• Urine Protein

  Assessments at baseline, day56±5

Study Arms (1)

Naturally Exposed Group

Patients voluntarily taking 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.

Drug: Ciwujia capsules

Interventions

Ciwujia capsules DRUG

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.

Naturally Exposed Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The purpose of this study is to evaluate the efficacy and safety of Ciwuja capsules in treating cancer-related insomnia in a real-world clinical setting. Cancer patients eligible for participation are not restricted by cancer type, disease stage, or treatment regimen, and may be enrolled after meeting the study's inclusion and exclusion criteria screening.

You may qualify if:

• Age ≥18 and ≤75 years.
• 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).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. 5.Voluntarily participate and provide written informed consent.

You may not qualify if:

• History of allergy to any component of the investigational product.
• Liver dysfunction with ALT/AST levels exceeding 1.5 times the upper limit of normal (ULN).
• 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.
• Women who are pregnant breastfeeding or of childbearing potential unwilling to use effective contraception during the study.
• Insomnia secondary to uncontrolled severe cancer-related pain. 6.Participation in another clinical drug trial within the past month.

Sponsors & Collaborators

• Shanghai Municipal Hospital of Traditional Chinese Medicine: lead
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• Henan Provincial Hospital of Integrated Traditional Chinese and Western Medicine: collaborator
• Shanghai East Hospital: collaborator
• Bao'an Authentic TCM therapy Hospital: collaborator
• Chengdu Fifth People's Hospital: collaborator
• Chengdu Shuangliu Traditional Chinese Medicine Hospital: collaborator
• Ezhou Traditional Chinese Medicine Hospital: collaborator
• Shanghai 7th People's Hospital: collaborator
• The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine: collaborator
• Putuo District Central Hospital of Shanghai: collaborator
• Fudan University: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

This study collects blood and urine samples from participants for safety assessments; however, sample collection is not mandatory and will be conducted solely based on participants' voluntary consent.

MeSH Terms

Conditions

Neoplasms; Sleep Initiation and Maintenance Disorders

Interventions

Siberian ginseng root

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jianhui Tian, Doctor

  Shanghai Municipal Hospital of Traditional Chinese Medicine - Oncology Research Center

  STUDY DIRECTOR

Central Study Contacts

Ze Liu, Master

CONTACT

86-13069967983; lzlz1136491317@163.com

Jialiang Yao, Doctor

CONTACT

jialiangyao@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 56 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 3, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 8, 2025

Record last verified: 2025-06