CancerNCT07050121
A Prospective Multi-Center Real-World Study of Ciwujia Capsules in the Treatment of Cancer-Related Insomnia
An observational study of Cancer and Insomnia, run by Shanghai Municipal Hospital of Traditional Chinese Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer, Insomnia, Cancer Related Insomnia
- What is being tested?
- Ciwujia capsules
- Type of treatment
- Pill or oral medicine
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2025to 31 Dec 2028
- How long will I take part?
- 56 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
- 4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. 5.Voluntarily participate and provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jialiang Yao, Doctor contact
About this study
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
- Being tested
- Ciwujia capsules
- Medical subject headings
- Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciwujia capsulesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ciwujia capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
Measured: Assessments at baseline，day28±5，day56±5
Secondary outcomes (3)
Individual Components of the Pittsburgh Sleep Quality Index (PSQI)
Including sleep latency, subjective sleep quality, sleep continuity, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. Each component will be assessed.
Measured: Assessments at baseline，day28±5，day56±5
Insomnia Severity Index (ISI)
Measured: Assessments at baseline，day14±3，day28±5，day56±5
EORTC QLQ-C30
Measured: Assessments at baseline，day14±3，day28±5，day56±5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start25 Jul 2025 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 56 Days
Sponsor and investigators
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine, Henan Provincial Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai East Hospital, Bao'an Authentic TCM therapy Hospital, Chengdu Fifth People's Hospital, Chengdu Shuangliu Traditional Chinese Medicine Hospital, Ezhou Traditional Chinese Medicine Hospital, Shanghai 7th People's Hospital, Shaanxi Hospital of Traditional Chinese Medicine, Putuo District Central Hospital of Shanghai, Fudan University
- Responsible party
- Sponsor
- Investigators
- Jianhui Tian, Doctor, Study director, Shanghai Municipal Hospital of Traditional Chinese Medicine - Oncology Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050121
- Sponsor's protocol ID
- 2025SHSZYYYRWS
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Center Real-World Study of Ciwujia Capsules in the Treatment of Cancer-Related Insomnia
- ClinicalTrials.gov ID
- NCT07050121
- Acronym / sponsor ID
- 2025SHSZYYYRWS
- Conditions
- Cancer, Insomnia, Cancer Related Insomnia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine, Henan Provincial Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai East Hospital, Bao'an Authentic TCM therapy Hospital, Chengdu Fifth People's Hospital, Chengdu Shuangliu Traditional Chinese Medicine Hospital, Ezhou Traditional Chinese Medicine Hospital, Shanghai 7th People's Hospital, Shaanxi Hospital of Traditional Chinese Medicine, Putuo District Central Hospital of Shanghai, Fudan University
- Study start
- 25 Jul 2025 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 56 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naturally Exposed Group | – | Drug: Ciwujia capsulesPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
- 4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. 5.Voluntarily participate and provide written informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciwujia capsulesCiwujia 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 | Naturally Exposed Group |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Assessments at baseline，day28±5，day56±5
3 secondary outcomes
Individual Components of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Assessments at baseline，day28±5，day56±5
Insomnia Severity Index (ISI)
Time frame: Assessments at baseline，day14±3，day28±5，day56±5
EORTC QLQ-C30
Time frame: Assessments at baseline，day14±3，day28±5，day56±5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jialiang Yao, Doctor contact
Jianhui Tian, Doctor study director
Shanghai Municipal Hospital of Traditional Chinese Medicine - Oncology Research Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Insomnia, run by Shanghai Municipal Hospital of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ze Liu, Master (86-13069967983, lzlz1136491317@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: Assessments at baseline，day28±5，day56±5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.