Chronic InsomniaShiwei-AnshenNCT07895329
Shiwei Anshen Granules for Chronic Insomnia
A study testing Shiwei Anshen granules in people with Chronic Insomnia, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial summary
This is a multi-center, randomized, controlled clinical study inlcuding 240 subjects with chronic insomnia. The purpose of this study is to evaluate the efficacy and safety of Shiwei Anshen Granules (an Chinese herbal preparation) in patients with chronic insomnia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Shiwei Anshen granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 31 Oct 2028
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting the clinical diagnostic criteria for chronic insomnia disorder.
- Subjects meeting the TCM differentiation criteria for syndrome of yin deficiency with effulgent fire and disharmony between heart and kidney.
- Aged from 18 to 65 years old (both endpoints included).
- Disease duration ≥ 3 months, with insomnia occurring ≥3 days per week. The habitual time in bed (time spent sleeping or attempting to fall asleep) ranges from 7 to 9 hours, accompanied by subjectively perceived sleep distress (complaints of dissatisfaction with nighttime sleep, manifested as difficulty falling asleep, difficulty maintaining sleep, and/or waking up earlier than expected in the morning).
- At least one daytime symptom associated with nighttime sleep disturbance (fatigue, depressed mood or irritability, physical discomfort, cognitive impairment, anxiety, etc.).
- Insomnia Severity Index (ISI) score ≥ 8 at the end of the placebo run-in period.
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- During the consecutive 7-day sleep diary recording at the end of placebo run-in period, there are at least 3 days meeting: subjective sleep onset latency (sSOL) ≥30 minutes, subjective wake after sleep onset (sWASO) ≥30 minutes, and subjective total sleep time (sTST) <6.5 hours.
- Able to cooperate and independently complete scale assessments and recordings.
- Able to understand and voluntarily sign the informed consent form.
Who cannot join
- History of sleep-related breathing disorders including chronic obstructive pulmonary disease, obstructive sleep apnea (with or without continuous positive airway pressure [CPAP] treatment), periodic limb movement disorder, myasthenia gravis, restless legs syndrome, circadian rhythm sleep-wake disorders, narcolepsy or other sleep disorders. Subjects with cured diseases mentioned above can be enrolled.
- Insomnia caused by other conditions such as chronic pain, headache, psychiatric disorders, malignant tumors, eczema, neurodermatitis, allergic rhinitis, severe dermatitis (sleep difficulty due to physical conditions or medical causes).
- Nocturia induced or aggravated by urinary tract infection, trauma, prostate diseases and other conditions.
- Previous complex sleep behaviors, such as sleep driving, sleep-related eating disorder, sleep calling and other behaviors.
- Daily excessive intake of tea or caffeinated beverages (defined as more than 4 cups of caffeinated drinks per day or caffeine intake>400 mg per day), or habitual consumption of caffeinated food or beverages after 18:00. If assessed as the main contributing factor for insomnia and expected to maintain such intake after enrollment.
- More than 10 cigarettes per day within 6 months before screening, or uncontrollable smoking before bedtime, and expected to smoke more than 10 cigarettes daily after enrollment.
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- Any lifestyle that interferes with trial progress or sleep assessment: cross-timezone travel across ≥3 time zones (Chinese mainland counts as one time zone) or shift work (alternating day and night shifts) within the recent two weeks or during the trial period.
- Depression: Hamilton Depression Scale (HAMD) score ≥18; Anxiety: Hamilton Anxiety Scale (HAMA) score ≥14; or subjects with suicidal ideation or behaviors.
- Subjects with severe endocrine diseases, hematological diseases, cardiovascular and cerebrovascular diseases, gastrointestinal diseases, liver and kidney diseases, autoimmune diseases, neuropsychiatric diseases, impaired respiratory function, or other medical histories considered by researchers that may affect subject safety or interfere with study evaluation.
- Plan to receive surgical operations during the study period.
- History of drug abuse, or positive result in any item of urine drug screening; history of drug addiction, drug use, alcohol dependence or abuse.
- Allergy to the investigational product or its ingredients.
- Participation in other drug clinical trials and receiving investigational products within 1 month or 5 half-lives (whichever is longer) before screening, or concurrent participation in other research trials during this trial.
- Pregnant or lactating women.
- Other conditions judged by researchers making the subject inappropriate to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Dongzhimen Hospital,Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100700
Jing Shi, MD, 86 10 84011920, shijing87@hotmail.com
About this study
Official title: Randomized, Double-blind, Multicenter, Placebo-controlled Clinical Trial of Shiwei Anshen Granules for Chronic Insomnia With Yin-Deficiency Fire-Hyperactivity and Heart-Kidney Disharmony Syndrome.
This is a multi-center, randomized, controlled clinical study inlcuding 240 subjects with chronic insomnia. The purpose of this study is to evaluate the efficacy and safety of Shiwei Anshen Granules (an Chinese herbal preparation) in patients with chronic insomnia. Eligible participants will be randomly assigned to receiving Shiwei Anshen Granules or the control group receiving placebo. All subjects will receive 2 weeks run-in period, followed 8 weeks of intervention and 2 weeks follow-up without treatment. The main outcome is the change in PSQI score before and after treatment. Safety indicators including routine blood, liver and kidney function and adverse events will be monitored throughout the study.
Read the detailed description
This is a multi-center, randomized, parallel-group, placebo-controlled clinical trial conducted at Dongzhimen Hospital, Beijing University of Chinese Medicine. Patients diagnosed with insomnia who meet all inclusion criteria and have no exclusion criteria will be recruited. After screening and signing informed consent forms, participants will be randomly divided into the treatment group and control group at a 1:1 ratio.
Participants in the treatment group will receive Shiwei Anshen Granules, an in-hospital Chinese herbal preparation of Dongzhimen Hospital. The control group will receive matched placebo granules with identical appearance, taste and packaging. The intervention period lasts for 8 weeks. During treatment, researchers will record sleep status, concomitant medications and adverse reactions at regular follow-up visits.
The primary objective is to assess the efficacy of Shiwei Anshen Granules on insomnia by comparing the change of Pittsburgh Sleep Quality Index (PSQI) from baseline to week 8 between two groups. Secondary outcomes include sleep latency, total sleep time, sleep efficiency and Traditional Chinese Medicine syndrome score. Safety assessments contain blood routine test, liver function, kidney function and the incidence of adverse events. All adverse events will be recorded and followed up until resolution or stabilization.
All participants will voluntarily join this study and sign written informed consent. The trial has been approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine.
- Conditions
- Chronic Insomnia
- Being tested
- Shiwei Anshen granules, Placebo granules
- Keywords
- Insomnia, Chinese herbal medicine, Randomized controlled trial, Shiwei Anshen Granules, Pittsburgh Sleep Quality Index
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shiwei Anshen granulesDrug
Shiwei Anshen granules, taken 1 times daily (10g)for 8 consecutive weeks to treat insomnia.
Placebo granulesDrug
Placebo granules with identical appearance, color, smell and taste to Shiwei Anshen Granules. Oral administration, taken 1 times daily for 8 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Participants take Shiwei Anshen Granules orally, twice daily for 8 weeks, combined with 2-week placebo run-in period. Receives: Drug: Shiwei Anshen granules |
| Control Arm | Placebo comparator | Participants take matched placebo granules orally, twice daily for 8 weeks, combined with 2-week placebo run-in period. Receives: Drug: Placebo granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pittsburgh Sleep Quality Index (PSQI) total score
The change of PSQI total score from baseline to week 8. Lower score indicates better sleep quality.
Measured: Baseline, 4 weeks, 8 weeks after treatment
Secondary outcomes (3)
Insomnia Severity Index (ISI) score change
Change of ISI score from baseline to week 8 to assess insomnia severity
Measured: Baseline, 4 weeks, 8 weeks
Traditional Chinese Medicine Syndrome Score change
Variation of TCM syndrome score before and after intervention
Measured: Baseline, 4 weeks, 8 weeks
Adverse events
Incidence of adverse events during the 8-week treatment period to evaluate safety.
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 1:1 parallel-group randomized controlled trial. Eligible participants will enter a 2-week placebo run-in period, then be randomly assigned to receive either Shiwei Anshen Granule or matched placebo granule for 8 weeks of double-blind treatment. After treatment, there is a 2-week follow-up period. Randomization is stratified by study center.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Shijiazhuang Pingan Hospital, Beijing Hospital of Traditional Chinese Medicine, Beijing Friendship Hospital, Beijing Fangshan District Hospital of Traditional Chinese Medicine, The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing Changping District Hospital, Xiamen Hospital of Traditional Chinese Medicine, Capital Medical University, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Beijing Xuanwu Traditional Chinese Medicine Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Beijing Longfu Hospital, Shunyi Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Jinzhou Tian, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895329
- Sponsor's protocol ID
- 2026DZMEC-213-02
- Other IDs
- 2025ZD1801800
- Acronym
- Shiwei-Anshen
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly. The raw data contains sensitive personal health information of participants, and data sharing is restricted by local privacy regulations.
Publications
China Food and Drug Administration. Guidelines for Planning and Reporting on Drug Clinical Trial Data Management and Statistical Analysis. 2016.
China Food and Drug Administration. Technical Guidance for Clinical Trial Data Management. 2016.
Chinese Sleep Research Society. [Guidelines for the diagnosis and treatment of insomnia disorder (2025 edition)]. Zhonghua Yi Xue Za Zhi. 2025 Sep 9;105(34):2960-2981. doi: 10.3760/cma.j.cn112137-20250421-00981. Chinese.
PubMed 40904305Sleep Disorders Group, Chinese Society of Neurology. Chinese guideline for diagnosis and treatment of adult insomnia (2023 edition). Chinese Journal of Neurology, 2024, 57(6): 560-584.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Multicenter, Placebo-controlled Clinical Trial of Shiwei Anshen Granules for Chronic Insomnia With Yin-Deficiency Fire-Hyperactivity and Heart-Kidney Disharmony Syndrome.
- ClinicalTrials.gov ID
- NCT07895329
- Acronym / sponsor ID
- Shiwei-Anshen / 2026DZMEC-213-02
- Conditions
- Chronic Insomnia
- Keywords
- Insomnia, Chinese herbal medicine, Randomized controlled trial, Shiwei Anshen Granules, Pittsburgh Sleep Quality Index
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Collaborators
- Shijiazhuang Pingan Hospital, Beijing Hospital of Traditional Chinese Medicine, Beijing Friendship Hospital, Beijing Fangshan District Hospital of Traditional Chinese Medicine, The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing Changping District Hospital, Xiamen Hospital of Traditional Chinese Medicine, Capital Medical University, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Beijing Xuanwu Traditional Chinese Medicine Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Beijing Longfu Hospital, Shunyi Hospital of Traditional Chinese Medicine
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 26 Oct 2026 (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.
This is a multi-center, randomized, controlled clinical study inlcuding 240 subjects with chronic insomnia. The purpose of this study is to evaluate the efficacy and safety of Shiwei Anshen Granules (an Chinese herbal preparation) in patients with chronic insomnia. Eligible participants will be randomly assigned to receiving Shiwei Anshen Granules or the control group receiving placebo. All subjects will receive 2 weeks run-in period, followed 8 weeks of intervention and 2 weeks follow-up without treatment. The main outcome is the change in PSQI score before and after treatment. Safety indicators including routine blood, liver and kidney function and adverse events will be monitored throughout the study.
Detailed description
This is a multi-center, randomized, parallel-group, placebo-controlled clinical trial conducted at Dongzhimen Hospital, Beijing University of Chinese Medicine. Patients diagnosed with insomnia who meet all inclusion criteria and have no exclusion criteria will be recruited. After screening and signing informed consent forms, participants will be randomly divided into the treatment group and control group at a 1:1 ratio.
Participants in the treatment group will receive Shiwei Anshen Granules, an in-hospital Chinese herbal preparation of Dongzhimen Hospital. The control group will receive matched placebo granules with identical appearance, taste and packaging. The intervention period lasts for 8 weeks. During treatment, researchers will record sleep status, concomitant medications and adverse reactions at regular follow-up visits.
The primary objective is to assess the efficacy of Shiwei Anshen Granules on insomnia by comparing the change of Pittsburgh Sleep Quality Index (PSQI) from baseline to week 8 between two groups. Secondary outcomes include sleep latency, total sleep time, sleep efficiency and Traditional Chinese Medicine syndrome score. Safety assessments contain blood routine test, liver function, kidney function and the incidence of adverse events. All adverse events will be recorded and followed up until resolution or stabilization.
All participants will voluntarily join this study and sign written informed consent. The trial has been approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a 1:1 parallel-group randomized controlled trial. Eligible participants will enter a 2-week placebo run-in period, then be randomly assigned to receive either Shiwei Anshen Granule or matched placebo granule for 8 weeks of double-blind treatment. After treatment, there is a 2-week follow-up period. Randomization is stratified by study center.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Shiwei Anshen granulesParticipants take Shiwei Anshen Granules orally, twice daily for 8 weeks, combined with 2-week placebo run-in period. |
| Control Arm | Placebo comparator | Drug: Placebo granulesParticipants take matched placebo granules orally, twice daily for 8 weeks, combined with 2-week placebo run-in period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects meeting the clinical diagnostic criteria for chronic insomnia disorder.
- Subjects meeting the TCM differentiation criteria for syndrome of yin deficiency with effulgent fire and disharmony between heart and kidney.
- Aged from 18 to 65 years old (both endpoints included).
- Disease duration ≥ 3 months, with insomnia occurring ≥3 days per week. The habitual time in bed (time spent sleeping or attempting to fall asleep) ranges from 7 to 9 hours, accompanied by subjectively perceived sleep distress (complaints of dissatisfaction with nighttime sleep, manifested as difficulty falling asleep, difficulty maintaining sleep, and/or waking up earlier than expected in the morning).
- At least one daytime symptom associated with nighttime sleep disturbance (fatigue, depressed mood or irritability, physical discomfort, cognitive impairment, anxiety, etc.).
Key exclusion criteria (15 listed)
- History of sleep-related breathing disorders including chronic obstructive pulmonary disease, obstructive sleep apnea (with or without continuous positive airway pressure [CPAP] treatment), periodic limb movement disorder, myasthenia gravis, restless legs syndrome, circadian rhythm sleep-wake disorders, narcolepsy or other sleep disorders. Subjects with cured diseases mentioned above can be enrolled.
- Insomnia caused by other conditions such as chronic pain, headache, psychiatric disorders, malignant tumors, eczema, neurodermatitis, allergic rhinitis, severe dermatitis (sleep difficulty due to physical conditions or medical causes).
- Nocturia induced or aggravated by urinary tract infection, trauma, prostate diseases and other conditions.
- Previous complex sleep behaviors, such as sleep driving, sleep-related eating disorder, sleep calling and other behaviors.
- Daily excessive intake of tea or caffeinated beverages (defined as more than 4 cups of caffeinated drinks per day or caffeine intake>400 mg per day), or habitual consumption of caffeinated food or beverages after 18:00. If assessed as the main contributing factor for insomnia and expected to maintain such intake after enrollment.
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 |
|---|---|---|
| Shiwei Anshen granulesShiwei Anshen granules, taken 1 times daily (10g)for 8 consecutive weeks to treat insomnia. | Drug | Treatment Arm |
| Placebo granulesPlacebo granules with identical appearance, color, smell and taste to Shiwei Anshen Granules. Oral administration, taken 1 times daily for 8 consecutive weeks. | Drug | Control Arm |
Primary outcome
Change in Pittsburgh Sleep Quality Index (PSQI) total score
Time frame: Baseline, 4 weeks, 8 weeks after treatment
The change of PSQI total score from baseline to week 8. Lower score indicates better sleep quality.
3 secondary outcomes
Insomnia Severity Index (ISI) score change
Time frame: Baseline, 4 weeks, 8 weeks
Traditional Chinese Medicine Syndrome Score change
Time frame: Baseline, 4 weeks, 8 weeks
Adverse events
Time frame: Baseline, 4 weeks, 8 weeks
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 26 Oct 2026.
- Results publicationChina Food and Drug Administration. Guidelines for Planning and Reporting on Drug Clinical Trial Data Management and Statistical Analysis. 2016.
- Results publicationChina Food and Drug Administration. Technical Guidance for Clinical Trial Data Management. 2016.
- Results publication: PubMed 40904305Chinese Sleep Research Society. [Guidelines for the diagnosis and treatment of insomnia disorder (2025 edition)]. Zhonghua Yi Xue Za Zhi. 2025 Sep 9;105(34):2960-2981. doi: 10.3760/cma.j.cn112137-20250421-00981. Chinese.
- Results publicationSleep Disorders Group, Chinese Society of Neurology. Chinese guideline for diagnosis and treatment of adult insomnia (2023 edition). Chinese Journal of Neurology, 2024, 57(6): 560-584.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly. The raw data contains sensitive personal health information of participants, and data sharing is restricted by local privacy regulations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shiwei Anshen granules in people with Chronic Insomnia, run by Dongzhimen Hospital, Beijing at 1 site in China.
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 9 inclusion and 15 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Jing Shi, MD (86 10 84011920, shijing87@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pittsburgh Sleep Quality Index (PSQI) total score (time frame: Baseline, 4 weeks, 8 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07895329, which also lists 4 linked publications.
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 26 Oct 2026.