Primary InsomniaNCT01613183
Exploratory Study of Effective Core Formula of Chinese Medicine to Treat Primary Insomnia
A study testing Chinese herbal Medicine and the dummy of a Chinese Medicine prescription in people with Primary Insomnia, run by China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The objective of this study is to screen the effective core formulation in insomnia treatment with Chinese medicine with a double-blind, randomized, placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- Chinese herbal Medicine and the dummy of a Chinese Medicine prescription
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- May 2012to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- aged between 18 and 65 years,
- meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) of insomnia,
- Spiegel scale score is ≥ 18,
- The informed consent must be obtained from patient
Who cannot join
- total sleep time ≤ 2 hours,
- secondary insomnia,
- Self-rating Anxiety Scale (SAS) score ≥ 18,
- Beck Depression Inventory (BDI) score ≥ 6,
- having hypertension, diabetes, stroke, and coronary heart disease,
- have drug abuse history,
Show all 9Show fewer
- pregnancy or preparing to pregnancy,
- used immunotherapy or hormone therapy in past 1 years,
- participating in another clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen hospital, China Academy of Chinese Medical Sciences
Beijing, 100700
Runshun Zhang, Doctor, +86-010-84001440
About this study
The objective of this study is to screen the effective core formulation in insomnia treatment with Chinese medicine with a double-blind, randomized, placebo-controlled trial.
- Conditions
- Primary Insomnia
- Being tested
- Chinese herbal Medicine, the dummy of a Chinese Medicine prescription
- 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.
Chinese herbal MedicineDrug
The intervention of Chinese Medicine group is not fixed. The clinicians provide the prescription to patient base their own Chinese Medicine theory. Chinese clinicians can adjust the medicinal in prescription based on the condition of patient during the treatment procedure. The prescription of Chinese clinicians' are pure Chinese herb.
the dummy of a Chinese Medicine prescriptionOther
Patients in placebo group will receive the dummy of the core drug patterns screened in previous retrospective study. The previous core drug patterns include Fried semen Ziziphi Spinosae, Tuckahoe, Preparation of Polygala, Chinese Angelica root, Lotus heart, White peony root, dried tangerine peel, acorus calamus, Coptis chinensis, and Licorice health.
| Study group | Role | What they receive |
|---|---|---|
| Chinese Medicine group | Experimental | Chinese Medicine prescription of one of three prestigious Chinese medicine clinicians Receives: Drug: Chinese herbal Medicine |
| placebo group | Placebo comparator | Not described Receives: Other: the dummy of a Chinese Medicine prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in Total Sleep Time (TST) at 4 weeks
Measured: baseline and 4 weeks
Secondary outcomes (5)
change from baseline in sleep onset latency at 4 weeks
Measured: baseline and 4 weeks
change from baseline in wake time after sleep onset at 4 weeks
Measured: baseline and 4 weeks
change from baseline in sleep efficiency at 4 weeks
Measured: baseline and 4 weeks
change from baseline in Pittsburgh sleep quality index (PSQI) at 4 weeks
Measured: baseline and 4 weeks
change from baseline in Chinese Medicine symptoms and signs at 4 weeks
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liyun He, China Academy of Chinese Medical Sciences
- Investigators
- Liyun He, Doctor, Study chair, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613183
- Sponsor's protocol ID
- PJZX-001
- Other IDs
- 81072920
- Status last verified
- Jun 2012
- First submitted
- 16 May 2012
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Xiong ZY, Lu Y, He LY, Zhang RS, Zhou XZ, Li P, Liu YJ, Zhu JG, Yan SY, Liu BY. Efficacy of Chinese Medicine Treatment Based on Syndrome Differentiation for Primary Insomnia: A Randomized Placebo Controlled Triple-Blinded Trial. Chin J Integr Med. 2024 Oct;30(10):867-876. doi: 10.1007/s11655-024-3661-4. Epub 2024 May 16.
PubMed 38753273Yan S, Zhang R, Zhou X, Li P, He L, Liu B. Exploring effective core drug patterns in primary insomnia treatment with Chinese herbal medicine: study protocol for a randomized controlled trial. Trials. 2013 Feb 28;14:61. doi: 10.1186/1745-6215-14-61.
PubMed 23448313
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Effective Core Formula of Chinese Medicine to Treat Primary Insomnia
- ClinicalTrials.gov ID
- NCT01613183
- Acronym / sponsor ID
- PJZX-001
- Conditions
- Primary Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- May 2012
- First posted
- 7 Jun 2012 (estimated)
- 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.
The objective of this study is to screen the effective core formulation in insomnia treatment with Chinese medicine with a double-blind, randomized, placebo-controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese Medicine group | Experimental | Drug: Chinese herbal MedicineChinese Medicine prescription of one of three prestigious Chinese medicine clinicians |
| placebo group | Placebo comparator | Other: the dummy of a Chinese Medicine prescription |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged between 18 and 65 years,
- meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) of insomnia,
- Spiegel scale score is ≥ 18,
- The informed consent must be obtained from patient
Key exclusion criteria (9 listed)
- total sleep time ≤ 2 hours,
- secondary insomnia,
- Self-rating Anxiety Scale (SAS) score ≥ 18,
- Beck Depression Inventory (BDI) score ≥ 6,
- having hypertension, diabetes, stroke, and coronary heart disease,
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 |
|---|---|---|
| Chinese herbal MedicineThe intervention of Chinese Medicine group is not fixed. The clinicians provide the prescription to patient base their own Chinese Medicine theory. Chinese clinicians can adjust the medicinal in prescription based on the condition of patient during the treatment procedure. The prescription of Chinese clinicians' are pure Chinese herb. | Drug | Chinese Medicine group |
| the dummy of a Chinese Medicine prescriptionPatients in placebo group will receive the dummy of the core drug patterns screened in previous retrospective study. The previous core drug patterns include Fried semen Ziziphi Spinosae, Tuckahoe, Preparation of Polygala, Chinese Angelica root, Lotus heart, White peony root, dried tangerine peel, acorus calamus, Coptis chinensis, and Licorice health. | Other | placebo group |
Primary outcome
change from baseline in Total Sleep Time (TST) at 4 weeks
Time frame: baseline and 4 weeks
5 secondary outcomes
change from baseline in sleep onset latency at 4 weeks
Time frame: baseline and 4 weeks
change from baseline in wake time after sleep onset at 4 weeks
Time frame: baseline and 4 weeks
change from baseline in sleep efficiency at 4 weeks
Time frame: baseline and 4 weeks
change from baseline in Pittsburgh sleep quality index (PSQI) at 4 weeks
Time frame: baseline and 4 weeks
change from baseline in Chinese Medicine symptoms and signs at 4 weeks
Time frame: baseline and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
- Derived from this study: PubMed 38753273Xiong ZY, Lu Y, He LY, Zhang RS, Zhou XZ, Li P, Liu YJ, Zhu JG, Yan SY, Liu BY. Efficacy of Chinese Medicine Treatment Based on Syndrome Differentiation for Primary Insomnia: A Randomized Placebo Controlled Triple-Blinded Trial. Chin J Integr Med. 2024 Oct;30(10):867-876. doi: 10.1007/s11655-024-3661-4. Epub 2024 May 16.
- Derived from this study: PubMed 23448313Yan S, Zhang R, Zhou X, Li P, He L, Liu B. Exploring effective core drug patterns in primary insomnia treatment with Chinese herbal medicine: study protocol for a randomized controlled trial. Trials. 2013 Feb 28;14:61. doi: 10.1186/1745-6215-14-61.
Related trials for Primary Insomnia
Recruiting
Effect of Lifestyle Intervention on Menopausal Symptoms, Sleep Quality, and Anxiety in Peri- and Postmenopausal Women
Perimenopause, Postmenopause
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
Active Coping: Interdisciplinary Program for Chronic Pain, Physiotherapy Unit (Spain)
Chronic Back Pain, Chronic Pain
Not yet recruitingObservational study
Tension-type Headache and Its Association
Tension-Type Headache, Sleep Disturbance
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
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. This study is not recruiting at the moment.
Liyun He, Doctor study chair
China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese herbal Medicine and the dummy of a Chinese Medicine prescription in people with Primary Insomnia, run by China Academy of Chinese Medical Sciences 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Jun 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng Li, Bachelor (+8613810991638, leepanns@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in Total Sleep Time (TST) at 4 weeks (time frame: baseline and 4 weeks). 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 NCT01613183, which also lists 2 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 7 Jun 2012.