InsomniaNCT05666531
Research on Innovative Diagnosis and Treatment System of Syndrome Differentiation of Zang-fu Viscera and Effectiveness Evaluation Based on Inter-Arm Blood Pressure Measured Simultaneously
An observational study of Insomnia and Chronic Gastritis, run by Liyun He at 1 site in China.
Trial summary
By combining the measurement of blood pressure in both arms with the information of the four diagnoses of TCM, we try to form a diagnostic model of "five diagnoses combined with ginseng" based on TCM Zang-fu syndrome differentiation. It can further objectify and visualize the fuzzy four diagnostic indicators of TCM. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Chronic Gastritis
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Physical examination center and Hospital Outpatient Clinic
Who may be able to join
- Case inclusion Criteria:
- Patients were treated with epigastric pain and / or insomnia, which met the above diagnostic criteria for diseases, liver and spleen;
- diagnostic criteria for diseases, liver and spleen;
- Age 18-65 years old;
- It can combine mild and moderate depression, anxiety Sign the informed consent form.
- Healthy control inclusion criteria:
Show all 11Show fewer
- PSQI < 5 points;
- No hypertension, diabetes, hyperlipidemia, coronary heart disease and other underlying diseases;
- No depression, anxiety, malignant tumor, syphilis, HIV and other infectious diseases;
- Over 18 years of age;
- Volunteer to participate in this study, cooperate with the measurement of blood pressure in both arms, and sign the informed consent.
Who cannot join
- Case exclusion criteria:
- Patients with insomnia disorder caused by uneffectively controlled or serious diseases, such as malignant tumor, persistent pain, cardiovascular and cerebrovascular diseases, endocrine diseases, etc.;
- patients with severe depression and mental illness;
- Pregnant and lactation patients.
- Healthy controls exclusion criteria:
- sleep apnea syndrome or restless leg syndrome and other sleep disorders;
- Pregnant and lactation;
- Abnormal symptoms and abnormal tongue pulse occur in the body, such as facial acne, dysmenorrhea, thick and greasy tongue coating, loose stools, fat tongue, teeth marks and tongue.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Shijitan Hospital, Capital Medical University
Beijing
Liyun HE, 13581770875, hely3699@163.com
About this study
By combining the measurement of blood pressure in both arms with the information of the four diagnoses of TCM, we try to form a diagnostic model of "five diagnoses combined with ginseng" based on TCM Zang-fu syndrome differentiation. It can further objectify and visualize the fuzzy four diagnostic indicators of TCM. In order to solve the problem of data differentiation of TCM four diagnoses, and optimize the five diagnoses of TCM conjunctive index, explore the establishment of TCM intelligent diagnosis and treatment and contact evaluation computer system
- Conditions
- Insomnia, Chronic Gastritis
- Keywords
- Blood pressure in both arms, syndrome differentiation, liver-spleen disharmony, efficacy evaluation
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy people | The physical examination ruled out the disease | |
| Chronic gastritis | The endoscopic diagnosis is consistent with chronic gastritis or self-reported stomachache | |
| Insomnia | The Pittsburgh Sleep Quality Index Scale was measured and assessed as meeting a diagnosis of insomnia disorder or self-reported insomnia for more than three months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure measurement in both arms
The systolic blood pressure, diastolic blood pressure and pulse rate of the left and right upper arms were simultaneously measured by a standard dual-arm electronic sphygmomanometer. A total of 6 data were collected. A total of 30 data were collected and measured for 5 times without interruption, which was used to judge the functional balance state of "Zang-fu regional tissues" in human body.
Measured: 5minutes
Secondary outcomes (6)
Pulse diagnosis information
The data collected by tongue pulse analyzer were used as one of the diagnostic information of hepatic and splenic dysregulation
Measured: 10minutes
Pittsburgh Sleep Quality Index (PSQI）
Pittsburgh Sleep Quality Index (PSQI）,used to assess the actual sleep status in the last 1 month.The total score ranges from 0 to 2l, with higher scores indicating poorer sleep quality
Measured: 5minutes
Hamilton Anxiety Scale (HAMA)
Hamilton Anxiety Scale (HAMA),used to assess the severity of anxiety symptoms.The total score ranges from 0 to 56, with higher scores indicating more anxiety.
Measured: 5minutes
Hamilton Depression Scale (HAMD)
Hamilton Depression Scale (HAMD), used to assess the severity of depression.The total score ranges from 0 to 96, with higher scores indicating more severe depression.
Measured: 5minutes
Gastrointestinal Symptom Scale
Gastrointestinal Symptom Rating Scale (GSRS),used to assess gastrointestinal function for nearly one week.The total score ranges from 0 to 112, with higher scores indicating more severe gastrointestinal symptoms.
Measured: 5minutes
Grade table of main disorders of liver and spleen
Grade table of main disorders of liver and spleen, used to assess the severity of the disorder of liver and spleen. The total score ranges from 0 to 24, with higher scores indicating more severe disorder of liver and spleen.
Measured: 5minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liyun He
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, Beijing Shijitan Hospital, Capital Medical University, Affiliated Hospital of Inner Mongolia Minzu University, Hohhot Hospital of Mongolian Medicine and TCM
- Responsible party
- Sponsor-investigator, Liyun He, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666531
- Sponsor's protocol ID
- 2022-1-4301
- Status last verified
- Dec 2022
- First submitted
- 10 Dec 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Innovative Diagnosis and Treatment System of Syndrome Differentiation of Zang-fu Viscera and Effectiveness Evaluation Based on Inter-Arm Blood Pressure Measured Simultaneously
- ClinicalTrials.gov ID
- NCT05666531
- Acronym / sponsor ID
- 2022-1-4301
- Conditions
- Insomnia, Chronic Gastritis
- Keywords
- Blood pressure in both arms, syndrome differentiation, liver-spleen disharmony, efficacy evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Liyun HeUniversity, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, Beijing Shijitan Hospital, Capital Medical University, Affiliated Hospital of Inner Mongolia Minzu University, Hohhot Hospital of Mongolian Medicine and TCM
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Dec 2022 (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.
By combining the measurement of blood pressure in both arms with the information of the four diagnoses of TCM, we try to form a diagnostic model of "five diagnoses combined with ginseng" based on TCM Zang-fu syndrome differentiation. It can further objectify and visualize the fuzzy four diagnostic indicators of TCM. In order to solve the problem of data differentiation of TCM four diagnoses, and optimize the five diagnoses of TCM conjunctive index, explore the establishment of TCM intelligent diagnosis and treatment and contact evaluation computer system
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy people | – | –The physical examination ruled out the disease |
| Chronic gastritis | – | –The endoscopic diagnosis is consistent with chronic gastritis or self-reported stomachache |
| Insomnia | – | –The Pittsburgh Sleep Quality Index Scale was measured and assessed as meeting a diagnosis of insomnia disorder or self-reported insomnia for more than three months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physical examination center and Hospital Outpatient Clinic
Key inclusion criteria (11 listed)
- Patients were treated with epigastric pain and / or insomnia, which met the above diagnostic criteria for diseases, liver and spleen;
- diagnostic criteria for diseases, liver and spleen;
- Age 18-65 years old;
- It can combine mild and moderate depression, anxiety Sign the informed consent form.
- PSQI < 5 points;
Key exclusion criteria (8 listed)
- Patients with insomnia disorder caused by uneffectively controlled or serious diseases, such as malignant tumor, persistent pain, cardiovascular and cerebrovascular diseases, endocrine diseases, etc.;
- patients with severe depression and mental illness;
- Pregnant and lactation patients.
- sleep apnea syndrome or restless leg syndrome and other sleep disorders;
- Pregnant and lactation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood pressure measurement in both arms
Time frame: 5minutes
The systolic blood pressure, diastolic blood pressure and pulse rate of the left and right upper arms were simultaneously measured by a standard dual-arm electronic sphygmomanometer. A total of 6 data were collected. A total of 30 data were collected and measured for 5 times without interruption, which was used to judge the functional balance state of "Zang-fu regional tissues" in human body.
6 secondary outcomes
Pulse diagnosis information
Time frame: 10minutes
Pittsburgh Sleep Quality Index (PSQI）
Time frame: 5minutes
Hamilton Anxiety Scale (HAMA)
Time frame: 5minutes
Hamilton Depression Scale (HAMD)
Time frame: 5minutes
Gastrointestinal Symptom Scale
Time frame: 5minutes
Grade table of main disorders of liver and spleen
Time frame: 5minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia and Chronic Gastritis, run by Liyun He 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 11 inclusion and 8 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 28 Dec 2022. 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. 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 Liyun HE, Dr. (13581770875, hely3699@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure measurement in both arms (time frame: 5minutes). 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 28 Dec 2022.