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Chronic InsomniaNCT05452577

Treatment of Chronic Insomnia According to Yin Yang Theory and Its Correlation With Circadian Rhythm

A study testing Suanzaoren Decoction and Huanglian Wendan Decoction and Estazolam 1Mg Tab in people with Chronic Insomnia and Circadian Rhythm, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the safety and efficacy of Traditional Chinese medicine (TCM) according to Yin Yang theory for treatment of chronic insomnia . Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Suanzaoren Decoction and Huanglian Wendan Decoction and Estazolam 1Mg Tab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
187 participants
Where
1 siteChina
Study dates
22 Jan 2021to 30 May 2023
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Outpatients or inpatients.
  • It conforms to the chronic insomnia diagnosis standard of Chinese adult insomnia diagnosis and treatment guide (2017 Edition).
  • Chronic insomnia patients with Yin yang imbalance and Ying Wei Disharmony Syndrome.
  • Informed consent, voluntary participation in the study.

Who cannot join

  • Sleep apnea syndrome leads to insomnia.
  • Severe depression, suicidal tendency or having committed suicide.
  • Pregnant and lactating women.
  • It has serious primary heart, liver, lung, kidney, blood or serious diseases affecting its survival, such as: tumor or AIDS, SCR > 1.5n (n is the upper limit of normal value), ALT > 2n (n is the upper limit of normal value), WBC < 3.0 × 109 / L;
  • Those who cannot give full informed consent due to mental disorders.
  • According to the researcher's judgment, other situations that are not suitable for the group, such as the change of working environment.
  • Subjects who are participating in other clinical studies.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 224000

Other trials in China

About this study

Official title: Clinical Normative Evaluation of Chronic Insomnia Treated by Traditional Chinese Medicine According to Yin Yang Theory and Its Correlation With Circadian Rhythm

The purpose of this study is to assess the safety and efficacy of Traditional Chinese medicine (TCM) according to Yin Yang theory for treatment of chronic insomnia .

Read the detailed description

All subjects giving written informed consent. In this multicenter, controlled, prospective cohort study, the outpatient and inpatient chronic insomnia patients' baseline demographic data were collected, including age, gender, education background, and medication history. Venous blood samples were collected and sent to laboratory test for blood routine, and blood biochemistry at Baseline and Week 4. The Pittsburgh sleep quality index (PSQI) was used to assess the patients' sleep quality at baseline and week 4. Objective sleep quality data is assessed by wearing a Sleep wearable devices. The classic Morningness-Eveningness Questionnaire and wearable devices was used to assess the patients' chronotype at baseline and week 4.Subjects who visit the TCM clinic of this project received Suanzaoren Decoction and Huanglian Wendan Decoction orally twice daily for 4 weeks. Add or subtract Chinese herbal medicine according to the different clinical manifestations of each patient. Subjects from TCM clinic who had previously taken Western medicine hypnotics continued taking them, and for those who had not taken before, Western medicine hypnotics shall not be given/prescribed. Subjects who visit the Western medicine clinic of this project received Estazolam 1mg tablet orally once daily for 4 weeks. The participants will have a follow-up visit every two weeks, and the prescription would be adjusted according to the condition of illness.Cessation rate of Western medicine hypnotics was assessed at Month 6.

Being tested
Suanzaoren Decoction and Huanglian Wendan Decoction, Estazolam 1Mg Tab
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.

  • Suanzaoren Decoction and Huanglian Wendan DecoctionDrug

    Also called Wild Jujube Seed Decoction and Huanglian Wendan Decoction

    Twice daily. Chinese herbal medicine includes: includes: 25 grams of Suanzaoren, 10 grams of chuanxiong, 30 grams of fushen, 10 grams of Polygala tenuifolia, 10 grams of Pinellia ternata, 12 grams of tangerine peel, 15 grams of Zhuru, 30 grams of forged keel, 30 grams of forged oyster,10 grams of aurantii fructus, 6 grams of coptis chinensis, 30 grams of Albizzia bark.Add or subtract Chinese herbal medicine according to the different clinical manifestations of each patient.

  • Estazolam 1Mg TabDrug

    Also called Estazolam, Estazolam Tablets, Estazolam Pill

    1mg tablet once daily

Study groups in NCT05452577
Study groupRoleWhat they receive
Chinese medicine groupExperimentalParticipants received Suanzaoren Decoction and Huanglian Wendan Decoction orally twice daily for 4 weeks. Subjects who had previously taken Western medicine hypnotics continued to take them, and those who did not take them did not add Western medicine hypnotics.
Receives: Drug: Suanzaoren Decoction and Huanglian Wendan Decoction
Western medicine groupActive comparatorParticipants received Estazolam 1mg tablet orally once daily for 4 weeks.
Receives: Drug: Estazolam 1Mg Tab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at 4 weeks

    The Pittsburgh sleep quality index (PSQI) is a validated,self-reported instrument assessing the sleep quality over the past 4 week period. Possible scores range from 0(the best sleep quality) to 21(the worst possible sleep) quality).The higher the score of PSQI, the worse the sleep quality. Change=(Month 1 Score-Baseline Score)

    Measured: Baseline and Week 4

  2. Cessation rate of Western medicine hypnotics at Month 6

    Cessation was defined as an absence of any Western medicine hypnotics that was sustained for 3 consecutive months or more. Cessation rate of Western medicine hypnotics=(Month 6 number-Baseline number)/Baseline number of Participants use Western medicine hypnotics.

    Measured: Month 6

Secondary outcomes (7)

  1. Change from Baseline of the ALT at 4 weeks

    Alanine aminotransferase, ALT in U/L

    Measured: Baseline and Week 4

  2. Change from Baseline of the AST at 4 weeks

    Aspartate aminotransferase, AST in U/L

    Measured: Baseline and Week 4

  3. Change from Baseline of the BUN at 4 weeks

    Blood urea nitrogen, BUN in mmol/L

    Measured: Baseline and Week 4

  4. Change from Baseline of the Scr at 4 weeks

    Serum creatinine, Scr in μmol/L

    Measured: Baseline and Week 4

  5. Genome-wide association study

    Illumina HumanHap550-Duo BeadChips was used to perform the whole genome genotyping in deCODE genetics(Reykjavı'k, Iceland)

    Measured: Month 6

  6. Change from Baseline in the score of Morningness-Eveningness Questionaire (MEQ)

    The MEQ is a validated, self-reported questionaire assessing personal chronotype in the recent period. Possible scores range from 16 (extreme eveningness) to 86 (extreme morningness). Change = (Week 4 Score - Baseline Score). Positive score change indicates a shift from eveningness to morningness.

    Measured: Baseline and Week 4

  7. Change from baseline objective sleep quality

    Objective sleep quality data is assessed by wearing a Sleep wearable devices

    Measured: Baseline and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start22 Jan 2021
  3. Primary completion30 May 2023
  4. Study completion30 May 2023

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05452577
Sponsor's protocol ID
2021-SR-015
Status last verified
Feb 2024
First submitted
6 Jul 2022
Last updated
28 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Suanzaoren Decoction and Huanglian Wendan Decoction and Estazolam 1Mg Tab in people with Chronic Insomnia and Circadian Rhythm, run by The First Affiliated Hospital with Nanjing Medical University 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 7 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: finished, as of the sponsor's last update on 28 Feb 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at 4 weeks (time frame: Baseline and Week 4). The study lists 2 primary outcomes in all. 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 NCT05452577.

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 Feb 2024.

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