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

• ClinicalTrials.gov Identifier: NCT05452577
• Recruitment Status: Recruiting
• First Posted: July 11, 2022
• Last Update Posted: July 11, 2022
• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Information provided by (Responsible Party): The First Affiliated Hospital with Nanjing Medical University

Tracking Information

• First Submitted Date: July 6, 2022
• First Posted Date: July 11, 2022
• Last Update Posted Date: July 11, 2022
• Actual Study Start Date: January 22, 2021
• Estimated Primary Completion Date: December 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 6, 2022)

• Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at 4 weeks [ Time Frame: Baseline and Week 4 ]
  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)
• Cessation rate of Western medicine hypnotics at Month 6 [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 6, 2022)

• Change from Baseline of the ALT at 4 weeks [ Time Frame: Baseline and Week 4 ]
  Alanine aminotransferase, ALT in U/L
• Change from Baseline of the AST at 4 weeks [ Time Frame: Baseline and Week 4 ]
  Aspartate aminotransferase, AST in U/L
• Change from Baseline of the BUN at 4 weeks [ Time Frame: Baseline and Week 4 ]
  Blood urea nitrogen, BUN in mmol/L
• Change from Baseline of the Scr at 4 weeks [ Time Frame: Baseline and Week 4 ]
  Serum creatinine, Scr in μmol/L
• Genome-wide association study [ Time Frame: Month 6 ]
  Illumina HumanHap550-Duo BeadChips was used to perform the whole genome genotyping in deCODE genetics(Reykjavı'k, Iceland)
• Change from Baseline in the score of Morningness-Eveningness Questionaire (MEQ) [ Time Frame: Baseline and Week 4 ]
  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.
• Change from baseline objective sleep quality [ Time Frame: Baseline and Week 4 ]
  Objective sleep quality data is assessed by wearing a Sleep wearable devices

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment of Chronic Insomnia According to Yin Yang Theory and Its Correlation With Circadian Rhythm
• Official Title: Clinical Normative Evaluation of Chronic Insomnia Treated by Traditional Chinese Medicine According to Yin Yang Theory and Its Correlation With Circadian Rhythm
• Brief 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 .
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Chronic Insomnia
• Circadian Rhythm
• Traditional Chinese Medicine

Intervention

• Drug: Suanzaoren 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.
  Other Name: Wild Jujube Seed Decoction and Huanglian Wendan Decoction
• Drug: Estazolam 1Mg Tab
  1mg tablet once daily
  Other Names:

  • Estazolam
  • Estazolam Tablets
  • Estazolam Pill

Study Arms

• Experimental: Chinese medicine group

  Participants 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.

  Intervention: Drug: Suanzaoren Decoction and Huanglian Wendan Decoction
• Active Comparator: Western medicine group
  Participants received Estazolam 1mg tablet orally once daily for 4 weeks.
  Intervention: Drug: Estazolam 1Mg Tab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 6, 2022): 186
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2023
• Estimated Primary Completion Date: December 30, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Xiuqin Wang, doctor; +86-25-68306156; xiuqinw@126.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05452577
• Other Study ID Numbers: 2021-SR-015
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: The First Affiliated Hospital with Nanjing Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Xiuqin Wang, doctor; The First Affiliated Hospital with Nanjing Medical University

• PRS Account: The First Affiliated Hospital with Nanjing Medical University
• Verification Date: July 2022