Clinical trial NCT06467851: Effect of Suanzaoren Decoction and Huanglian Wendan Decoction on Biorhythm of Insomnia Patients
Official title: An Interventional Clinical Study to Investigate the Effect of Oral Administration of Suanzaoren Decoction and Huanglian Wendan Decoction on Human Biorhythms in Patients With Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Melatonin
Circadian Rhythm
Suanzaoren Decoction and Huanglian Wendan
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to examine the impact of Chinese medicine on melatonin levels in patients with insomnia

Detailed description: This was a single-centre, non-randomised, interventional study with a planned enrolment of 20 subjects, including 10 Chinese insomnia patients and 10 healthy subjects. All subjects giving written informed consent. Healthy subjects were admitted to the study ward at baseline (D-3), completed the Pittsburgh Sleep Quality Index (PSQI), Morning and Evening Questionnaire (MEQ), and began saliva collection at 16:00, stayed overnight in the study ward that night and were discharged the following day (D-2). Insomnia patients were admitted to the study ward at baseline (D-3), completed the PSQI and MEQ questionnaires and started saliva collection at 16:00, stayed overnight in the study ward and left the following day (D-2) after completing the relevant examinations. After 4 weeks of treatment with Suanzaoren Decoction and Huanglian Wendan Decoction, the subject was re-admitted to the study ward on D30, completed the PSQI and MEQ questionnaires and started saliva collection at 16:00, stayed overnight in the study ward and left on the following day (D31) after completing the relevant examinations. The intervention for patients with insomnia in this study was the administration of Suanzaoren Decoction and Huanglian Wendan Decoction twice a day for 4 weeks. Add or subtract Chinese herbal medicine according to the different clinical manifestations of each patient.

Eligibility criteria: Inclusion Criteria:

* Age 18-55, male or female；
* Insomnia patients: patients who met the diagnostic criteria for insomnia in the Chinese Guidelines for the Diagnosis and Treatment of Insomnia in Adults (2017 edition) and who were judged to have moderate-to-severe insomnia according to the Insomnia Severity Index Scale; Healthy subjects: those who had normal sleep, and who met the scores of 0 to 7 on the Insomnia Severity Index Scale;
* Informed consent, voluntary participation in the study；

Exclusion Criteria:

* People with mental illness;
* Chronic insomnia with yang deficiency and yin deficiency, clinical manifestations: coldness of the whole body and hands and feet, like warmth and pressing, yellowish colour, unshaped stools, lumbago, weakness of the legs, nocturia, pale tongue with thin white moss;
* Pregnant, lactating women;
* Have a serious primary heart, liver, lung, kidney, haematological or serious disease affecting their survival, e.g. tumour or AIDS, SCr \> 1.5N (N is the upper limit of normal), ALT \> 2N (N is the upper limit of normal), blood leucocytes \< 3.0 x 109/L;
* Participants in any other clinical trial within 3 months prior to dosing;
* Those who are vulnerable to missing visits based on other circumstances that the researcher judges to be unsuitable for enrolment, such as changes in the work environment.

Primary outcomes:
measure: Changes from Baseline in melatonin concentration at Week 4
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at 4 weeks
timeFrame: Baseline and Week 4
measure: Change from Baseline in the total score of Morning and Evening Questionnaire (MEQ) at 4 weeks
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiuqin Wang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Feng Shao, doctor
role: PRINCIPAL_INVESTIGATOR
References: