Effect of Suanzaoren Decoction and Huanglian Wendan Decoction on Biorhythm of Insomnia Patients

Not Applicable

Completed

• Conditions: Chronic Insomnia; Suanzaoren Decoction and Huanglian Wendan; Circadian Rhythm; Melatonin
• Interventions: Drug: Suanzaoren Decoction and Huanglian Wenda Decoction

• Registration Number: NCT06467851
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Study Timeline

• Study Start: 2023-08-31
• Primary Completion: 2024-04-10
• Study Completion: 2024-04-10
• Status Verified: 2024-06
• Study First Submitted: 2024-06-16
• Study First Submitted QC: 2024-06-20
• Last Update Submitted: 2024-06-20
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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；

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chronic insomnia patients group	Suanzaoren Decoction and Huanglian Wenda Decoction	Questionnaire completion and saliva collection in patients with chronic insomnia before and after Chinese herbal medicine treatment, respectively

Primary Outcome Measures

Name	Time	Method
Changes from Baseline in melatonin concentration at Week 4	Baseline and Week 4	The level of melatonin in the body

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in the total score of Morning and Evening Questionnaire (MEQ) at 4 weeks	Baseline and Week 4	The Morning and Evening Questionnaire (MEQ) was used to evaluate the type of biological clock of subjects
Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at 4 weeks	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)

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China