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

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

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

Study Overview

• Status: Completed
• Conditions: Circadian Rhythm; Chronic Insomnia; Melatonin; Suanzaoren Decoction and Huanglian Wendan
• Intervention / Treatment: Drug: Suanzaoren Decoction and Huanglian Wenda Decoction

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • The First Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 224000
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Healthy subject group; Healthy subjects completed questionnaires and underwent saliva collection
Experimental: Chronic insomnia patients group; Questionnaire completion and saliva collection in patients with chronic insomnia before and after Chinese herbal medicine treatment, respectively	Drug: Suanzaoren Decoction and Huanglian Wenda Decoction; Twice daily. Chinese herbal medicine 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from Baseline in melatonin concentration at Week 4	The level of melatonin in the body	Baseline and Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline and Week 4
Change from Baseline in the total score of Morning and Evening Questionnaire (MEQ) at 4 weeks	The Morning and Evening Questionnaire (MEQ) was used to evaluate the type of biological clock of subjects	Baseline and Week 4

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Actual): April 10, 2024
• Study Completion (Actual): April 10, 2024

Study Registration Dates

• First Submitted: June 16, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2023-SR-431

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No