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

NCT06467851 | Completed

• 1 other identifier: 2023-SR-431
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chronic Insomnia; Melatonin; Circadian Rhythm; Suanzaoren Decoction and Huanglian Wendan

Outcome Measures

Primary Outcomes (1)

• Changes from Baseline in melatonin concentration at Week 4

  The level of melatonin in the body

  Baseline and Week 4

Secondary Outcomes (2)

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

  Baseline and Week 4

• Change from Baseline in the total score of Morning and Evening Questionnaire (MEQ) at 4 weeks

  Baseline and Week 4

Study Arms (2)

Healthy subject group

NO INTERVENTION

Healthy subjects completed questionnaires and underwent saliva collection

Chronic insomnia patients group

EXPERIMENTAL

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

Interventions

Suanzaoren Decoction and Huanglian Wenda Decoction DRUG

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.

Chronic insomnia patients group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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；

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (2)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 224000, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Xiuqin Wang, doctor

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Feng Shao, doctor

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: June 21, 2024
• Study Start: August 31, 2023
• Primary Completion: April 10, 2024
• Study Completion: April 10, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)