Effect of Suanzaoren Decoction and Huanglian Wendan Decoction on Biorhythm of Insomnia Patients (NCT06467851) | Clinical Trial Compass
CompletedNot Applicable
Effect of Suanzaoren Decoction and Huanglian Wendan Decoction on Biorhythm of Insomnia Patients
China19 participantsStarted 2023-08-31
Plain-language summary
The purpose of this study was to examine the impact of Chinese medicine on melatonin levels in patients with insomnia
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-55, male or femaleï¼›
* 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 studyï¼›
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.
What they're measuring
1
Changes from Baseline in melatonin concentration at Week 4
Timeframe: Baseline and Week 4
Trial details
NCT IDNCT06467851
SponsorThe First Affiliated Hospital with Nanjing Medical University