An interventional study of Suanzaoren Decoction and Huanglian Wenda Decoction in Chronic Insomnia, Melatonin and Circadian Rhythm, sponsored by The First Affiliated Hospital with Nanjing Medical University. Completed at 2 sites in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment
The purpose of this study was to examine the impact of Chinese medicine on melatonin levels in patients with insomnia
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.
1,925 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.
This study's enrollment of 19 is below the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 563 studies on the registry; 311 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Healthy subjects completed questionnaires and underwent saliva collection
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.
Changes from Baseline in melatonin concentration at Week 4
The level of melatonin in the body
Time frame: Baseline and Week 4
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)
Time frame: 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
Time frame: Baseline and Week 4
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sleep Initiation and Maintenance Disorders →
The First Affiliated Hospital with Nanjing Medical University →