Ning Shen Dan Xiang Gao Fang for Heart-Kidney Disharmony Insomnia

Starting soon · Phase 2

Conditions studied: Insomnia

In brief

The goal of this clinical trial is to learn if Ning Shen Dan Xiang paste combined with Ejiao (donkey-hide gelatin) works better than Ning Shen Dan Xiang paste combined with agar (placebo substitute) to treat chronic insomnia of the heart-kidney disharmony type in adults. It will also assess safety. The main question is: \- Does Ning Shen Dan Xiang + Ejiao improve sleep quality more than the placebo version, as shown by the change in Pittsburgh Sleep Quality Index (PSQI) score after 8 weeks? Researchers will compare the two pastes (identical in appearance and taste except for Ejiao) and use published literature data as an additional external control. Participants will: Take 20 g of the assigned paste twice daily (morning and evening) for 8 weeks. Attend clinic visits at baseline, week 4, week 8, and 1 week after stopping (week 9 follow-up). Complete PSQI and ISI questionnaires, keep a daily electronic sleep diary, provide blood/stool samples, and undergo safety monitoring (blood/urine tests, ECG, vital signs, and side effect checks).

Key facts

Study ID

NCT07504536

Run by

Shanghai 7th People's Hospital

People needed

60

Starts

2026-03-15

Expected to finish

2028-12-31

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets the diagnostic criteria for chronic insomnia and simultaneously meets the diagnostic criteria for heart-kidney disharmony syndrome.
• Pittsburgh Sleep Quality Index (PSQI) total score > 7 points.
• No insomnia treatment medication received within 2 weeks prior to the trial.
• Age > 18 years, gender unrestricted.
• Voluntarily participates in this study, signs the informed consent form, and is willing to take medication on time and undergo follow-up visits.

You may not qualify if…

• Pregnant or lactating women.
• Patients with an allergic constitution or hypersensitivity to multiple drugs.
• Patients with primary diseases of the heart, liver, kidney, respiratory system, nervous system, hematopoietic system, or other systems, who are assessed by the investigator as unsuitable for participation in this study.
• Patients with schizophrenia, bipolar affective disorder, major depressive disorder (Hamilton Depression Rating Scale HAMD17 > 24 points), anxiety disorder (Hamilton Anxiety Rating Scale score ≥ 21 points), or other psychiatric disorders, as well as patients with senile dementia.
• Patients with insomnia induced by drugs, strong coffee/tea, or other substances, or those who have taken Chinese or Western medicines for the treatment of insomnia within 2 weeks prior to enrollment.
• History of alcohol or drug abuse.
• Laboratory abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of the normal range, or creatinine (Cr) > the upper limit of the normal range.
• Patients who have participated in any other clinical trial within the past 3 months.
• Patients whom the investigator considers unsuitable for participation in this clinical trial.

Where it is running

• Shanghai Seventh People's Hospital — Shanghai, Pudong New Area, China

Full record on ClinicalTrials.gov

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