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Clinical Trials in China / NCT07504536
Starting soon Phase 2

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

NCT07504536 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai 7th People's Hospital
Phase
Phase 2
Started
2026-03-15
Last updated
2026-04-01

Condition(s) studied

Insomnia

Investigational drug(s) / intervention(s)

Ningshen Danxiang Donkey-hide Gelatin Medicated PasteNingshen Danxiang Agar Medicated Paste (agar as excipient)

Ningshen Danxiang Donkey-hide Gelatin Medicated Paste: Take 1 bag each time (each bag contains 20 g of crude herbal drug). Dissolve in warm boiled water and take orally, once in the morning and once in the evening. It is optimal to take on an empty stomach. Continue for 8 consecutive weeks. If gastrointestinal discomfort occurs when taken on an empty stomach, it may also be taken after meals.

Ningshen Danxiang Agar Medicated Paste (agar as excipient): Take 1 bag each time (each bag contains 20 g of crude herbal drug). Dissolve in warm boiled water and take orally, once in the morning and once in the evening. It is optimal to take on an empty stomach. Continue for 8 consecutive weeks. If gastrointestinal discomfort occurs when taken on an empty stomach, it may also be taken after meals.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Meets the diagnostic criteria for chronic insomnia and simultaneously meets the diagnostic criteria for heart-kidney disharmony syndrome. 2. Pittsburgh Sleep Quality Index (PSQI) total score \> 7 points. 3. No insomnia treatment medication received within 2 weeks prior to the trial. 4. Age \> 18 years, gender unrestricted. 5. Voluntarily participates in this study, signs the informed consent form, and is willing to take medication on time and undergo follow-up visits. Exclusion Criteria: 1. Pregnant or lactating women. 2. Patients with an allergic constitution or hypersensitivity to multiple drugs. 3. 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. 4. 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. 5. 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. 6. History of alcohol or drug abuse. 7. 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. 8. Patients who have participated in any other clinical trial within the past 3 months. 9. Patients whom the investigator considers unsuitable for participation in this clinical trial.

Primary outcome measure(s)

  • Pittsburgh Sleep Quality Index (PSQI) — Baseline, Week 4, Week 8, Follow-up (Week 9)
    Use the PSQI scale to assess the subjects' sleep quality . The PSQI consists of 7 dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each dimension is scored from 0 to 3 points, with higher scores indicating greater severity of sleep disturbance. The total PSQI score ranges from 0 to 21. A PSQI score \>7 indicates poor sleep quality, while a PSQI score ≤7 indicates good sleep quality.

Trial sites (1)

FacilityCityRegionStatus
Shanghai Seventh People's Hospital Shanghai Pudong New Area

More Shanghai 7th People's Hospital trials in China

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Clinical Efficacy and Mechanism of rTMS Based on dlPFC in the Intervention of Generalized Anxiety Disorder With Insomnia Enrolling by invitation
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07504536 on ClinicalTrials.gov ↗ ← All trials in China