A Randomized, Double-Blind, Dual-Control (Internal and External) Clinical Study of Ning Shen Dan Xiang Gao Fang in the Treatment of Insomnia (Heart-Kidney Disharmony Type)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Pittsburgh Sleep Quality Index (PSQI)
Study Overview
Brief 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).
Detailed Description
This is a randomized, double-blind, parallel-group clinical trial with internal and external controls to evaluate the efficacy and safety of Ningshen Danxiang Gelatin Formula (Ningshen Danxiang combined with donkey-hide gelatin) compared to Ningshen Danxiang Agar Formula (Ningshen Danxiang combined with agar placebo) in treating insomnia of the heart-kidney disharmony type according to Traditional Chinese Medicine (TCM). The study aims to assess changes in Pittsburgh Sleep Quality Index (PSQI) scores from baseline after 8 weeks of treatment. Sixty adult participants (>18 years) with chronic insomnia, PSQI >7, and meeting TCM criteria for heart-kidney disharmony will be randomized 1:1 to receive either the experimental formula (20g twice daily) or control (20g twice daily) for 8 weeks. External controls will be synthesized from literature data on placebo and standard treatments for insomnia. Key secondary outcomes include Insomnia Severity Index (ISI), TCM syndrome scores, sleep logs via electronic patient-reported outcomes (ePRO)and rebound rates. Safety will be monitored through adverse events, laboratory tests, and vital signs.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 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.
Secondary Outcomes
- Insomnia Severity Index (ISI)(Baseline, Week 4, Week 8)
- Change in Daily Total Sleep Time(TST)(Baseline, Week 4, Week 8)
- Change in Sleep Onset Latency (SOL)(Baseline, Week 4, Week 8)
- Change in Wake After Sleep Onset (WASO)(Baseline, Week 4, Week 8)
- Change in Number of Awakenings(Baseline, Week 4, Week 8)
- Traditional Chinese Medicine(TCM) Syndrome Score - Efficacy Evaluation(Baseline, Week 4, Week 8, Follow-up (Week 9))
- Rebound Insomnia Rate(1 week after treatment discontinuation)
Investigators
Xiaodan Zhang
Chief Physician
Shanghai 7th People's Hospital