Insomnia
Conditions
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.
Interventions
DRUGNingshen 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.
DRUGNingshen 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.
Sponsors
Shanghai 7th People's Hospital
Innovation Research Institute of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine
Institute of Digestive Diseases, Shanghai University of Traditional Chinese Medicine
Center for Pharmacometrics, Shanghai University of Traditional Chinese Medicine
DongE E Jiao Coporation Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | Baseline, Week 4, Week 8 | Use the ISI scale to assess the severity of insomnia in the subjects. This scale consists of 7 questions, each scored from 0 to 4 points (5 grading levels in total). No clinically significant insomnia (i.e., cured): 0 ≤ ISI ≤ 7; mild insomnia: 8 ≤ ISI ≤ 14; moderate insomnia: 15 ≤ ISI ≤ 21; severe insomnia: 22 ≤ ISI ≤ 28. |
| Change in Daily Total Sleep Time(TST) | Baseline, Week 4, Week 8 | Assessed via an Electronic Patient-Reported Outcome (ePRO) daily sleep diary. This measure reports the change in the patient's daily total sleep time. Unit of Measure: Minutes ( or Hours) |
| Change in Sleep Onset Latency (SOL) | Baseline, Week 4, Week 8 | SOL is defined as the time interval from the point the patient attempts to fall asleep until the onset of sleep. Data is recorded daily by patients via an electronic Patient-Reported Outcome (ePRO) sleep diary. Unit of Measure: Minutes |
| Change in Wake After Sleep Onset (WASO) | Baseline, Week 4, Week 8 | Assessed via an electronic Patient-Reported Outcome(ePRO) daily sleep diary. WASO refers to the total amount of time the patient spent awake after initially falling asleep and before fully waking up for the day.Unit of Measure: Minutes |
| Change in Number of Awakenings | Baseline, Week 4, Week 8 | Assessed via an Assessed via an electronic Patient-Reported Outcome(ePRO) daily sleep diary. This measure records the total frequency of nighttime awakenings experienced by the patient after initial sleep onset. Unit of Measure: Count (or Number of awakenings) |
| Traditional Chinese Medicine(TCM) Syndrome Score - Efficacy Evaluation | Baseline, Week 4, Week 8, Follow-up (Week 9) | The TCM symptom grading and quantification criteria include three main symptoms-difficulty falling asleep, vexation and insomnia, and excessive dreaming-which are scored on a 0, 2, 4, or 6 scale according to severity and frequency; the nine secondary symptoms-palpitations, tinnitus, soreness and weakness of the waist and knees, tidal fever with night sweats, vexing heat in the five centers, dry throat, dry mouth, seminal emission in men, and irregular menstruation in women-are scored on a 0-3 scale according to severity and frequency. Tongue and pulse: red tongue tip with scant coating and a thready rapid pulse.The Nimodipine method is used to assess the therapeutic efficacy of TCM syndromes. The syndrome score calculation formula is: ((pre-treatment score - post-treatment score)/pre-treatment score)\*100% Effective: All symptoms and signs show improvement; syndrome score reduction ≥50%; Ineffective: Symptoms and signs show no obvious improvement; syndrome score reduction \<50%. |
| Rebound Insomnia Rate | 1 week after treatment discontinuation | Rebound insomnia is defined as Pittsburgh Sleep Quality Index (PSQI) total score \> baseline score at 1 week following drug discontinuation |
Countries
China
Contacts
CONTACTChunyan Zhang, M.D.
PRINCIPAL_INVESTIGATORXiaodan Zhang, Ph.D
Shanghai 7th People's Hospital
Outcome results
None listed