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

Official title

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)

Overview

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

• Drug 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.
• Drug 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.

Primary outcome measures

• Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline, Week 4, Week 8, Follow-up (Week 9)]

Secondary outcome measures (7)

• Insomnia Severity Index (ISI) [Time frame: Baseline, Week 4, Week 8]
• Change in Daily Total Sleep Time(TST) [Time frame: Baseline, Week 4, Week 8]
• Change in Sleep Onset Latency (SOL) [Time frame: Baseline, Week 4, Week 8]
• Change in Wake After Sleep Onset (WASO) [Time frame: Baseline, Week 4, Week 8]
• Change in Number of Awakenings [Time frame: Baseline, Week 4, Week 8]
• Traditional Chinese Medicine(TCM) Syndrome Score - Efficacy Evaluation [Time frame: Baseline, Week 4, Week 8, Follow-up (Week 9)]
• Rebound Insomnia Rate [Time frame: 1 week after treatment discontinuation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Seventh People's Hospital — Shanghai

Identifiers

NCT: NCT07504536 · QY-NSDXGF-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗