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

NCT07504536 | Not Yet Recruiting Phase 2

• 1 other identifier: QY-NSDXGF-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI)

  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.

  Baseline, Week 4, Week 8, Follow-up (Week 9)

Secondary Outcomes (7)

• 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

Other Outcomes (45)

• Incidence of Shanghuo Symptoms

  Week 4, Week 8, Follow-up (Week 9)

• Vital Signs (Body Temperature)

  Baseline, Week 8

• Vital Signs (Pulse Rate)

  Baseline, Week 8

Study Arms (2)

Ningshen Danxiang Donkey-hide Gelatin Medicated Paste

EXPERIMENTAL

Formula Composition: Mori Fructus (Sang Shen / Mulberry fruit) 300 g Ligustri Lucidi Fructus (Nü Zhen Zi / Glossy privet fruit) 300 g Polygoni Multiflori Caulis (Shou Wu Teng / Fleeceflower stem) 300 g Sedum aizoon Herba (Jing Tian San Qi / Aizoon stonecrop) 300 g Salviae Miltiorrhizae Radix et Rhizoma (Dan Shen / Red sage root) 300 g Citri Medica Fructus (Xiang Yuan / Fragrant citron fruit) 100 g Cyperi Rhizoma (Xiang Fu / Nutgrass rhizome) 100 g Asini Corii Colla (E Jiao / Donkey-hide gelatin) 500 g

Drug: Ningshen Danxiang Donkey-hide Gelatin Medicated Paste

Ningshen Danxiang Agar Medicated Paste (agar as excipient)

PLACEBO COMPARATOR

Formula Composition: Mori Fructus (Sang Shen / Mulberry fruit) 300 g Ligustri Lucidi Fructus (Nü Zhen Zi / Glossy privet fruit) 300 g Polygoni Multiflori Caulis (Shou Wu Teng / Fleeceflower stem) 300 g Sedum aizoon Herba (Jing Tian San Qi / Aizoon stonecrop) 300 g Salviae Miltiorrhizae Radix et Rhizoma (Dan Shen / Red sage root) 300 g Citri Medica Fructus (Xiang Yuan / Fragrant citron fruit) 100 g Cyperi Rhizoma (Xiang Fu / Nutgrass rhizome) 100 g Agar 500 g

Drug: Ningshen Danxiang Agar Medicated Paste (agar as excipient)

Interventions

Ningshen Danxiang Donkey-hide Gelatin Medicated Paste DRUG

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 Donkey-hide Gelatin Medicated Paste

Ningshen Danxiang Agar Medicated Paste (agar as excipient) DRUG

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Shanghai 7th People's Hospital: lead
• Innovation Research Institute of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine: collaborator
• Institute of Digestive Diseases, Shanghai University of Traditional Chinese Medicine: collaborator
• Center for Pharmacometrics, Shanghai University of Traditional Chinese Medicine: collaborator
• DongE E Jiao Coporation Limited: collaborator

Study Sites (1)

Shanghai Seventh People's Hospital

Shanghai, Pudong New Area, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Agar; Excipients

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Galactans; Polysaccharides; Carbohydrates; Pharmaceutical Vehicles; Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Xiaodan Zhang, Ph.D

  Shanghai 7th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunyan Zhang, M.D.

CONTACT

021-58670561; zhcy205@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: April 1, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)