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

ConditionInsomnia

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorShanghai 7th People's Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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 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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Ningshen Danxiang Donkey-hide Gelatin Medicated PasteExperimental treatment 1 intervention

Group B: Ningshen Danxiang Agar Medicated Paste (agar as excipient)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

Insomnia Severity Index (ISI)

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.

Time frame

Baseline, Week 4, Week 8

Change in Daily Total Sleep Time(TST)

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)

Time frame

Baseline, Week 4, Week 8

Change in Sleep Onset Latency (SOL)

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

Time frame

Baseline, Week 4, Week 8

Change in Wake After Sleep Onset (WASO)

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

Time frame

Baseline, Week 4, Week 8

Other outcomes

Incidence of Shanghuo Symptoms

Record the occurrence of symptoms such as dry mouth, soreness in the mouth and tongue, swollen and painful gums, excessive hunger and appetite, and constipation.

Time frame

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

Vital Signs (Body Temperature)

Vital signs are monitored as a key safety parameter to evaluate the physiological tolerability and potential adverse effects of the investigational treatment. Body temperature (°C) is measured under standardized conditions (rest ≥5 minutes, using calibrated equipment) by trained study personnel.

Time frame

Baseline, Week 8

Vital Signs (Pulse Rate)

Vital signs are monitored as a key safety parameter to evaluate the physiological tolerability and potential adverse effects of the investigational treatment. Pulse rate (beats per minute, bpm) is measured under standardized conditions (rest ≥5 minutes, using calibrated equipment) by trained study personnel.

Time frame

Baseline, Week 8

Vital Signs (Respiratory Rate)

Vital signs are monitored as a key safety parameter to evaluate the physiological tolerability and potential adverse effects of the investigational treatment. Respiratory rate (breaths per minute) is measured under standardized conditions (rest ≥5 minutes, using calibrated equipment) by trained study personnel.

Time frame

Baseline, Week 8

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai 7th People's Hospital

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Collaborator

DongE E Jiao Coporation Limited

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: