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
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
Treatments tested in this trial
- Ningshen Danxiang Donkey-hide Gelatin Medicated Paste
- Ningshen Danxiang Agar Medicated Paste (agar as excipient)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Shanghai 7th People's Hospital
Lead sponsor
Shanghai University of Traditional Chinese Medicine
Collaborator
DongE E Jiao Coporation Limited
Collaborator
Source ClinicalTrials.gov