Ancient herbal paste put to the test for better sleep
NCT ID NCT07504536
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether a traditional Chinese herbal paste called Ning Shen Dan Xiang Gao Fang, made with donkey-hide gelatin, can improve sleep in adults with chronic insomnia. Sixty participants will take the paste or a placebo twice daily for 8 weeks. Researchers will measure sleep quality using questionnaires and sleep diaries.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ningshen Danxiang Donkey-hide Gelatin Medicated Paste (traditional Chinese herbal paste)
- What this could lead to
- If it works, this could offer a new herbal option for people with chronic insomnia, especially those with a heart-kidney imbalance pattern.
- What could go wrong
- This is a small, early-phase trial with only 60 participants. The placebo effect is strong in insomnia studies, so the results may not be conclusive or widely applicable.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Seventh People's Hospital
Shanghai, Pudong New Area, China
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