Can an ancient herbal formula unlock better sleep and weight loss?
NCT ID NCT07754383
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This clinical trial is investigating whether a traditional Chinese medicine formula called Qingxin Jiaotai Decoction (QXJTD) can help adults who have both insomnia and obesity. Participants will receive either the herbal granules or a placebo, along with personalized diet and exercise guidance, for 8 weeks. The study will measure changes in sleep quality, body weight, and body composition to see if the herbal formula adds any benefit beyond lifestyle changes alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Qingxin Jiaotai Decoction (QXJTD), a traditional Chinese medicine herbal formula, combined with a personalized lifestyle intervention (diet and exercise)
- What this could lead to
- If effective, this could offer a new integrative treatment option for people struggling with both insomnia and obesity, potentially improving sleep quality and supporting weight loss.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not be conclusive. The herbal formula may have side effects or interact with other medications, and its benefits over placebo are not yet proven.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2030
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 to 65 years
- 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: * Individuals who meet both diagnostic criteria for sleep disorders and obesity, and have a Pittsburgh Sleep Quality Index (PSQI) score exceeding 7 * Meet the TCM syndrome differentiation criteria for either the heart-kidney disharmony syndrome or the liver-fire disturbing the heart syndrome * Aged 18-65, male or female * Those who can actively cooperate with oral Chinese medicine treatment * Voluntarily accept this study and sign the informed consent form Exclusion Criteria: * Patients with severe cardiovascular and cerebrovascular diseases, hematological system diseases, severe liver and kidney dysfunction, tumors, and other severe organic diseases * Individuals with a history of allergy to the study drug or with an allergic constitution * Women planning to become pregnant, pregnant, or breastfeeding * Currently taking or having taken sedative traditional Chinese patent medicines and simple preparations within 4 weeks prior to enrollment, or having used semaglutide and other GLP-1 receptor agonists or weight-reducing preparations with long-term weight-loss effects within 12 weeks prior to enrollment * Those with severe cognitive dysfunction or unable to take care of themselves and therefore unable to cooperate with the clinical trial protocol * Patients with severe anxiety, depression \[Self-rating Anxiety Scale (SAS) score ≥70, Self-rating Depression Scale (SDS) score ≥73\], mania, schizophrenia, and suicidal tendencies. * Individuals who are severely allergic to PSG electrode patches, or who cannot cooperate with polysomnography (PSG) and heart rate variability (HRV) testing due to work/lifestyle habits
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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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Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Haidian, China
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