Jingwanhong for Bedsores (NCT07761078) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Jingwanhong for Bedsores
500 participantsStarted 2026-08-20
Plain-language summary
The goal of this observational study is to learn whether Jingwanhong Ointment (a compound traditional Chinese medicine preparation) can effectively and safely treat pressure injuries (bedsores) in long-term bedridden patients in a real-world clinical setting. The main questions it aims to answer are:
Does treatment with Jingwanhong Ointment improve healing outcomes of pressure injuries in long-term bedridden patients? Is Jingwanhong Ointment safe for use in this patient population? Do patients with different Traditional Chinese Medicine (TCM) syndrome patterns (Qi Stagnation and Blood Stasis, Toxin Accumulation with Rotting Ulceration, and Qi-Blood Deficiency) respond differently to treatment, and which subgroups benefit most? Researchers will use propensity score matching (PSM) and Cox proportional hazards models to control for confounding factors, and will stratify patients by TCM syndrome pattern to explore treatment response and identify patient subgroups most likely to benefit from Jingwanhong Ointment.
Participants who are long-term bedridden and diagnosed with pressure injuries will be enrolled in a prospective, multicenter, real-world cohort at approximately 500 . Participants will:Receive standardized treatment with Jingwanhong Ointment as part of their routine clinical care for pressure injuries.
Be followed over time to assess wound healing outcomes, safety, and treatment response according to their TCM syndrome classification.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 years
* Expected survival ≥ 3 months
* Long-term bedridden patients with an anticipated bed rest duration exceeding 1 month.
* Clinically diagnosed with pressure injury (Stage I-IV), based on the diagnostic and staging criteria defined in the Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline (2019), jointly developed by the National Pressure Ulcer Advisory Panel (NPUAP), the European Pressure Ulcer Advisory Panel (EPUAP), and the Pan Pacific Pressure Injury Alliance (PPPIA). TCM syndrome differentiation will be based on the Clinical Diagnosis and Treatment Guideline for Bedsores in Traditional Chinese Medicine Surgery, issued by the China Association of Chinese Medicine in January 2019, classifying patients into three syndrome types: Qi Stagnation and Blood Stasis, Toxin Accumulation with Putrefaction, and Qi-Blood Deficiency
* Willing to participate in the study and provide signed informed consent
Exclusion Criteria:
* Known allergy or hypersensitivity to any component of Jingwanhong Ointment
* Diagnosed with a psychiatric disorder
* Wound with malignant transformation or fistula formation
* Currently participating in another clinical trial
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Healing Time (from intervention to complete epithelialization of the wound)
Timeframe: 8weeks
2
Complete Wound Healing Rate
Timeframe: Weekly assessments up to the end of follow-up (8 weeks)
Trial details
NCT IDNCT07761078
SponsorTianjin University of Traditional Chinese Medicine