BedsoresNCT07761078
Jingwanhong for Bedsores
An observational study of Bedsores, run by Tianjin University of Traditional Chinese Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bedsores
- What is being tested?
- Jingwanhong Ointment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll long-term bedridden patients aged over 18 years with an expected survival of at least 3 months and an anticipated bed rest duration exceeding 1 month. Eligible participants must have a clinically diagnosed pressure injury (Stage I-IV), based on the diagnostic and staging criteria from the NPUAP/EPUAP/PPPIA Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline (2019). Patients will additionally be classified by traditional Chinese medicine (TCM) syndrome type-Qi Stagnation and Blood Stasis, Toxin Accumulation with Putrefaction, or Qi-Blood Deficiency-according to the 2019 guideline issued by the China Association of Chinese Medicine. All participants must voluntarily agree to join the study and provide signed informed consent. Patients will be excluded if they have a known allergy or hypersensitivity to any component of Jingwanhong Ointment, have a diagnosed psychiatric disorder, present with a wound showing malignant transformation or
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Real-World Post-Marketing Re-evaluation Study of Jingwanhong Ointment for Pressure Injuries in Long-Term Bedridden Patients
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.
Read more
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.
- Conditions
- Bedsores
- Being tested
- Jingwanhong Ointment
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jingwanhong OintmentDrug
Also called Jingwanhong Ruangao
A topical compound traditional Chinese medicine ointment composed of multiple herbal ingredients, applied externally to the wound surface to promote tissue repair and wound healing in patients with pressure injuries.
| Study group | Role | What they receive |
|---|---|---|
| Exposed Cohort: Jingwanhong Ointment | Participants in this cohort are defined as long-term bedridden patients with pressure injuries who receive treatment with Jingwanhong Ointment.
Product specification: Jingwanhong Ointment, manufactured by Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd.
Dosage and administration: The wound surface is first cleansed with normal saline. An appropriate amount of Jingwanhong Ointment is then applied directly to the wound, or spread onto sterile gauze, which is placed over the wound and covered with a sterile dressing. Dressings are changed once daily. Receives: Drug: Jingwanhong Ointment | |
| Non-Exposed Cohort: Standard Care only | Participants in this cohort are defined as long-term bedridden patients with pressure injuries who do not receive treatment with Jingwanhong Ointment. These participants receive standard wound care per routine clinical practice at the study site, without the use of Jingwanhong Ointment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Time (from intervention to complete epithelialization of the wound)
Healing time is defined as the time from initiation of wound treatment to complete epithelialization of the wound surface. This outcome is determined by visual inspection: the wound is considered epithelialized when it is completely covered by epithelial tissue with no obvious exudate or tenderness/inflammatory signs. The time from treatment initiation to complete epithelialization is recorded as the healing time. This measure reflects the speed and efficiency of wound healing. The wound will be assessed daily, and the date of first complete epithelialization will be recorded. If the wound heals completely within 4 weeks, follow-up will be terminated early and the actual healing time recorded; if not healed, observation will continue until the study endpoint at 8 weeks.
Measured: 8weeks
Complete Wound Healing Rate
The original wound area is first recorded, typically by tracing the wound outline on a transparent film and calculating the area. After treatment, the remaining unhealed wound area is similarly measured using transparent film tracing and area calculation. The wound healing rate is then calculated using the formula: Wound Healing Rate = (Original Wound Area - Unhealed Wound Area) / Original Wound Area × 100%. This measure provides a direct reflection of the degree of wound healing after 4 weeks of treatment. Assessments will be performed weekly from the start of treatment until the end of follow-up.
Measured: Weekly assessments up to the end of follow-up (8 weeks)
Secondary outcomes (2)
Visual Analog Scale (VAS) for Pain
Pain levels will be assessed and compared between the two groups of patients with pressure injuries using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, with lower scores indicating reduced pain intensity. The wound will be assessed daily, and the date of first complete epithelialization will be recorded. If the wound heals completely within 4 weeks, follow-up will be terminated early and the actual healing time recorded; if not healed, observation will continue until the study endpoint at 8 weeks.
Measured: 8weeks
Pressure Ulcer Scale for Healing (PUSH)
Wound healing status will be assessed and compared between the two groups using the Pressure Ulcer Scale for Healing (PUSH). The scale evaluates three dimensions-wound area, exudate amount, and tissue type-with a total score ranging from 0 to 17 points; lower scores indicate better healing. Assessments will be performed weekly from the start of treatment until the end of follow-up.
Measured: 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BedsoresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, TIANYI ZHAO ,MD, Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761078
- Sponsor's protocol ID
- 25JCLZJC00170
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Post-Marketing Re-evaluation Study of Jingwanhong Ointment for Pressure Injuries in Long-Term Bedridden Patients
- ClinicalTrials.gov ID
- NCT07761078
- Acronym / sponsor ID
- 25JCLZJC00170
- Conditions
- Bedsores
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed Cohort: Jingwanhong Ointment | – | Drug: Jingwanhong OintmentParticipants in this cohort are defined as long-term bedridden patients with pressure injuries who receive treatment with Jingwanhong Ointment. Product specification: Jingwanhong Ointment, manufactured by Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. Dosage and administration: The wound surface is first cleansed with normal saline. An appropriate amount of Jingwanhong Ointment is then applied directly to the wound, or spread onto sterile gauze, which is placed over the wound and covered with a sterile dressing. Dressings are changed once daily. |
| Non-Exposed Cohort: Standard Care only | – | –Participants in this cohort are defined as long-term bedridden patients with pressure injuries who do not receive treatment with Jingwanhong Ointment. These participants receive standard wound care per routine clinical practice at the study site, without the use of Jingwanhong Ointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll long-term bedridden patients aged over 18 years with an expected survival of at least 3 months and an anticipated bed rest duration exceeding 1 month. Eligible participants must have a clinically diagnosed pressure injury (Stage I-IV), based on the diagnostic and staging criteria from the NPUAP/EPUAP/PPPIA Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline (2019). Patients will additionally be classified by traditional Chinese medicine (TCM) syndrome type-Qi Stagnation and Blood Stasis, Toxin Accumulation with Putrefaction, or Qi-Blood Deficiency-according to the 2019 guideline issued by the China Association of Chinese Medicine. All participants must voluntarily agree to join the study and provide signed informed consent. Patients will be excluded if they have a known allergy or hypersensitivity to any component of Jingwanhong Ointment, have a diagnosed psychiatric disorder, present with a wound showing malignant transformation or
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jingwanhong OintmentAlso: Jingwanhong RuangaoA topical compound traditional Chinese medicine ointment composed of multiple herbal ingredients, applied externally to the wound surface to promote tissue repair and wound healing in patients with pressure injuries. | Drug | Exposed Cohort: Jingwanhong Ointment |
Primary outcome
Healing Time (from intervention to complete epithelialization of the wound)
Time frame: 8weeks
Healing time is defined as the time from initiation of wound treatment to complete epithelialization of the wound surface. This outcome is determined by visual inspection: the wound is considered epithelialized when it is completely covered by epithelial tissue with no obvious exudate or tenderness/inflammatory signs. The time from treatment initiation to complete epithelialization is recorded as the healing time. This measure reflects the speed and efficiency of wound healing. The wound will be assessed daily, and the date of first complete epithelialization will be recorded. If the wound heals completely within 4 weeks, follow-up will be terminated early and the actual healing time recorded; if not healed, observation will continue until the study endpoint at 8 weeks.
Complete Wound Healing Rate
Time frame: Weekly assessments up to the end of follow-up (8 weeks)
The original wound area is first recorded, typically by tracing the wound outline on a transparent film and calculating the area. After treatment, the remaining unhealed wound area is similarly measured using transparent film tracing and area calculation. The wound healing rate is then calculated using the formula: Wound Healing Rate = (Original Wound Area - Unhealed Wound Area) / Original Wound Area × 100%. This measure provides a direct reflection of the degree of wound healing after 4 weeks of treatment. Assessments will be performed weekly from the start of treatment until the end of follow-up.
2 secondary outcomes
Visual Analog Scale (VAS) for Pain
Time frame: 8weeks
Pressure Ulcer Scale for Healing (PUSH)
Time frame: 8weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Bedsores, run by Tianjin University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tianyi Zhao M.D. (+8613820642091, zhaotianyi89@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing Time (from intervention to complete epithelialization of the wound) (time frame: 8weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.