LeprosyNCT05047809
The Effect of "Jinchuang Ointment" (JCO) on the Treatment of Wounds in Patients With Hansen's Disease.
A study testing "Jingchuang Ointment"(JCO) and Regular Treatment in people with Leprosy and Hansen's Disease, run by Lo-Sheng Sanatorium at 1 site in Taiwan.
Trial summary
This study aimed to evaluate the effect of a Chinese herb complex "Jinchuang ointment" (JCO) on the treatment of chronic nonhealing wounds in patients with Hansen's disease and its mechanism. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Leprosy, Hansen's Disease, Wounds
- What is being tested?
- "Jingchuang Ointment"(JCO) and Regular Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Aug 2021to 5 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hanson's patients
- Meet the definition of chronic wound
Who cannot join
- Kidney disease
- Parathyroid disease
- Malignant tumors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of Treatment of Leprosy Wounds With Traditional Chinese Herbal Medicine Complex "Jingchuang Ointment"
This study aimed to evaluate the effect of a Chinese herb complex "Jinchuang ointment" (JCO) on the treatment of chronic nonhealing wounds in patients with Hansen's disease and its mechanism.
Read the detailed description
20 patients who were hospitalized at Lo-Sheng Sanatorium, Ministry of Health and Welfare, were recruited. Ulcers were treated in this study using the four-step wound care guidelines, observation, rinsing, cleaning, and dressing, published by the Taiwan Food and Drug Administration. Besides, JCO was applied once a day on the wounds.
Basic data of each case were collected, and a monthly wound record was used to follow the condition of the wound healing of these patients.
- Conditions
- Leprosy, Hansen's Disease, Wounds
- Being tested
- "Jingchuang Ointment"(JCO), Regular Treatment
- Keywords
- Leprosy, Hansen's disease (HD), Jinchuang Ointment (JCO), wounds, anti-inflammation
- Medical subject headings
- Leprosy, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Jingchuang Ointment"(JCO)Other
Also called Chuang Song Zong Pharmaceutical Co., Ltd. (Taiwan)
Applied once a day on the wounds
Regular TreatmentOther
Do not use the "Jingchuang Ointment"(JCO), as the regular treatment as usual.
| Study group | Role | What they receive |
|---|---|---|
| "Jingchuang Ointment"(JCO) group | Experimental | Ulcers were treated in this study using the four-step wound care guidelines, observation, rinsing, cleaning, and dressing, published by the Taiwan Food and Drug Administration. Besides, JCO was applied once a day on the wounds, last 3 months.
"Jingchuang Ointment" (JCO) is made by Chuang Song Zong Pharmaceutical Co., Ltd. (Taiwan) Receives: Other: "Jingchuang Ointment"(JCO) |
| Regular treatment group | Other | Ulcers were treated in this study using the four-step wound care guidelines, observation, rinsing, cleaning, and dressing, published by the Taiwan Food and Drug Administration. Receives: Other: Regular Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The size of wound area
Length times width
Measured: Changes in wound size in 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start7 Aug 2021
- Primary completion5 Sep 2021
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo-Sheng Sanatorium
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hsu Wei Hung, Lo-Sheng Sanatorium
- Investigators
- Wei-Hung Hsu, Principal investigator, Lo-Sheng Sanatorium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047809
- Sponsor's protocol ID
- TYGH110014
- Status last verified
- Mar 2024
- First submitted
- 25 Aug 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Treatment of Leprosy Wounds With Traditional Chinese Herbal Medicine Complex "Jingchuang Ointment"
- ClinicalTrials.gov ID
- NCT05047809
- Acronym / sponsor ID
- TYGH110014
- Conditions
- Leprosy, Hansen's Disease, Wounds
- Keywords
- Leprosy, Hansen's disease (HD), Jinchuang Ointment (JCO), wounds, anti-inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lo-Sheng SanatoriumOther government
- Study start
- 7 Aug 2021 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 17 Sep 2021 (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.
This study aimed to evaluate the effect of a Chinese herb complex "Jinchuang ointment" (JCO) on the treatment of chronic nonhealing wounds in patients with Hansen's disease and its mechanism.
Detailed description
20 patients who were hospitalized at Lo-Sheng Sanatorium, Ministry of Health and Welfare, were recruited. Ulcers were treated in this study using the four-step wound care guidelines, observation, rinsing, cleaning, and dressing, published by the Taiwan Food and Drug Administration. Besides, JCO was applied once a day on the wounds.
Basic data of each case were collected, and a monthly wound record was used to follow the condition of the wound healing of these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Jingchuang Ointment"(JCO) group | Experimental | Other: "Jingchuang Ointment"(JCO)Ulcers were treated in this study using the four-step wound care guidelines, observation, rinsing, cleaning, and dressing, published by the Taiwan Food and Drug Administration. Besides, JCO was applied once a day on the wounds, last 3 months. "Jingchuang Ointment" (JCO) is made by Chuang Song Zong Pharmaceutical Co., Ltd. (Taiwan) |
| Regular treatment group | Other | Other: Regular TreatmentUlcers were treated in this study using the four-step wound care guidelines, observation, rinsing, cleaning, and dressing, published by the Taiwan Food and Drug Administration. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hanson's patients
- Meet the definition of chronic wound
Key exclusion criteria (3 listed)
- Kidney disease
- Parathyroid disease
- Malignant tumors.
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 |
|---|---|---|
| "Jingchuang Ointment"(JCO)Also: Chuang Song Zong Pharmaceutical Co., Ltd. (Taiwan)Applied once a day on the wounds | Other | "Jingchuang Ointment"(JCO) group |
| Regular TreatmentDo not use the "Jingchuang Ointment"(JCO), as the regular treatment as usual. | Other | Regular treatment group |
Primary outcome
The size of wound area
Time frame: Changes in wound size in 3 months
Length times width
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Wei-Hung Hsu principal investigator
Lo-Sheng Sanatorium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Jingchuang Ointment"(JCO) and Regular Treatment in people with Leprosy and Hansen's Disease, run by Lo-Sheng Sanatorium at 1 site in Taiwan.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The size of wound area (time frame: Changes in wound size in 3 months). 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 13 Mar 2024.