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The Effect of "Jinchuang Ointment" (JCO) on the Treatment of Wounds in Patients With Hansen's Disease.

Primary Purpose

Leprosy, Hansen's Disease, Wounds

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
"Jingchuang Ointment"(JCO)
Regular Treatment
Sponsored by
Lo-Sheng Sanatorium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leprosy focused on measuring Leprosy, Hansen's disease (HD), Jinchuang Ointment (JCO), wounds, anti-inflammation

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hanson's patients
  • Meet the definition of chronic wound

Exclusion Criteria:

  • Kidney disease
  • Parathyroid disease
  • Malignant tumors.

Sites / Locations

  • Lo-Sheng SanatoriumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

"Jingchuang Ointment"(JCO) group

Regular treatment group

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

The size of wound area
Length times width

Secondary Outcome Measures

Full Information

First Posted
August 25, 2021
Last Updated
September 14, 2021
Sponsor
Lo-Sheng Sanatorium
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1. Study Identification

Unique Protocol Identification Number
NCT05047809
Brief Title
The Effect of "Jinchuang Ointment" (JCO) on the Treatment of Wounds in Patients With Hansen's Disease.
Official Title
The Evaluation of Treatment of Leprosy Wounds With Traditional Chinese Herbal Medicine Complex "Jingchuang Ointment"
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 7, 2021 (Actual)
Primary Completion Date
March 5, 2022 (Anticipated)
Study Completion Date
March 5, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lo-Sheng Sanatorium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leprosy, Hansen's Disease, Wounds
Keywords
Leprosy, Hansen's disease (HD), Jinchuang Ointment (JCO), wounds, anti-inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"Jingchuang Ointment"(JCO) group
Arm Type
Experimental
Arm Description
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)
Arm Title
Regular treatment group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
"Jingchuang Ointment"(JCO)
Other Intervention Name(s)
Chuang Song Zong Pharmaceutical Co., Ltd. (Taiwan)
Intervention Description
Applied once a day on the wounds
Intervention Type
Other
Intervention Name(s)
Regular Treatment
Intervention Description
Do not use the "Jingchuang Ointment"(JCO), as the regular treatment as usual.
Primary Outcome Measure Information:
Title
The size of wound area
Description
Length times width
Time Frame
Changes in wound size in 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hanson's patients Meet the definition of chronic wound Exclusion Criteria: Kidney disease Parathyroid disease Malignant tumors.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsin-yi Chen
Phone
+886282006600
Ext
2506
Email
ls01120@lslp.mohw.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Hung Hsu
Organizational Affiliation
Lo-Sheng Sanatorium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lo-Sheng Sanatorium
City
Taoyuan City
ZIP/Postal Code
33351
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsin-Yi Chen
Phone
+886282006600
Ext
2506
Email
ls01120@lslp.mohw.gov.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of "Jinchuang Ointment" (JCO) on the Treatment of Wounds in Patients With Hansen's Disease.

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