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

Sponsor
Lo-Sheng Sanatorium (Other)
Overall Status
Recruiting
CT.gov ID
NCT05047809
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
6.9
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: "Jingchuang Ointment"(JCO)
  • Other: Regular Treatment
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Evaluation of Treatment of Leprosy Wounds With Traditional Chinese Herbal Medicine Complex "Jingchuang Ointment"
Actual Study Start Date :
Aug 7, 2021
Anticipated Primary Completion Date :
Mar 5, 2022
Anticipated Study Completion Date :
Mar 5, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: "Jingchuang Ointment"(JCO) group

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)

Other: "Jingchuang Ointment"(JCO)
Applied once a day on the wounds
Other Names:
  • Chuang Song Zong Pharmaceutical Co., Ltd. (Taiwan)

    		•
    Other: Regular treatment group

    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.

    Other: Regular Treatment
    Do not use the "Jingchuang Ointment"(JCO), as the regular treatment as usual.

    Outcome Measures

    Primary Outcome Measures

    1. The size of wound area [Changes in wound size in 3 months]

      Length times width

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Hanson's patients

    • Meet the definition of chronic wound

    Exclusion Criteria:

    • Kidney disease

    • Parathyroid disease

    • Malignant tumors.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lo-Sheng Sanatorium Taoyuan City Taiwan 33351

    Sponsors and Collaborators

    • Lo-Sheng Sanatorium

    Investigators

    • Principal Investigator: Wei-Hung Hsu, Lo-Sheng Sanatorium

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Hsu Wei Hung, Director of chinese medicine, Lo-Sheng Sanatorium
    ClinicalTrials.gov Identifier:
    NCT05047809
    Other Study ID Numbers:
    • TYGH110014
    First Posted:
    Sep 17, 2021
    Last Update Posted:
    Sep 17, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hsu Wei Hung, Director of chinese medicine, Lo-Sheng Sanatorium
    Leprosy
    Hansen's disease (HD)
    Jinchuang Ointment (JCO)
    wounds
    anti-inflammation
    Additional relevant MeSH terms:
    Leprosy
    Wounds and Injuries

    Study Results

    No Results Posted as of Sep 17, 2021