NCT05047809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2021

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2022

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

29 days

First QC Date

August 25, 2021

Last Update Submit

March 12, 2024

Conditions

Keywords

LeprosyHansen's disease (HD)Jinchuang Ointment (JCO)woundsanti-inflammation

Outcome Measures

Primary Outcomes (1)

  • The size of wound area

    Length times width

    Changes in wound size in 3 months

Study Arms (2)

"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)

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.

Other: Regular Treatment

Interventions

Applied once a day on the wounds

Also known as: Chuang Song Zong Pharmaceutical Co., Ltd. (Taiwan)
"Jingchuang Ointment"(JCO) group

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

Regular treatment group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Kidney disease
  • Parathyroid disease
  • Malignant tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lo-Sheng Sanatorium

Taoyuan, 33351, Taiwan

Location

MeSH Terms

Conditions

LeprosyWounds and Injuries

Interventions

Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Mycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Neuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Wei-Hung Hsu

    Lo-Sheng Sanatorium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of chinese medicine

Study Record Dates

First Submitted

August 25, 2021

First Posted

September 17, 2021

Study Start

August 7, 2021

Primary Completion

September 5, 2021

Study Completion

May 5, 2022

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations