Clinical study on topical herbal creams in burn wound

Development of three-pronged strategy for burn wound management using plant extracts and enzymes - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062816

Enrollment

Registered

2024-02-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: T202- Burn of second degree of head, face, and neck

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with burn wound of any etiology 2. Patient with 5 to 10 percent of burned surface area 3. Patients with second degree burns. 4. Subjects willing to sign informed consent and to undergo all the study procedure

Exclusion criteria

Exclusion criteria: 1. Known allergy or hypersensitivity reaction to epidermal growth factor, silver sulfadiazine or other substances in formulation. 2. Burn wound involving the eyes, ears, nose, mouth & genitals 3. Pregnancy or breastfeeding 4. No underlying diseases that interfere wound healing such as known chronic kidney disease, liver disease, immunocompromised conditions. 5. Treatment with another investigational drug or other intervention (within a specified time frame) 6. History of drug or alcohol abuse 7. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with patient’s participation in, and completion of the study

Design outcomes

Primary

Measure	Time frame
Comparative difference in time required (in days) for complete healing of burn woundTimepoint: Baseline visit, every alternate day visit till complete healing of burn wound	—

Secondary

Measure	Time frame
1. Comparative evaluation of wound healing process by comparing the mean surface area (percentage healing) of burn wound 2. Comparative assessment of wound discharge, smell, color of burn area, pain during dressing, burning pain at rest, edema, granulation tissue, itching and pigmentation 3. Global assessment for overall change by investigator and subjects 4. Assessment of adverse events. Timepoint: Baseline visit, every alternate day visit till complete healing of burn wound	—

Measure

Time frame

1. Comparative evaluation of wound healing process by comparing the mean surface area (percentage healing) of burn wound 2. Comparative assessment of wound discharge, smell, color of burn area, pain during dressing, burning pain at rest, edema, granulation tissue, itching and pigmentation 3. Global assessment for overall change by investigator and subjects 4. Assessment of adverse events. Timepoint: Baseline visit, every alternate day visit till complete healing of burn wound

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Countries

India

Contacts

Public ContactDr Bela Nabar

Smt Chandibai Himathmal Mansukhani College

belamsn23@gmail.com9322760417

Outcome results