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Clinical Study to check the Skin Safety and Efficacy of Aloe Wound Healing Ointment for Wound Healing.

A Double-blind, Randomized, Controlled, Interventional Clinical Study to Evaluate the Skin Safety and Efficacy of Aloe Wound Healing Ointment for its Wound Healing Activity. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059901
Enrollment
30
Registered
2023-11-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: R238- Other skin changes

Interventions

Intervention1: Aloe Wound Healing Ointment: Route of Administration: Topical Dosage: 1 FTU Treatment period: Twice daily for 28 days Control Intervention1: Not Applicable: Not Applicable

Sponsors

University of Pretoria
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects who agree to have their wound photographed during the trial. 2. Healthy Male and Female subjects of 18 to 50 years of age. 3. Subjects having acute wounds (less than 24 hours of occurrence). 4. Subjects with superficial skin wound and partial thickness skin wound greater than or equal to 1.0 and less than or equal to 16.0 cm² area. 5. Subjects who can be categorized under Stage I and Stage II wound. 6. Subjects ready to take injection TT before application of study drug. 7. Subjects are willing to make all required study visits. 8. Subjects are willing to follow instructions in the opinion of the Investigator.

Exclusion criteria

Exclusion criteria: 1. Patient having infected wound. 2. Those who are having visceral, bony, spinal injury. 3. Patient with electrical, chemical, burn injuries. 4. Patient suffering from any systemic disease like Diabetes mellitus, tuberculosis, malignant wounds, arterial, varicose ulcer, pressure ulcer, HbsAg, HIV I &II positive and others which according to the investigator can interfere/cause delay in the wound healing process. 5. Patients suffering from non-healing wounds/ulcers, infectious disease will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
1. Healing the wound within 1 to 2 weeks 2. Pain reduction in 1 to 2 weeks 3. No secondary infections in 1 to 2 weeks 4. Assessment of time required (in days) for complete wound healing.Timepoint: Day 1, Day 7, Day 15, Day 22 & Day 29

Secondary

MeasureTime frame
To observe safety and skin tolerability throughout the study. Timepoint: Day 1, Day 7, Day 15, Day 22 & Day 29

Countries

India

Contacts

Public ContactMeena Dalal

TrialGuna Private Limited

drrnsclinic@gmail.com08867125414

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026