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Effectiveness of 5% calendula extract cream compared with 1% silver sulfadiazine cream on wound healing in patients with pressure ulcers : A phase II randomized controlled trial

Effectiveness of 5% calendula extract cream compared with 1% silver sulfadiazine cream on wound healing in patients with pressure ulcers : A phase II randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251016003
Enrollment
48
Registered
2025-10-16
Start date
2024-11-21
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Pressure Ulcer Chronic Wound Wound Healing Calendula officinalis Silver sulfadiazine Herbal medicine Randomized controlled trial Elderly patients Anti inflammatory agents Wound care Traditional medicine

Interventions

Participants will receive 5% calendula extract cream, manufactured by Thai Herbal Products Co., Ltd., in 100 g tubes. The product is standardized and quality-controlled with GMP PIC/S certification, I
Experimental Drug,Active Comparator Drug
Calendula,sulfadiazine

Sponsors

Office of the Thailand Science Research and Innovation (TSRI)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 55 to 75 years 2.Patients who are willing to participate and able to provide written informed consent 3.Patients who are mentally competent and able to communicate and understand instructions 4.Patients with pressure ulcers up to stage 3 severity 5.Patients assessed by a physician as requiring non surgical treatment and without signs of active infection

Exclusion criteria

Exclusion criteria: 1.Patients currently receiving systemic antibiotic therapy either orally or intravenously for wound treatment 2.Patients with cancer at any stage 3.Patients with uncontrolled diabetes defined as HbA1c greater than 7.5 4.Patients with diabetic complications

Design outcomes

Primary

MeasureTime frame
Wound healing score Day 7, 14, 21, 28, 35, 42,49, 56, 63, and 70 Pressure Ulcer Scale for Healing (PUSH TOOL)

Secondary

MeasureTime frame
complication Day 7, 14, 21, 28, 35, 42,49, 56, 63, and 70 yes/no

Countries

Thailand

Contacts

Public ContactNusriya Mooktaree

Division of Complementary and Alternative Medicine, Department of Thai Traditional and Alternative Medicine ,Ministry of Public health

nusriya.km@gmail.com025917007

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026