NCT05584046

A Single-blind RCT to Investigate the Effect of a Novel Herbal Patch for the Treatment of PF

Effect of a Novel Herbal Patch for the Treatment of Plantar Fasciitis - A Single-blind Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Disorders and injuries of tendons and ligaments are some of the most diagnosed musculoskeletal (MS) disorders clinically. Nearly half of the 33 million MS disorders reported in the United States each year are tendon and ligament injuries. Although most of such injuries are non-fatal, they are severely debilitating, resulting in significant reduction in patient's quality of life, loss of productivity, and considerable costs to the healthcare system. Among all tendon and ligament disorders and injuries, tendon and ligament overuse disorders are the most common and incapacitating ones. Tendinopathy is a painful tendon overuse disorder, which increases with population aging. It has been estimated that about 30% of consultations for MS complaints in a general practice were related to tendinopathy. The affected tendon is presented with local tenderness, swelling and pain, causing physical disability of the affected individual. The affected tendon degenerates and finally ruptures. Common sites of tendinopathy include supraspinatus, common wrist extensor, flexor tendon, patellar tendon, and Achilles tendon. The outcomes of both conservative treatments and surgeries are not satisfactory, with recurrent pain and tendon retear after surgery. Plantar fasciitis is a chronic painful, degenerative condition of the plantar fascia. It is caused by repetitive traumas at its origin on the calcaneus. Plantar fascia is a thick, ribbon-like fibrous ligament that connects the medial calcaneal tubercle to the heads of the metatarsal bones. It contributes to the support of the foot arch by acting as a tie-rod, where it undergoes tension when the foot bears weight. Therefore, although plantar fascia is anatomically defined as a ligament, it functions similar to a tendon. This study aims to conduct a randomized controlled study to test the efficacy of CDAM patch for the treatment of plantar fasciitis in patients.

Conditions

• Plantar Fasciitis

Interventions

Type	Name	Description
OTHER	CDAM	Novel drugs such as Traditional Chinese Medicine (TCM) formula that can suppress inflammation may augment tissue healing and reduce activity-related pain in patients suffering from plantar fasciitis. Our team has experiences of using TCM for the treatment of plantar fasciitis. Based on our previous experience, our group has developed a new proprietary topical TCM herbal formula, CDAM, containing Carthami Flos , Dipsaci Radix , Aconiti Lateralis Radix Praeparata and Herba Menthae for the treatment of plantar fasciitis.

Timeline

• Start date: 2023-09-20
• Primary completion: 2025-05-31
• Completion: 2025-06-30
• First posted: 2022-10-18
• Last updated: 2024-02-15

Locations

1 site across 1 country: Hong Kong