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A Double-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 SingleDouble-blind Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05584046
Enrollment
120
Registered
2022-10-18
Start date
2023-09-20
Completion date
2028-12-31
Last updated
2026-08-12

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

Conditions

Plantar Fasciitis

Keywords

Plantar Fasciitis, Herbal Patch

Brief 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.

Interventions

OTHERCDAM

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.

OTHER2% Ketoprofen Patch

MOHRUS patch is the transdermal analgesic anti-inflammatory patch and is a standard treatment prescribed by doctor. Each patch contains 2% Ketoprofen and it is for the relief of pain and inflammation.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Male and female with age 18-70 * Unilateral * Heel pain for more than 6 weeks' duration * VAS score ≥ 5 * Signed informed consent.

Exclusion criteria

* Known chronic disease or receiving long-term medications affecting bone metabolism including BPs * Contraindication to alendronate therapy such as poor dental fitness * ACL injury less than 6 weeks * Injury on duty cases * Patients who have undergone arthroscopy or open surgery in the index knee in the last 12 months * Other associated injuries (fractures and other ligament involvement such as neurovascular bundles injury) * Chondral lesion with concomitant intervention * Presence of X-ray features of osteoarthritis including decrease in joint space, presence of osteophytes and subchondral cysts * Neurological deficit * Pregnant or breastfeeding * Inability to give informed consent

Design outcomes

Primary

MeasureTime frameDescription
Foot Function Index (FFI) questionnaireChange from baseline FFI at 3 weeksThe FFI consists of 23 self-reported items divided into three subscales: limitation, pain and disability. The items are scored on a 10-point Likert scale. For each subscale, the raw score is transformed to a 100-point score, with higher score indicating worse limitation / pain / disability. The total score of FFI is the mean of the subscale scores. The Taiwan Chinese version of FFI has been validated.

Countries

Hong Kong

Contacts

CONTACTPatrick Shu-hang YUNG
patrickyung@cuhk.edu.hk+852 3505 2728

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026