Clinical trials

Background: With the rising popularity of long-distance running in Hong Kong, running-related injuries have become more common, particularly patellofemoral pain syndrome (PFPS), which is one of the most prevalent conditions among endurance runners. PFPS can negatively affect training consistency, race performance, and long-term participation. While exercise therapy is the primary intervention, patient adherence and long-term outcomes remain limited. Traditional Chinese Medicine ointment (TCMO, Ng's formula) has shown anti-inflammatory and tissue-repairing properties, making it a promising adjunct therapy for PFPS. Objective: 1. To evaluate the efficacy and safety of selected topical agents used in Traditional Chinese Medicine on PFPS in long-distance runners. 2. To assess the impact of these topical agents on running performance in PFPS patients. Methods: A randomized, controlled, parallel-group, single-blinded trial will be conducted with 50 participants. Group A will receive TCMO combined with exercise therapy, while Group B will receive exercise therapy alone. The intervention lasts four weeks, with weekly follow-ups to monitor adherence. Primary outcomes include Kujala Scale (AKPS), eccentric step-down test, and fastest finishing time of recorded race distances. Safety will be monitored through participant reports and exclusion of individuals with contraindications.

B. Introduction Tennis elbow, medically termed lateral epicondylitis (LE), is a prevalent musculoskeletal disorder characterized by pain and tenderness over the lateral epicondyle of the humerus. Excessive mechanical stress on the elbow tendons, often caused by repetitive movements or manual labor, contributes to microtrauma and cumulative strain of the forearm and elbow musculature. Clinically, the site of maximal tenderness is situated just anterior and distal to the lateral epicondyle itself. Moreover, studies have demonstrated that pain intensity and grip strength are closely associated with manual test outcomes in chronic tennis elbow, further supporting the functional relevance of these diagnostic measures. Although historically associated with racquet sports, contemporary evidence indicates that the condition is more frequently linked to occupational and daily activities such as typing, carpentry, and healthcare work.Epidemiological studies estimate an annual prevalence of approximately 1.3% and an incidence of 3.4 per 1,000 individuals, making it one of the most common causes of elbow pain in adults aged 30-60 years. The disorder exerts a considerable impact on modern life. Participants often experience reduced grip strength and functional limitations that interfere with essential tasks such as lifting, writing, or using tools. This functional impairment contributes to work productivity loss and increased healthcare utilization, resulting in substantial economic burden. Moreover, lifestyle factors such as smoking and repetitive manual work has been shown to negatively influence prognosis, with a subset of participants requiring surgical intervention after six months of unsuccessful conservative treatment. Collectively, these findings underscore that tennis elbow is not merely a sports-related injury but a significant occupational health issue, affecting individual well-being and societal efficiency in today's workforce. A pilot randomize controlled cross-over trial of TCMO (Ng's prescription) in 2024 has significant efficacy on LE and can effectively improve the pain symptoms of participants (95%CI: -22.4 to -5.28, p: 0.0032). Modern drug treatments for tennis elbow mainly focus on reducing pain and inflammation. While this can provide short-term relief and help participants tolerate daily activities or rehabilitation, it often does not address the underlying tendon degeneration and impaired healing. C. Trial Objective 1. Primary objective: To evaluate the efficacy of TCMO (Ng's prescription) in reducing pain intensity of LE through randomized controlled trial (RCT). 2. Secondary objective: To evaluate safety of TCMO (Ng's prescription) of LE through randomized controlled trial (RCT). To assess functional improvement of TCMO (Ng's prescription) (PRTEE). Randomization and allocation concealment To minimize research bias, 48 participants will be assigned to two treatment groups and a control group in a 1:1 ratio. Block randomization via Sealed Envelope tool, with gender as the stratification criterion. Sealed opaque envelopes and password-protected file. RA generates sequence; Research Assistant II (RAII) blinded. To further minimize potential bias, evaluators and data analysts involved in the study will be blinded to treatment assignments. RAII will manage and analyze collected data. The PI will assess participant outcomes and oversee the entire study process. Group A: receive Topical Chinese Medicine Ointment (TCMO)（Ng's prescription）and eccentric exercise Group B: receive eccentric exercise only

Background: Lateral epicondylitis (LE), also referred to as lateral elbow tendinopathy and tennis elbow, is commonly seen clinically as an orthopedic disease. Joint manipulations is a common LE treatment, which mainly decrease pain and increases range of motion (ROM). This greatly improve the quality of life of LE patients. The selected Traditional Chinese Medicine (TCM) manipulation is created by Prof. Ng Zhong Neng and clinically used in treating LE for more than 20 years. To date, there is no statistical demonstration regarding the safety and effectiveness of this technique. Consequently, this clinical trial is designed to provide the first systematic evaluation of the technique's efficacy and safety. Objective: To evaluate the efficacy and safety of selected TCM elbow manipulation in treating LE. Methods: A clinical trial will enroll 40 eligible patients diagnosed with LE who meet the inclusion criteria. They will be randomized into two groups, having 20 participants in each group. Group A will receive an exercise program and a manipulation treatment of Mill's manipulation. Meanwhile, Group B will receive the same exercise program and the selected TCM manipulation. Patient Related Tennis Elbow Evaluation (PRTEE), ROM of wrist and forearm, and pain free grip strength (PFGS) of the affected elbow will be evaluated at the beginning and after the last of intervention in this clinical trial. Treatment effect and sequence effect will be analyze with a linear-mixed effect model by Jamovi (2.7.17).

The prevalence of diabetes in China is a significant concern. In 2019, 116.4 million adults were living with diabetes, a number expected to climb to 147.2 million by 2045. Type 2 diabetes (T2D) constitutes 95% of these cases . In Hong Kong, T2D affects an estimated 700,000 people, with prevalence keeps rising. Epidemiology data clearly show that obesity and T2D are closely associated. A previous study conducted by the investigators found that integrin-β2 protein levels are significantly increased in the circulating small extracellular vesicles (sEVs) of obese/overweight individuals. Given the well-known association between integrin/ECM and the development of insulin resistance, The study hypothesis is that integrin-β2 and ECM1 proteins in the circulating sEVs can be used for the early detection of obese individuals at risk for T2D.This proposed study is critical to provide supporting data for the implementation of a subsequent prospective cohort study to validate whether integrin β2/ECM1 proteins in circulating sEVs can be used for the early detection of obese individuals at risk for T2D.

Depression is a common mental health issue in older adults, often manifesting as insomnia, low mood, vague somatic complaints, cognitive decline, and recurrent thoughts of death or suicide. Even subthreshold depressive symptoms in late life significantly impair quality of life. In Hong Kong, recent data show high prevalence of depressive symptoms among community-dwelling older adults (43.7% in men, 54.8% in women), underscoring the urgent public health and economic need for effective interventions. Although the previous evidence has shown that BDJ and GT consumption can improve depressive symptoms, gut microbiota, and QoL respectively, the feasibility and effect of the combination of two intervention approaches in older adults remain unclear. Therefore, the proposed study aims to (1) determine the feasibility of a 12-week blended BDJ and GT consumption program among Hong Kong community-dwelling older adults with depressive symptoms in a small-scale sample, and (2) examine the effects of the blended BDJ and GT consumption program on their depressive symptoms, gut-microbiota and QoL compared with that in the active control group.

This is a randomized, double-blinded, placebo-controlled clinical trial aimed at evaluating the efficacy and safety of Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF) for non-alcoholic fatty liver.

The current study, JC Project MuSE, is a multi-year project aimed at initiating transformative changes in the lives of young learners in schools with a lower socio-economic background through the integration of music and sports education. The research project posits that engaging in structured music and sports programmes can lead to significant improvements in educational performance through the enhancement of executive functions. The research further explores the longitudinal effects of continuous music and sports training, examining the impact of these interventions on developing a greater sense of appreciation for these activities in these young learners. This research is a 3-year study that examines theoretical underpinnings, methodological approaches, and the impact of music and sports interventions to empower youth in schools of lower socio-economic background and promote holistic development through the synergistic effects of sports and music education.

Background In Bangladesh, many children do not get enough opportunities for active play because safe play spaces are limited, school culture often prioritises academic success over physical activity, and many families have safety concerns about outdoor play. These factors reduce the time children spend being active, despite the fact that active play is known to be crucial for children's healthy growth and development. Active play helps children move more, stay physically fit, and develop important social and emotional skills such as teamwork, confidence, and enjoyment. It also supports motor skill development, which includes basic skills like running, jumping, throwing, and catching. The lack of active play in everyday life suggests a strong need for school based programs that can safely introduce regular, structured, and enjoyable physical activity opportunities for children. Objective The main objective of this study is to find out whether a school based active play program can help children increase their daily physical activity, reduce the amount of time they spend sitting, and improve their sleep patterns. The study also aims to examine whether the program improves children's fundamental movement skills, such as running, jumping, throwing, and catching. Methods This study will use a randomised controlled trial design. Randomisation will be at the school level to ensure fairness and reduce bias. This study will test a 12-week school-based AP programme designed to help primary school children in Bangladesh be more active, sit less, sleep better, and improve their basic movement skills. The study will involve eight primary schools, with each school acting as one cluster. Four schools will receive the AP programme and the remaining four will continue their usual routine. About 43 children from each school will join, giving a total sample of around 343 students. Eligibility Criteria Children can take part if they are students at a primary school, healthy, staying in their school for at least six months, able to understand basic Bengali or English, and are Bangladeshi citizens. Children will not be included if they are outside the age range, not attending school, or regularly involved in organised sports, dance, or athletic training. These rules help ensure that the programme is safe and that the comparison between the AP group and the control group is fair. Intervention Description The AP programme will run twice a week for 60 minutes. Each session will include 30 minutes of free play where children choose their own games and 30 minutes of researcher-led guided play. Activities will help children practise running, jumping, throwing, catching, and other fundamental skills. Weekly themes will keep the sessions enjoyable. Students will earn activity points for being active during sessions, reducing screen time at home, and following healthy sleep routines. Each week, the top three "Active Champions'' from every school will receive a small reward. Orientation Sessions Before the programme begins, orientation sessions will be held for parents, teachers, and children. Parents will learn how to support safe play at home, especially when outdoor play is limited due to dengue or safety concerns. They will also receive tips on reducing screen time and encouraging good sleep habits. Teachers will be trained to integrate active breaks, organise movement-friendly classrooms, use outdoor areas safely, and give feedback to students. Children will learn why active play is important and how it can help their health, learning, confidence, and friendships. Data Collection Plan Data will be collected at three time points: before the programme (T1), immediately after 12 weeks (T2), and eight weeks later (T3). Researchers will collect questionnaire responses, measure height, weight and use wrist-worn accelerometers to measure physical activity, sitting time, and sleep. Teachers and parents will help children wear the devices correctly and keep usage records. Fundamental motor skills will be assessed using the (Test of Gross Motor Development) TGMD 3 tool. Data Analysis Researchers will check all data for accuracy and compare results between the AP and control groups. The study will examine changes in PA, sedentary behaviour, sleep patterns, and FMS. It will also explore whether age, gender, or family background affects how children respond to the programme. The results will help determine whether the AP programme is practical for Bangladeshi schools and effective in improving children's movement behaviours and FMS. Expected Results It is expected that children who participate in the AP program will show clear improvements in PA levels, movement skills, sitting time, and sleep patterns compared with children in the control group. Schools may also learn simple and low-cost ways to support children's activity within limited time and space, making the program valuable beyond the study itself.

This is a prospective, cross-sectional study aim to include 1000 patients with urinary incontinence and 100 healthy controls in Hong Kong. The overall objection is to address the gaps in epidemiological profiles, TCM syndrome differentiation, and biomarkers discovery of urinary incontinence among older women. The specific aims including: 1. To assess the epidemiological characteristics of urinary incontinence among older women, as well as patients' knowledge and healthcare-seeking barriers, and to explore factors influencing the disease subtypes, severity, and healthcare-seeking behaviors; 2. To establish diagnostic criteria for traditional Chinese medicine (TCM) syndrome differentiation of urinary incontinence, and analyze the distribution of TCM syndromes; 3. To explore diagnostic biomarkers and severity evaluation biomarkers for three subtypes of urinary incontinence (SUI, UUI, MUI).

This single-arm, open-label pilot clinical trial will test the hypothesis that S-2196, a Chinese herbal medicine formula, will show efficacy and safety in alleviating the amount and frequency of urinary incontinence in female individuals with stress urinary incontinence. All participants (n=15) will receive 1 week of screening, 2 weeks of intervention, and 1 week of follow-up.

This study will employ a randomized controlled trial design to investigate the effects of a brief behavioral intervention that includes (1) self-recording of a regularity-focused sleep diary, (2) 10 strategies for maintaining sleep regularity, and (3) a sleep education information sheet on the maintenance of sleep regularity in young adults during the Christmas break.

Osteoporosis is an age-related disease, characterized by a decreased bone mass and an increased risk of fragility fractures. Osteoporosis leads to increasing mortality, disabilities, morbidity of chronic pain, and the cost of health and social care, as well as decreasing the quality of life from reduced independence and hindered physical, mental, and social well-being. A recent review and meta-analysis, investigating the association between physical activity and osteoporosis prevention in elderly people, indicated that the traditional exercise interventions (i.e., resistance training) were undertaken for 60+ mins, 2-3 times/week for 7+ months. However, participation rates remain low in these exercise programs among older adults, in part due to a need for specialized equipment and correct techniques to prevent injury. In addition, low motivation and associated compliance with such conventional exercise is problematic among older adults. Considering there is little evidence of HIIT benefits related to older women with osteopenia, the current study aims to evaluate the effectiveness of a 24-week HIIT intervention on bone mineral density, bone turnover markers and other health-related outcomes among Hong Kong Chinese older women.

Frailty is a common clinical syndrome that is becoming increasingly important as populations age worldwide. Individuals who are frail are at a higher risk for negative outcomes, such as falls, disability, hospitalizations, and even death. The understanding of frailty has evolved from a straightforward concept to a complex model that includes physical, psychological, cognitive, and social factors. Since frailty is not static and can change over time, early interventions can be beneficial. Nevertheless, research in this area has been challenging due to a lack of agreement on what frailty encompasses and an inadequate understanding of how its different components interact. Defining frailty as a multidimensional issue is essential to recognize the adverse effects that can arise from medical, psychological, and social influences. However, recent studies have not sufficiently addressed how these different aspects work together or developed effective multidimensional interventions.

In this study, a 12-week pragmatic, randomized, double-blinded clinical trial will be conducted to evaluate the efficacy of acupuncture for the treatment of long Covid neuropsychiatric symptoms and provide reference for clinical non-drug treatment.

This single-arm, open-label pilot clinical trial will test the hypothesis that SCD-2101, a Chinese herbal medicine formula, will have efficacy in alleviating constipation in elderly individuals with functional constipation. All participants (n=14) will receive 2 weeks of intervention and 2 weeks of follow-up.

This is a single-arm design. A total of 15 Type 2 Diabetes Mellitus (T2DM) patients with comorbid Metabolic Syndrome (MetS) will be recruited from community. The intervention will be a 4-week of Chinese Herbal Medicine granules treatment, which will consist of six Chinese herbs. The primary outcome measure will be fasting plasma glucose and blood pressure. Secondary outcome measures including changes of anthropometric data (body mass index, waist-to-hip ratio), lipid panels (total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein), HbA1C, Framingham Stroke Risk Score (FSRS), Audit of diabetes-dependent quality of Life (ADDQoL), International Physical Activity Questionnaire Short Form (IPAQ-SF), daily step count and physiological parameters from wearable watch, dietary record, retinal and sublingual vein imaging, concurrent medications and adverse events.