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| ID | Type | Description | Link |
|---|---|---|---|
| NMRR ID-25-01261-KS3 | Other Identifier | National Medical Research Register by National Institutes of Health , Ministry of Health Malaysia |
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| Name | Class |
|---|---|
| BREGO Life Sciences Sdn Bhd | INDUSTRY |
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Carpal Tunnel Syndrome (CTS) is a common condition that causes numbness, tingling, pain, and weakness in the hand due to compression of the median nerve at the wrist. It can affect daily activities, work performance, and quality of life. While surgery is effective in severe cases, many patients with mild to moderate CTS are initially treated with non-surgical options such as splinting and medications. However, the effectiveness of oral supplements for CTS remains uncertain.
This clinical study aims to evaluate whether an oral combination of alpha-lipoic acid, Vitamin E, and Vitamin B complex can safely reduce symptoms and improve hand function in patients with Carpal Tunnel Syndrome. These supplements are believed to have antioxidant, anti-inflammatory, and nerve-protective properties, which may help reduce nerve irritation and improve nerve recovery.
Participants in this study will be randomly assigned to receive either the oral supplement combination or a comparator treatment. The study is single-blinded, meaning participants will not know which treatment they are receiving. Symptoms such as pain, numbness, and hand function will be assessed over a defined follow-up period using clinical evaluation and standardized questionnaires.
The main hypothesis of this study is that patients receiving the oral combination of alpha-lipoic acid, Vitamin E, and Vitamin B will experience greater improvement in symptoms and functional outcomes compared to those who do not receive the combination, without significant side effects.
The results of this study may help determine whether this oral supplement combination can be used as an effective and safe conservative treatment option for patients with Carpal Tunnel Syndrome, potentially reducing the need for invasive procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Antioxidant Supplement Group | Experimental |
| |
| Control Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha-Lipoic Acid, Vitamin E, and Vitamin B Complex | Dietary Supplement | An oral dietary supplement containing a combination of alpha-lipoic acid, Vitamin E, and Vitamin B complex administered once daily for the study duration. The supplement is provided in capsule form and is intended to support nerve health through antioxidant and neuroprotective effects in patients with Carpal Tunnel Syndrome. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score | The Boston Carpal Tunnel Questionnaire (BCTQ) is a patient-reported tool used to assess symptom severity and functional status in carpal tunnel syndrome. It consists of two subscales, with each item scored from 1 (no symptoms or difficulty) to 5 (most severe symptoms or inability). The final score is calculated as the mean of responses, ranging from 1 to 5. Lower scores indicate better outcomes, while higher scores indicate more severe symptoms and functional impairment. | Baseline to 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity Measured by Visual Analog Scale | The Visual Analog Scale (VAS) is used to assess pain intensity. It is a continuous scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst imaginable pain. Patients are asked to rate their pain based on this scale. Higher scores indicate greater pain severity | Baseline to 12 and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nurhakim Bin Ibrahim, MBBCH | Contact | +60123170898 | nurhakimibrahim@gmail.com | |
| ASSOCIATE PROFESSOR ABDUL NAWFAR BIN SADAGATULLAH | Contact | +6097676378 | 6378 | nawfar@usm.my |
| Name | Affiliation | Role |
|---|---|---|
| nurhakim bin ibrahim | Hospital Pakar Universiti Sains Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Pakar Universiti Sains Malaysia | Recruiting | Kubang Kerian | Kelantan | 16150 | Malaysia |
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| Combination Vitamin B1,B6,B12 | Dietary Supplement | An oral Vitamin B complex supplement administered once daily for the study duration. This intervention serves as the active comparator for conservative treatment of Carpal Tunnel Syndrome. |
|
| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| D014810 | Vitamin E |
| D014803 | Vitamin B Complex |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014815 | Vitamins |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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