Carpal Tunnel SyndromeNCT07312123
A Study to See Whether Taking a Mix of Vitamins Can Help Adults Recover Better After Surgery for Carpal Tunnel Syndrome
A study testing Alpha-Lipoic Acid, Vitamin E, and Vitamin B Complex and Combination Vitamin B1,B6,B12 in people with Carpal Tunnel Syndrome, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Alpha-Lipoic Acid, Vitamin E, and Vitamin B Complex and Combination Vitamin B1,B6,B12
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteMalaysia
- Study dates
- 8 Dec 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years old
- Subjects with symptoms and physical examination of CTS
- Patients with CTS going for CT release
Who cannot join
- Pregnant or breast-feeding women
- Patients with history of trauma in the dominant hand
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Pakar Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
NURHAKIM BIN IBRAHIM, MEDICAL OFFICER, +60123170898, nurhakimibrahim@gmail.com
ASSOCIATE PROFESSOR DR. ABDUL NAWFAR BIN SADAGATULLAH, +6097676378, nawfar@usm.my
About this study
Official title: Effect of Oral Alpha-Lipoic Acid, Vitamin E, and Vitamin B Combination on Symptoms and Function in Carpal Tunnel Syndrome Following Carpal Tunnel Surgery
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.
Read more
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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Alpha-Lipoic Acid, Vitamin E, and Vitamin B Complex, Combination Vitamin B1,B6,B12
- Keywords
- carpal tunnel syndrome, median nerve compression, vitamin e, peripheral nerve entrapment
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Lipoic Acid, Vitamin E, and Vitamin B ComplexDietary 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.
Combination Vitamin B1,B6,B12Dietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Antioxidant Supplement Group | Experimental | Not described Receives: Dietary Supplement: Alpha-Lipoic Acid, Vitamin E, and Vitamin B Complex |
| Control Group | Active comparator | Not described Receives: Dietary Supplement: Combination Vitamin B1,B6,B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 and 24 weeks
Secondary outcomes (1)
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
Measured: Baseline to 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start8 Dec 2025
- Primary completion8 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- BREGO Life Sciences Sdn Bhd
- Responsible party
- Principal investigator, NURHAKIM BIN IBRAHIM, Hospital Universiti Sains Malaysia
- Investigators
- nurhakim bin ibrahim, Principal investigator, Hospital Pakar Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312123
- Sponsor's protocol ID
- USM/JEPeM/KK/25060535
- Other IDs
- NMRR ID-25-01261-KS3
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Alpha-Lipoic Acid, Vitamin E, and Vitamin B Combination on Symptoms and Function in Carpal Tunnel Syndrome Following Carpal Tunnel Surgery
- ClinicalTrials.gov ID
- NCT07312123
- Acronym / sponsor ID
- USM/JEPeM/KK/25060535
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, median nerve compression, vitamin e, peripheral nerve entrapment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hospital Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- BREGO Life Sciences Sdn Bhd
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 8 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Antioxidant Supplement Group | Experimental | Dietary Supplement: Alpha-Lipoic Acid, Vitamin E, and Vitamin B Complex |
| Control Group | Active comparator | Dietary Supplement: Combination Vitamin B1,B6,B12 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age more than 18 years old
- Subjects with symptoms and physical examination of CTS
- Patients with CTS going for CT release
Key exclusion criteria (2 listed)
- Pregnant or breast-feeding women
- Patients with history of trauma in the dominant hand
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-Lipoic Acid, Vitamin E, and Vitamin B ComplexAn 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. | Dietary supplement | Oral Antioxidant Supplement Group |
| Combination Vitamin B1,B6,B12An 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. | Dietary supplement | Control Group |
Primary outcome
Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score
Time frame: Baseline to 12 and 24 weeks
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.
1 secondary outcome
Change in Pain Intensity Measured by Visual Analog Scale
Time frame: Baseline to 12 and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
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Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
nurhakim bin ibrahim principal investigator
Hospital Pakar Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha-Lipoic Acid, Vitamin E, and Vitamin B Complex and Combination Vitamin B1,B6,B12 in people with Carpal Tunnel Syndrome, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nurhakim Bin Ibrahim, MBBCH (+60123170898, nurhakimibrahim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score (time frame: Baseline to 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.