Carpal Tunnel Syndrome (CTS)Phase 2/3NCT06940557
Efficacy And Tolerability Of Alpha Lipoic Acid And Vitamin B Preparation In Carpal Tunnel Syndrome
A Phase 2/3 study testing Bionerv in people with Carpal Tunnel Syndrome (CTS), run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
The goal of this clinical trial is to assess the effectiveness and safety of an oral combination of alpha lipoic acid (ALA) and vitamin B complex in treating mild to moderate carpal tunnel syndrome (CTS) in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Bionerv
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2023to 30 Sep 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- all patients with numbness and tingling sensation at the first finger until the radial site of the 4th finger
- and/or fulfil the electrodiagnostic criteria of mild to moderate CTS, based on the Padua Scale as defined below:
- Mild: abnormal digit/wrist Sensory Nerve Conduction Velocity (CV) and normal Distal Motor Latency (DML)
- Moderate: abnormal digit/wrist Sensory Nerve Conduction Velocity (SNCV) and abnormal Distal Motor Latency (DML).
Who cannot join
- pregnant or breastfeeding women
- patients with symptoms of CTS but have normal NCS
- patients taking traditional or complementary medication for CTS
- patients with electrodiagnostic criteria of severe or extreme CTS as defined in the Padua scale:
- Severe: Absence of sensory response (SNAP) and abnormal Distal Motor Latency (DML).
- Extreme: Absence of motor (CMAP) and sensory responses (SNAP).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating The Efficacy And Tolerability Of The Oral Combination Of Alpha Lipoic Acid And Vitamin B Complex Preparation In Carpal Tunnel Syndrome : a Single-center, Randomized, Double-blind, Placebo-controlled Trial.
The goal of this clinical trial is to assess the effectiveness and safety of an oral combination of alpha lipoic acid (ALA) and vitamin B complex in treating mild to moderate carpal tunnel syndrome (CTS) in adults. The main questions it aims to answer are:
- Does the combination of ALA and vitamin B improve nerve function (based on electrodiagnostic studies) in patients with CTS?
- Does this treatment reduce CTS-related symptoms and improve quality of life?
- What side effects, if any, do participants experience while taking the treatment?
Read more
Researchers will compare the combination of ALA and vitamin B to a placebo (a look-alike substance that contains no active drug) to evaluate its effectiveness.
Participants will:
- Take the ALA and vitamin B combination or a placebo once daily for 6 months.
- Attend clinic visits at the start of the study, after 3 months, and after 6 months for physical examinations, nerve conduction studies, and to complete questionnaires about their symptoms and quality of life.
- Receive follow-up phone calls and reminder messages to ensure medication compliance and attendance at scheduled visits.
Read the detailed description
The patients were randomized to receive oral combination of alpha lipoic acid and vitamin B (alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg), 2 tablets once daily or placebo drug (maltodextrin, microcrystalline cellulose, tricalcium phosphate, silicon gioxide, magnesium stearate) 2 tablets once daily. Randomization sequence was done by using an online random number generator program using a mixed block randomization technique at a ratio of 1:1. In cases of serious adverse event, unblinding process was incorporated where the identity of the drug was revealed to manage the subject's condition. This was done by intruding the emergency code key by the researcher. All patients provided a written consent for the study.
During visit 1, a thorough history and physical examination were done, and demographic data was collected. Afterward, the patients were required to answer three sets of self-administered questionnaires: Boston Carpal Tunnel Questionnaire (BCTQ), Visual analogue score (VAS) and SF-36. The BCTQ is a specific questionnaire for assessing CTS that consists of two distinct scales, the Symptom Specific Scale (SSS) which has 11 items and the Functional Status Scale (FSS) containing 8 items. Each scale generates a final score ranging from 1 to 5, with a higher score indicating greater disability and poor symptoms control. BCTQ is a reliable questionnaire to assess CTS owing to its high cross-cultural adaptation and multilingual validity and reliability. The VAS is a visual scale with 0 scored as "no pain" and 10 as "worst pain imaginable" and serves as an excellent tool for pain score with excellent validity and reproducibility. The SF-36 is a quality-of-life questionnaire that comprises of 36 questions covering eight domains of health which are; Physical Functioning (PF), Role Limitations due to Physical Health, Role Limitations (RL) due to Emotional Problems (RE), energy/fatigue, emotional well-being, social functioning, pain, and general health (GH) where a higher score indicates a better outcome . After the administration of these questionnaires, they will be subjected for a nerve conduction study (NCS) to determine the severity of CTS. The NCS were performed by the same trained personnel to ensure consistency and accuracy.
The patients were reassessed at Visit 2 (3 months post-treatment) and Visit 3 (6 months post-treatment). During each visit, they underwent physical examination, NCS, and were required to complete the three sets of questionnaires (BCTQ, VAS, and SF-36). They were also required to fill in the form regarding the side effects of the treatments. The investigators made a phone call and sent reminder message at the 6th and 18th week to ensure compliance, medication adequacy and follow up review. During the study, patients were allowed to undergo the standard of care treatment at our center such as physiotherapy.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Bionerv, Placebo
- Keywords
- Vitamin B, Alpha Lipoic Acid, CTS, NCS, BCTQ, SF-36, VAS
- 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.
BionervDrug
Also called Group A
alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg, 2 tablets once daily
PlaceboDrug
Also called Group B
maltodextrin, microcrystalline cellulose, tricalcium phosphate, silicon gioxide, magnesium stearate 2 tablets once daily
| Study group | Role | What they receive |
|---|---|---|
| Treament | Active comparator | alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg 2 tablets once daily Receives: Drug: Bionerv |
| Placebo | Placebo comparator | maltodextrin, microcrystalline cellulose, tricalcium phosphate, silicon gioxide, magnesium stearate 2 tablets once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement on Nerve Conduction Study
Electrodiagnostic improvement of the median nerve on Nerve Conduction Study (NCS)
Measured: Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)
Secondary outcomes (3)
Improvements in symptoms using the Boston Carpal Tunnel Questionnaire (BCTQ)
The BCTQ is a specific self administered questionnaire for assessing CTS that consists of two distinct scales, the Symptom Specific Scale (SSS) which has 11 items and the Functional Status Scale (FSS) containing 8 items. Each scale generates a final score ranging from 1 to 5, with a higher score indicating greater disability and poor symptoms control. BCTQ is a reliable questionnaire to assess CTS owing to its high cross-cultural adaptation and multilingual validity and reliability
Measured: Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)
Improvements in symptoms using the visual analog score (VAS)
The VAS is a visual scale with 0 scored as "no pain" and 10 as "worst pain imaginable" and serves as an excellent tool for pain scoring with excellent validity and reproducibility
Measured: Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)
Improvements in quality of life using the SF-36 questionnaire
The SF-36 is a quality-of-life is a self administered questionnaire that comprises 36 questions covering eight domains of health: physical functioning (PF), role limitations due to physical health, role limitations (RL) due to emotional problems (RE), energy/fatigue, emotional well-being, social functioning, pain, and general health (GH), where a higher score indicates a better outcome.
Measured: Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Dec 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- BREGO Life Sciences Sdn Bhd
- Responsible party
- Principal investigator, Anna Misyail Abdul Rashid, Universiti Putra Malaysia
- Investigators
- ANNA MISYAIL ABDUL RASHID, NEUROLOGIST, Principal investigator, UPM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940557
- Sponsor's protocol ID
- JKEUPM-2022-984
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) from this study will not be shared to ensure patient confidentiality, as participants did not provide explicit consent for data sharing. Additionally, ethical guidelines, regulatory constraints, and concerns about potential data misuse further limit the feasibility of sharing IPD.
Publications
Padua L, LoMonaco M, Gregori B, Valente EM, Padua R, Tonali P. Neurophysiological classification and sensitivity in 500 carpal tunnel syndrome hands. Acta Neurol Scand. 1997 Oct;96(4):211-7. doi: 10.1111/j.1600-0404.1997.tb00271.x.
PubMed 9325471Di Geronimo G, Caccese AF, Caruso L, Soldati A, Passaretti U. Treatment of carpal tunnel syndrome with alpha-lipoic acid. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):133-9.
PubMed 19499849Passiatore M, Perna A, De-Vitis R, Taccardo G. The Use of Alfa-Lipoic Acid-R (ALA-R) in Patients with Mild-Moderate Carpal Tunnel Syndrome: A Randomised Controlled Open Label Prospective Study. Malays Orthop J. 2020 Mar;14(1):1-6. doi: 10.5704/MOJ.2003.001.
PubMed 32296475
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Efficacy And Tolerability Of The Oral Combination Of Alpha Lipoic Acid And Vitamin B Complex Preparation In Carpal Tunnel Syndrome : a Single-center, Randomized, Double-blind, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT06940557
- Acronym / sponsor ID
- JKEUPM-2022-984
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- Vitamin B, Alpha Lipoic Acid, CTS, NCS, BCTQ, SF-36, VAS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- BREGO Life Sciences Sdn Bhd
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 23 Apr 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.
The goal of this clinical trial is to assess the effectiveness and safety of an oral combination of alpha lipoic acid (ALA) and vitamin B complex in treating mild to moderate carpal tunnel syndrome (CTS) in adults. The main questions it aims to answer are:
- Does the combination of ALA and vitamin B improve nerve function (based on electrodiagnostic studies) in patients with CTS?
- Does this treatment reduce CTS-related symptoms and improve quality of life?
- What side effects, if any, do participants experience while taking the treatment?
Researchers will compare the combination of ALA and vitamin B to a placebo (a look-alike substance that contains no active drug) to evaluate its effectiveness.
Participants will:
- Take the ALA and vitamin B combination or a placebo once daily for 6 months.
- Attend clinic visits at the start of the study, after 3 months, and after 6 months for physical examinations, nerve conduction studies, and to complete questionnaires about their symptoms and quality of life.
- Receive follow-up phone calls and reminder messages to ensure medication compliance and attendance at scheduled visits.
Detailed description
The patients were randomized to receive oral combination of alpha lipoic acid and vitamin B (alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg), 2 tablets once daily or placebo drug (maltodextrin, microcrystalline cellulose, tricalcium phosphate, silicon gioxide, magnesium stearate) 2 tablets once daily. Randomization sequence was done by using an online random number generator program using a mixed block randomization technique at a ratio of 1:1. In cases of serious adverse event, unblinding process was incorporated where the identity of the drug was revealed to manage the subject's condition. This was done by intruding the emergency code key by the researcher. All patients provided a written consent for the study.
During visit 1, a thorough history and physical examination were done, and demographic data was collected. Afterward, the patients were required to answer three sets of self-administered questionnaires: Boston Carpal Tunnel Questionnaire (BCTQ), Visual analogue score (VAS) and SF-36. The BCTQ is a specific questionnaire for assessing CTS that consists of two distinct scales, the Symptom Specific Scale (SSS) which has 11 items and the Functional Status Scale (FSS) containing 8 items. Each scale generates a final score ranging from 1 to 5, with a higher score indicating greater disability and poor symptoms control. BCTQ is a reliable questionnaire to assess CTS owing to its high cross-cultural adaptation and multilingual validity and reliability. The VAS is a visual scale with 0 scored as "no pain" and 10 as "worst pain imaginable" and serves as an excellent tool for pain score with excellent validity and reproducibility. The SF-36 is a quality-of-life questionnaire that comprises of 36 questions covering eight domains of health which are; Physical Functioning (PF), Role Limitations due to Physical Health, Role Limitations (RL) due to Emotional Problems (RE), energy/fatigue, emotional well-being, social functioning, pain, and general health (GH) where a higher score indicates a better outcome . After the administration of these questionnaires, they will be subjected for a nerve conduction study (NCS) to determine the severity of CTS. The NCS were performed by the same trained personnel to ensure consistency and accuracy.
The patients were reassessed at Visit 2 (3 months post-treatment) and Visit 3 (6 months post-treatment). During each visit, they underwent physical examination, NCS, and were required to complete the three sets of questionnaires (BCTQ, VAS, and SF-36). They were also required to fill in the form regarding the side effects of the treatments. The investigators made a phone call and sent reminder message at the 6th and 18th week to ensure compliance, medication adequacy and follow up review. During the study, patients were allowed to undergo the standard of care treatment at our center such as physiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treament | Active comparator | Drug: Bionervalpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg 2 tablets once daily |
| Placebo | Placebo comparator | Drug: Placebomaltodextrin, microcrystalline cellulose, tricalcium phosphate, silicon gioxide, magnesium stearate 2 tablets once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- all patients with numbness and tingling sensation at the first finger until the radial site of the 4th finger
- and/or fulfil the electrodiagnostic criteria of mild to moderate CTS, based on the Padua Scale as defined below:
Key exclusion criteria (6 listed)
- pregnant or breastfeeding women
- patients with symptoms of CTS but have normal NCS
- patients taking traditional or complementary medication for CTS
- patients with electrodiagnostic criteria of severe or extreme CTS as defined in the Padua scale:
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 |
|---|---|---|
| BionervAlso: Group Aalpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg, 2 tablets once daily | Drug | Treament |
| PlaceboAlso: Group Bmaltodextrin, microcrystalline cellulose, tricalcium phosphate, silicon gioxide, magnesium stearate 2 tablets once daily | Drug | Placebo |
Primary outcome
Improvement on Nerve Conduction Study
Time frame: Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)
Electrodiagnostic improvement of the median nerve on Nerve Conduction Study (NCS)
3 secondary outcomes
Improvements in symptoms using the Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)
Improvements in symptoms using the visual analog score (VAS)
Time frame: Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)
Improvements in quality of life using the SF-36 questionnaire
Time frame: Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Background: PubMed 9325471Padua L, LoMonaco M, Gregori B, Valente EM, Padua R, Tonali P. Neurophysiological classification and sensitivity in 500 carpal tunnel syndrome hands. Acta Neurol Scand. 1997 Oct;96(4):211-7. doi: 10.1111/j.1600-0404.1997.tb00271.x.
- Background: PubMed 19499849Di Geronimo G, Caccese AF, Caruso L, Soldati A, Passaretti U. Treatment of carpal tunnel syndrome with alpha-lipoic acid. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):133-9.
- Background: PubMed 32296475Passiatore M, Perna A, De-Vitis R, Taccardo G. The Use of Alfa-Lipoic Acid-R (ALA-R) in Patients with Mild-Moderate Carpal Tunnel Syndrome: A Randomised Controlled Open Label Prospective Study. Malays Orthop J. 2020 Mar;14(1):1-6. doi: 10.5704/MOJ.2003.001.
- Individual participant dataSharing planned: No. The individual participant data (IPD) from this study will not be shared to ensure patient confidentiality, as participants did not provide explicit consent for data sharing. Additionally, ethical guidelines, regulatory constraints, and concerns about potential data misuse further limit the feasibility of sharing IPD.
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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. This study is not recruiting at the moment.
ANNA MISYAIL ABDUL RASHID, NEUROLOGIST principal investigator
UPM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bionerv in people with Carpal Tunnel Syndrome (CTS), run by Universiti Putra 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 23 Apr 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement on Nerve Conduction Study (time frame: Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06940557, which also lists 3 linked publications.
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 2025.