A Phase 2/3 interventional study of Bionerv and Placebo in Carpal Tunnel Syndrome (CTS), sponsored by Universiti Putra Malaysia. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-23.
Sponsored by Universiti Putra Malaysia · Phase 2/3, Interventional, and Treatment
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:
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:
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.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.
This study's enrollment of 70 is above the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Universiti Putra Malaysia is the lead sponsor of 144 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
and/or fulfil the electrodiagnostic criteria of mild to moderate CTS, based on the Padua Scale as defined below:
Exclusion Criteria:
patients with electrodiagnostic criteria of severe or extreme CTS as defined in the Padua scale:
alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg 2 tablets once daily
Drug: Bionerv
maltodextrin, microcrystalline cellulose, tricalcium phosphate, silicon gioxide, magnesium stearate 2 tablets once daily
Drug: Placebo
alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg, 2 tablets once daily
Also known as: Group A
maltodextrin, microcrystalline cellulose, tricalcium phosphate, silicon gioxide, magnesium stearate 2 tablets once daily
Also known as: Group B
Improvement on Nerve Conduction Study
Electrodiagnostic improvement of the median nerve on Nerve Conduction Study (NCS)
Time frame: Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)
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
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)
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
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
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.
Time frame: Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)
Side effects of the treatment and tolerability
The tolerability in this study is based on patient reporting side-effects that developed after taking the medications using a self-administered reporting form. There are no blood or radiological investigation involved to confirm its association with the symptoms.
Time frame: Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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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Universiti Putra Malaysia