Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 9:59 AM
Study NCT ID:
NCT06940557
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy And Tolerability Of Alpha Lipoic Acid And Vitamin B Preparation In Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-01', 'size': 559796, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-07T19:07', 'hasProtocol': True}, {'date': '2023-04-01', 'size': 296595, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-04-15T19:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double blind trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-15', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Side effects of the treatment and tolerability', 'timeFrame': 'Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Improvement on Nerve Conduction Study', 'timeFrame': 'Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)', 'description': 'Electrodiagnostic improvement of the median nerve on Nerve Conduction Study (NCS)'}], 'secondaryOutcomes': [{'measure': 'Improvements in symptoms using the Boston Carpal Tunnel Questionnaire (BCTQ)', 'timeFrame': 'Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)', 'description': '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'}, {'measure': 'Improvements in symptoms using the visual analog score (VAS)', 'timeFrame': 'Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)', 'description': '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'}, {'measure': 'Improvements in quality of life using the SF-36 questionnaire', 'timeFrame': 'Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin B', 'Alpha Lipoic Acid', 'CTS', 'NCS', 'BCTQ', 'SF-36', 'VAS'], 'conditions': ['Carpal Tunnel Syndrome (CTS)']}, 'referencesModule': {'references': [{'pmid': '9325471', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19499849', 'type': 'BACKGROUND', 'citation': 'Di 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.'}, {'pmid': '32296475', 'type': 'BACKGROUND', 'citation': 'Passiatore 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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* Does the combination of ALA and vitamin B improve nerve function (based on electrodiagnostic studies) in patients with CTS?\n* Does this treatment reduce CTS-related symptoms and improve quality of life?\n* What side effects, if any, do participants experience while taking the treatment?\n\nResearchers 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.\n\nParticipants will:\n\n* Take the ALA and vitamin B combination or a placebo once daily for 6 months.\n* 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.\n* Receive follow-up phone calls and reminder messages to ensure medication compliance and attendance at scheduled visits.', 'detailedDescription': '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.\n\nDuring 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients with numbness and tingling sensation at the first finger until the radial site of the 4th finger\n* and/or fulfil the electrodiagnostic criteria of mild to moderate CTS, based on the Padua Scale as defined below:\n\n * Mild: abnormal digit/wrist Sensory Nerve Conduction Velocity (CV) and normal Distal Motor Latency (DML)\n * Moderate: abnormal digit/wrist Sensory Nerve Conduction Velocity (SNCV) and abnormal Distal Motor Latency (DML).\n\nExclusion Criteria:\n\n* pregnant or breastfeeding women\n* patients with symptoms of CTS but have normal NCS\n* patients taking traditional or complementary medication for CTS\n* patients with electrodiagnostic criteria of severe or extreme CTS as defined in the Padua scale:\n\n * Severe: Absence of sensory response (SNAP) and abnormal Distal Motor Latency (DML).\n * Extreme: Absence of motor (CMAP) and sensory responses (SNAP).'}, 'identificationModule': {'nctId': 'NCT06940557', 'briefTitle': 'Efficacy And Tolerability Of Alpha Lipoic Acid And Vitamin B Preparation In Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Putra Malaysia'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'JKEUPM-2022-984'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treament', 'description': 'alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg 2 tablets once daily', 'interventionNames': ['Drug: Bionerv']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'maltodextrin, microcrystalline cellulose, tricalcium phosphate, silicon gioxide, magnesium stearate 2 tablets once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bionerv', 'type': 'DRUG', 'otherNames': ['Group A'], 'description': 'alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg, 2 tablets once daily', 'armGroupLabels': ['Treament']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Group B'], 'description': 'maltodextrin, microcrystalline cellulose, tricalcium phosphate, silicon gioxide, magnesium stearate 2 tablets once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43000', 'city': 'Serdang', 'state': 'Selangor', 'country': 'Malaysia', 'facility': 'Hospital Sultan Abdul Aziz Shah', 'geoPoint': {'lat': 3.03333, 'lon': 101.71667}}], 'overallOfficials': [{'name': 'ANNA MISYAIL ABDUL RASHID, NEUROLOGIST', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UPM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Putra Malaysia', 'class': 'OTHER'}, 'collaborators': [{'name': 'BREGO Life Sciences Sdn Bhd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr,', 'investigatorFullName': 'Anna Misyail Abdul Rashid', 'investigatorAffiliation': 'Universiti Putra Malaysia'}}}}