Clinical trial · Interventional
Effect of Alpha-lipoic Acid on Regression of Low-grade Squamous Intraepithelial Lesions (LSIL)
Effect of Alpha-lipoic Acid Supplementation on Regression of Low-grade Squamous Intraepithelial Lesions (LSIL)-Double Blind, Randomized, Placebo-controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Low-grade squamous intraepithelial lesions (LSIL) are premalignant changes on the cervix that can lead to malignant changes, i. e. cervical cancer. Alpha-lipoic acid is a fatty acid that is naturally found in food, and due to its proven antioxidant and anti-inflammatory effects, it is increasingly used as a dietary supplement, most often to alleviate the symptoms of various neuropathic conditions. The purpose of this study was to demonstrate efficiency, safety, and clinical benefit of alpha lipoic acid (ALA) in inducing regression of LSIL. The hypothesis is based on the proven role of oxidative stress and inflammation in formation of LSIL and anti-inflammatory and antioxidative efficiency of ALA. The study was designed as randomized, double-blind, two-arm, placebo-control trial recruiting 100 female patients with diagnosed LSIL. Patients received 600 mg/day of ALA or placebo for 3 months. Progression/regression of LSIL has been defined as primary outcome of the study; inflammation markers and oxidative stress parameters have been defined as secondary outcomes of the study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low-Grade Squamous Intraepithelial Lesions | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DL-alpha lipoic acid | Dietary Supplement | — | UNRESOLVED |
| placebo (rice starch) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DL-alpha lipoic acid
- description
- 600 mg (2x300 mg) of DL-alpha lipoic acid in capsules, per os daily for 3 months
- interventionNames
- Dietary Supplement: DL-alpha lipoic acid
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 600 mg (2\*300 mg) of placebo (rice starch) in capsules, per os, daily for 3 months
- interventionNames
- Other: placebo (rice starch)
Primary outcomes (1)
- measure
- Regression of Low-Grade Squamous Intraepithelial Lesions (LSIL)
- timeFrame
- baseline to week 12
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * histological confirmation of a low degree of LSIL, * sexually active women. Exclusion Criteria: * pregnancy * malignant diseases * diabetes * chronic inflammatory diseases * hysterectomy * destructive therapy of the cervix * abortion * HPV vaccination * menopause
References
Publications (0)
Data not yet available