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NCT05404217
Clinical Trial to Investigate the Efficacy and Safety of LN-OS-22 on Oxidative Stress and Systemic Inflammation in Overweight and Obese Population.
NA trial testing LN-OS-22 in Oxidative Stress in 64 participants. Completed in 13 March 2023.
13 March 2023
Quick facts
| Lead sponsor | Vedic Lifesciences Pvt. Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 64 |
| Start date | 16 June 2022 |
| Primary completion | 13 March 2023 |
| Estimated completion | 13 March 2023 |
| Sites | 3 locations across India |
Drugs / interventions tested
- LN-OS-22
- Maltodextrin (MALTODEXTRIN) — full drug profile →
Conditions studied
- Oxidative Stress — all drugs for Oxidative Stress →
Sponsor
Vedic Lifesciences Pvt. Ltd. — full company profile →
Who can join
Adults 30 to 60, any sex, with Oxidative Stress. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The present clinical investigation has been proposed to further substantiate the evidence of the antioxidant and anti-inflammatory activity of the extract in the healthy adult population with BMI ranging from ≥25.0 kg/m2 and ≤ 34.9 kg/m2 . The antioxidant effect of the 56 days of oral administration of the extract (1000 mg/day) will be primarily assessed by change in the level of 8-isoprostane from baseline to the end of the study and the anti-inflammatory activity of the extract will be investigated by the change in the level of CRP and IL-6. In addition, the effect on lipid peroxidation and DNA damage will be assessed by serum level of MDA before and after 2 months of extract administration. Further, metabolic endotoxemia will be assessed by the change in the plasma level of lipopolysaccharides. Weight and waist circumference are included as secondary outcomes as the clinical indicators of reduction in oxidative stress and inflammation. Overweight and obesity significantly impact the health-related quality of life31 in the affected individuals and flavonoids have previously been shown to improve the quality of life in controlled clinical studies therefore, Investigator included health-related quality of life as a secondary objective of the study. The safety of the 2-month administration of the extract will be examined by a change in the vitals, liver, and kidney function biomarkers (SGOT, SGPT, ALP, and creatinine).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effect of SophorOx<sup>®</sup> on Oxidative Stress and Body Composition in Individuals with High BMI: A Randomized Controlled Trial.
Roza JM, Srivastava S. · · 2024 · cited 1× · PMID 38854444 · DOI 10.2147/dmso.s452451
Verify or expand the search:
- PubMed search for NCT05404217
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05404217 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vedic Lifesciences Pvt. Ltd.
- Last refreshed: 6 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05404217.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing