Level B· Emerging clinical evidence with positive signalsRandomized Controlled TrialEurope PMCOpen access

High-Dose Shilajit Enhances Xenograft-Mediated Bone Regeneration in a Rat Tibial Defect Model: An In Vivo Experimental Study

Guler R., Ozden E., Asır F., Gulsun B.

Randomized Controlled Trial with a reported sample of 7 on Chronic Inflammation, published in Life (Basel) (2025) — summary generated from the PubMed abstract.

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Level B· Emerging clinical evidence with positive signalsEvidence level of this study

Several human studies show positive signals, while research methods and sample sizes continue to develop.

  • Level A · Stronger Clinical Evidence
  • Level B · Emerging clinical evidence with positive signals
  • Level C · Early human research exploring benefits
  • Level D · Scientific groundwork from lab and animal studies
  • Emerging · Emerging topic under active research
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This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.

Study type
Randomized Controlled Trial
Journal
Life (Basel) (2025)
Reported sample size
7
Source database
Europe PMC
PMID
41157202
PMCID
PMC12565024
DOI
10.3390/life15101528
Citations
1

Abstract (original English)

Shilajit, a natural herbo-mineral compound with potent antioxidant, anti-inflammatory, and osteogenic properties, has been traditionally used to promote tissue repair. However, limited experimental data exist on its localized application in bone regeneration. This study aimed to evaluate the combined effect of Shilajit and bovine-derived xenograft on bone healing in a rat tibial defect model. Twenty-eight male Sprague-Dawley rats were randomly assigned to four groups ( n = 7): Control (defect left to heal spontaneously), Graft-only, Graft + Shilajit 150 mg/kg, and Graft + Shilajit 250 mg/kg. Standardized 3 mm tibial defects were created and filled with xenograft in all groups except the Control. Shilajit was administered intraperitoneally on days 0-3 postoperatively. After 4 weeks, serum total oxidant status (TOS), total antioxidant status (TAS), and TNF-α levels were measured. Tibial specimens underwent histopathological, histomorphometric, and TNF-α immunohistochemical analysis. High-dose Shilajit significantly increased TAS and reduced TOS compared with the Control and Graft-only groups ( p p < 0.001). Histomorphometry revealed the highest new bone area percentage (78.1% [74.9-81.2]) and lowest fibrous tissue content (9.8% [8.1-11.6]) in the high-dose group. Immunohistochemistry confirmed marked suppression of TNF-α expression in Shilajit-treated groups, particularly at high

What this study does not prove

  • • This study does not prove SVF is an approved treatment or a replacement for standard care.

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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