The clinical trial has illustrated the positive influence seed oil of Biota orientalis can have on inflammation and severe knee pain
Research organisation Vedic Lifesciences and Australian-based Nutraceutical company Interpath have jointly presented a study showing the effects of Biota orientalis seed oil on inflammation and knee pain.
The study results were published in the journal Inflammopharmacology in June. The proprietary oil Epiitalis is extracted from Biota orientalis seeds, a popular Chinese herb, and has a proven effect on chondrocyte proliferation and inflammation.
Six clinical study sites in the urban area of India participated in the trial conducted from December 2019 to August 2020. This 8-week study randomised 235 volunteers into 4 arms, including high dose (640 mg Epiitalis daily), mid (320 mg daily), low (160 mg daily) and placebo control. The study had a 7-day run-in period to screen out placebo responders.
Among the mITT population, a significant reduction in the Pain-VAS scores from baseline to the end of the study was observed in all Epiitalis groups versus placebo. All doses of Epiitalis led to similar quantitative beneficial changes in the WOMAC and SF-36 scores. A significantly higher number of OMERACT-OARSI responders were present in the Epiitalis groups.
Epiitalis can be a nice complementary addition to joint health supplements in soft gel form gaining massive popularity
Epiitalis was found to be safe with no adverse events ascribed to the interventions. All three doses of Epiitalis were similarly efficacious. Additional trials with lower Epiitalis doses would be necessary to establish a clear dose response.
All study-related data was captured via a real-time electronic diary. Due to the COVID-19 outbreak midway through the study, participants were instead dispensed with study-related questionnaires and responses collected digitally through video conferencing with the study investigators. Specific logistic arrangements were made for blood sample collection and dispensing of study medications at the participants' homes by Vedic Lifesciences.
The data validation was performed by statistically analysing the baseline data of pre-lockdown and post-lockdown cohorts. No significant differences were observed, providing support that the COVID-19 outbreak and resulting changes in study procedures were unlikely to affect study outcomes.
"We are glad that the study could be successfully completed in the midst of the pandemic and that inflammation and arthritis experts like Peter G. Mitchell, PhD and Shalini Srivastava, MD could be associated with the study design, data analysis and interpretations. We think that Epiitalis can be a nice complementary addition to joint health supplements in soft gel form gaining massive popularity in the international markets," said Corina Bright, General Manager of Interpath.