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NCT05839444
A Clinical Study to Evaluate the Safety and Tolerability of BioPB-01 in Healthy Adults
NA trial testing BioPB-01 in Metabolic Syndrome in 64 participants. Completed in 12 September 2023.
12 September 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 | 27 April 2023 |
| Primary completion | 12 September 2023 |
| Estimated completion | 12 September 2023 |
| Sites | 2 locations across India |
Drugs / interventions tested
- BioPB-01
- Placebo
Conditions studied
- Metabolic Syndrome — all drugs for Metabolic Syndrome →
Sponsor
Vedic Lifesciences Pvt. Ltd. — full company profile →
Who can join
Adults 25 to 55, any sex, with Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The present study is a randomized, placebo-controlled, parallel-group, double-blind clinical study. Seventy-eight individuals will be screened, and considering a screening failure rate of 20%, approximately 64 participants will be randomized in a ratio of 1:1 to receive either BioPB-01 or Placebo
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05839444
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Vedic Lifesciences Pvt. Ltd. trials
Trials by the same sponsor.
- NCT07141368 — Single Oral Dose Comparative Bioavailability Study of Investigational Product in Healthy Human Subjects Under Fasting Co · NA · not yet recruiting
- NCT07033754 — A Study to Assess the Effect Probiotic Supplement on Immune Health in Teachers Prone to Upper Respiratory Tract Infectio · NA · not yet recruiting
- NCT06917287 — A Clinical Study to Evaluate the Efficacy of Native CT-II® in Individuals With Knee Osteoarthritis · NA · recruiting
- NCT06859346 — A Clinical Study to Assess the Effect of Tisina Complex on Cognitive Health in Individuals With Mild Cognitive Impairmen · NA · completed
- NCT06473246 — A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants. · NA · recruiting
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 NCT05839444 (US National Library of Medicine, public domain)
- 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: 8 February 2024
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/NCT05839444.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing