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A Clinical Safety and Efficacy Study in Subjects With Overweight or Obese Class - I, to Evaluate the Degree of Significant Weight Loss by Regular Intake of Phaseolean (White Kidney Bean Standardized Extract)

NCT05711784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-08-01

No results posted yet for this study

Summary

A randomized, double-blinded, placebo-controlled, single-centre, clinical safety and efficacy study in subjects with overweight or Obese Class - I, to evaluate the degree of significant weight loss by regular intake of Phaseolean (White Kidney Bean Standardized Extract).

This study is dose-response study to evaluate effectiveness of two different dosage i.e. 1500 mg Versus 3000 mg.

22 subjects will be enrolled per test treatment to complete 20 subjects per test treatment.

Conditions

  • Body Weight in the Overweight and Obese Class - I Population

Interventions

OTHER

Phaseolean (White Kidney Bean Standardized Extract) 1500 mg Capsules

Mode of Usage: 2 capsules each time before 3 daily meals for consecutive 45 days. Route of Administration: Oral Administration with a glassful (approx. 250 mL) of water.

OTHER

Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules

Mode of Usage: 2 capsules each time before 3 daily meals for consecutive 45 days. Route of Administration: Oral Administration with a glassful (approx. 250 mL) of water.

OTHER

Placebo (Resistant Dextrin) Capsules

Resistant dextrin is a soluble fiber, derived from wheat or corn starch and is prepared by highly controlled partial hydrolysis and repolymerization of the dextrinization process

Sponsors & Collaborators

  • Ambe Phytoextracts Pvt. Ltd

    collaborator INDUSTRY

  • NovoBliss Research Pvt Ltd

    lead OTHER

Principal Investigators

  • Dr Nayan K Patel, MBBS · Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-22
Primary Completion
2023-04-25
Completion
2023-05-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05711784 on ClinicalTrials.gov