Loading search results

Outcome Measures

Primary Outcomes (2)

Change in Weight (Unit: Kg)
Mean percentage change in Body Weight in the overweight and Obese Class - I population (Males and Females) between the treatment and placebo group
Day 1 (inclusion) to 45 Days
Change in BMI (Unit: Kg/m2)
Mean percentage change in BMI in the overweight and Obese Class - I population (Males and Females) between the treatment and placebo group
Day 1 (inclusion) to 45 Days

Secondary Outcomes (16)

Percentage of subjects loosing weight
From baseline (i.e. Day 1) to Day 21, Day 45
Change in Hip, Waist, and Thigh Circumference
From baseline (i.e. Day 1) to Day 21, Day 45
Change in total Body fat
From baseline (i.e. Day 1) to Day 21, Day 45
Change in random blood sugar
From baseline (i.e. Day 1) to Day 21, Day 45
Change in HbA1C
From baseline (i.e. Day 1) to Day 45
+11 more secondary outcomes

Study Arms (3)

Phaseolean (White Kidney Bean Standardized Extract)1500 mg Capsules

EXPERIMENTAL

Phaseolus Vulgaris L. is rich in alpha-amylase and alpha-glucosidase inhibitor. It has been used for calories absorption through preventing or delaying the digestion of complex carbohydrate.

Other: Phaseolean (White Kidney Bean Standardized Extract) 1500 mg Capsules

Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules

EXPERIMENTAL

Phaseolus Vulgaris L. is rich in alpha-amylase and alpha-glucosidase inhibitor. It has been used for calories absorption through preventing or delaying the digestion of complex carbohydrate.

Other: Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules

Placebo (Resistant Dextrin) Capsules

PLACEBO COMPARATOR

Interventions

Phaseolean (White Kidney Bean Standardized Extract) 1500 mg CapsulesOther

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.

Phaseolean (White Kidney Bean Standardized Extract)1500 mg Capsules

Phaseolean (White Kidney Bean Standardized Extract)3000 mg CapsulesOther

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.

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, INVESTIGATOR

Masking Details

Subjects will be randomly assigned in a 1:1:1 ratio to receive either treatment A or B or C. The randomization code will be generated by NovoBliss Research. The randomization schedule will be maintained under controlled access. Double Blind will be followed. The Investigator/Evaluator will be blinded to the randomization schedule. The sequence number as per the randomization schedule will be used as Randomization ID. Subjects will be randomly allocated to one of the three treatment groups, as per the randomization code. Neither the subject nor the Investigator/Evaluator shall be aware of the treatment allocation (Double Blind). To maintain blinding, the study staff who involves in treatment dispensing and distribution will not be involved in any other study-related activities.

Purpose

SUPPORTIVE CARE

Intervention Model

PARALLEL

Model Details: Randomized, Three-arm, Comparative, Double-blinded, Placebo-controlled, Single-center, Dose-response, Safety and Efficacy

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Principal Investigator - Medical Director

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)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (16)

Study Arms (3)

Phaseolean (White Kidney Bean Standardized Extract)1500 mg Capsules

Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules

Placebo (Resistant Dextrin) Capsules

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (16)

Study Arms (3)

Phaseolean (White Kidney Bean Standardized Extract)1500 mg Capsules

Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules

Placebo (Resistant Dextrin) Capsules

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations