clinical trial of weight management supplementatio

Not Applicable

Completed

• Registration Number: CTRI/2022/01/039232
• Lead Sponsor: aturedge Beverages Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-08-23
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Obese patients (male/female and aged between 20-45 yrs.)

BMI between 30 - 40 kg/m2

Subjects with or without comorbidities, if comorbidity exists should be on stable prescription and with the following criteria- Hypertension (140/90 mmHg on prescription), Type 2 DM (HbA1C <= 7.5 on prescription)

Willing to provide consent

Willing for follow up

Exclusion Criteria

Subjects with any acute illness requiring immediate medical care.

Subjects with Type I DM/Complicated cardiovascular diseases / HbA1C >= 7.5. / History of TIA, Cerebrovascular accident, stroke or any revascularization.

Known subjects of hepatic failure/inflammation.

Pregnant, breast feeding or planning to become pregnant during the study.

Any other condition which proves subject unfit for the study participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Changes in Body Weight <br/ ><br>2.Changes in BMI <br/ ><br>3.Changes in Quality of life of subjects by IWQOL-Lite score (The Impact of Weight on Quality of Life Questionnaire) in social and emotional aspect <br/ ><br>4.Changes in Eating Disorder examination questionnaire score <br/ ><br>5.Changes in energy audit questionnaire score <br/ ><br>Timepoint: screening , baseline and day 60 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Changes in digestive behavior (Bloating, Heartburn, Flatulence, Constipation, Post Prandial Fullness etc.) in subjects <br/ ><br>2.Changes in anthropometric parameters such as Waste/Hip Ratio, Mid upper arm Circumference, Body Fat %, Visceral Fat level % etc. <br/ ><br>3.Changes in general complaints like profuse sweating, irregular thirst, dyspnea and uncontrolled hunger on 0-10 VAS score. <br/ ><br>4.Changes in Lipid profile <br/ ><br>Timepoint: screening , baseline and day 60 <br/ ><br>