Not Yet RecruitingNot Applicable

Clinical Study to Assess the Safety and Efficacy of ACV Moringa Effervescent Tablet Intake on Weight Management in Overweight and Class I Obese Study Participants

66 participantsStarted 2025-07-24

Plain-language summary

A Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Single-Centre, Clinical Study to Evaluate the Safety and Efficacy of Intake of ACV Moringa on the Degree of Weight Change in Overweight and Class I Obese Study Participants

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Age: 18- 65 years (both inclusive) at the time of consent.
✓. Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
✓. Females of childbearing potential must have a self-reported negative urine pregnancy.
✓. Female of childbearing potential must have a reported negative pregnancy during screening and the end of the study
✓. Subject is in good general health as determined by the Investigator on the basis of medical history.
✓. Subjects who are classified as overweight (BMI 25.0-29.9 kg/m²) or as having Class I obesity (BMI 30.0-34.9 kg/m²).
✓. Subjects with a total body fat percentage exceeding 25% for men and 30% for women using Bioimpedance test.
✓. Subject is willing to forgo liposuction procedures or any weight loss therapy 3 months prior to and for the duration of the study.

Exclusion criteria

✕. Subjects BMI is between less than 25 and greater than 35 kg/m2.
✕. Subjects having past or present history or clinically significant findings indicating cardiovascular disease, type 2 diabetes mellitus, hypertension, endocrine, pulmonary, neurological or psychological disorders, hypo or hyperthyroidism and renal disorders.
✕. Subjects with a history of gastrointestinal disorders, including chronic gastritis, gastric discomfort, or any diagnosed gastrointestinal conditions.
✕. Subjects having drug and alcohol abuse.
✕. Smokers and tobacco users.
✕. Subjects having more than 5 kg variation in body weight within 3 months before study entry.
✕. Subjects using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss.
✕. Undergone surgery before 30 days of screening or planning to undergo surgery within the study period.

What they're measuring

Change in body weight using calibrated weighing machine

Timeframe: Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)

Trial details

NCT IDNCT07098624

SponsorNovoBliss Research Pvt Ltd

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-24

Contact for this trial

Maheshvari N Patel

09909013236 maheshvari@novobliss.in

View on ClinicalTrials.gov More Obese or Overweight Healthy Volunteers trials