Health Condition 1: Z683- Body mass index (BMI) 30-39, adult
Conditions
Interventions
Intervention1: Each Herbal Blend having (Ginger 0.65 g,Butterfly Pea 0.60g, Lemongrass 0.50g, Dandelion 0.45g and Spearmint 0.30g per serving): Thrice daily after
meals for(60+2) days
Control Interve
Sponsors
Redplum Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and females aged 22 tov35 years (both inclusive) 2.Participants with Class I (BMI between 29.1 and 35.0 Kg/m2) obesity, who have experienced significant weight gain (at least 10 kg) over the past three years. 3. Female participants are either not of childbearing potential, or females of childbearing potential agree to use a medically approved method of birth control and have a negative urine pregnancy test result. 4. Those without comorbidities who have been on stable medication. 5. Participants should be ready to consume the product daily, written informed consent to participate in the study, maintain a consistent diet and activity level, and submit regular reports (ex: weight, activity, sleep) as required by the study. 6.Height should not be more than 5.6. 7. Waist should not be less than 36 inches. 8. A signed declaration from each participant confirming that they do not have any known allergy (including pollen allergy) issues prior to signing the informed consent. 9. Participants must be willing to maintain a minimum daily physical activity level of 8,000 10,000 steps and accurately record daily step counts in the participant diary throughout the study duration. 10. Indemnity / Liability Disclaimer: A clause or separate document ensuring that participants cannot make future claims for any health issues due to the clinical trial procedure.
Exclusion criteria
Exclusion criteria: 1. Underweight or severely obese individuals may have metabolic or health conditions that could skew results or require medical supervision. 2. Women who are Pregnant or lactating 3. Participants with BMI values less than 29.0 and greater than 35.1 kg/m2. 4. Participants with hypersensitivity to the investigational product. 5. Participants with diagnoses of diabetes, thyroid conditions, or other metabolic diseases are excluded to prevent interference from disease-related factors or medications. 6. Participants who have undergone surgery in the last 6 months, including but not limited to angioplasty, abdominal surgeries (including weight loss surgery), or partial/complete resection of stomach or bowel. 7. Participants with the presence or history of psychiatric illnesses, including eating disorders. 8. Participants using drugs or supplements that impact weight, appetite, metabolism, or digestion (eg, Steroids, fat burners) or using phytoherbal supplements, dietary, nutraceuticals, allopathic, or Ayurvedic supplements for weight loss. 9. Participants with a family history of obesity. 10. Participants in structured diets, exercise regimens, or medical weight loss treatments. 11. Participants using any weight loss supplements like high doses of vitamin D or GLP one analogs, fiber supplements known to affect hunger/satiety/appetite/gut microbiome or currently using blood thinners. 12. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study. 13. Participants with a history of substance abuse or heavy use of alcohol and drugs or tobacco use. 14. Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound the study Outcomes. 15. Participants who are unlikely to follow the daily routine (tea consumption, tracking weight/ activity/ sleep, etc) or provide data regularly.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in body weight (Kg) from baseline to end of the studyTimepoint: Day 1, Day 30, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in waist circumference from baseline to end of the study. Percentage of participants adhering to the prescribed tea regimen. Number and type of adverse events or side effects reported by participants throughout the study. Percentage of participants adhering to the prescribed tea regimen. Changes in Body Mass Index (BMI) from baseline to end of the study. Change in WHOQOL BREF questionnaire scores and basal metabolic rate (BMR) from baseline to end of study. Number and type of adverse events or side effects reported by participants throughout the study. Percentage of participants adhering to the prescribed tea regimen Timepoint: Day 1, Day 30, Day 60 | — |
Countries
India
Contacts
Public ContactDivya Chandradhar
BioAgile therapeutics Private Limited
Outcome results
None listed