To Evaluate the Safety of an Ayurvedic Water Based Juice in Healthy Volunteers
- Conditions
- Health Condition 1: E669- Obesity, unspecified
- Registration Number
- CTRI/2024/04/065700
- Lead Sponsor
- Sesa Care Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1)Subjects of either sex between 25 to 45 years of age.
2)Subject with BMI range (26-32).
3)Ability of the subject to understand the risks/benefits of the protocol
4)Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, or double-barrier and have a negative pregnancy test at the Screening Visit. Female subjects of non-childbearing potential must be amenorrhoeic for at least one year or had a hysterectomy and/or bilateral oophorectomy.
5)Willingness to participate in a walking-exercise program (5 days a week, 30 min per day) with the scheduled timing per week during the course of the study.
6)Subject agrees to consume a vegetarian/non-vegetarian diet of approximately 2,000 kcal/day (17% protein, 25% Fat and 58% carbohydrate).
7)Subjects willing to go for DEXA analysis during the study.
8)Subjects willing to get photographed from front and side pose in similar or preferably same set of clothes before and after study. Subject anonymity will be maintained in photographs with an eye strip.
9)Subject should be available for duration of study period (three months).
10)Subjects agree to come to site in fasting state for their weight measurements and other laboratory parameters examination in all the scheduled visits.
11)Subject using other therapies for weight management including physiotherapy/ occupational therapy agrees to discontinue these therapies during this study.
12)Subject agrees not to start any new therapies for weight loss during the study.
13)Subjects agree to maintain the activity dairy
14)Willing to give written informed consent and willing to comply with trial protocol.
1)Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain.
2)Subjects having history of underlying inflammatory arthropathy, septic arthritis, gout, inflammatory joint disease, joint fracture or rheumatoid arthritis.
3)Subjects with hyperuricemia, thyroid disease, abnormal values of liver or kidney functioning or abnormal findings on complete blood count, and hypertension.
4)Subject with hyperuricemia, thyroid disease, abnormal liver or kidney function test, abnormal findings on complete blood count, and hypertension.
5)Subjects having history of asthma, cardiovascular diseases, coagulopathies, diabetes except other than the subject having the pre-diabetes condition with the fasting blood glucose or random blood glucose = 140-199 mg/dl.
6)Subjects having history of high alcohol intake.
7)Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent and increase the risk of adverse events or interfere with study assessments.
8)Subjects, who are pregnant, breast feeding or planning to become pregnant during the study.
9)Immunocompromised subjects or subjects with steroids or immunomodulators.
10)Patients of vulnerable group.
11)Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
12)Subjects participated in any investigational study medication within thirty 30 days prior to screening.
13)Subjects known allergy to compounds of investigational product.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) To measure the total body weight loss by x% <br/ ><br>2) To record the BMI <br/ ><br>3) To evaluate the body fat composition by Dual Energy X-ray Absorptiometry DEXA analysis <br/ ><br>Timepoint: Day 1, Day 30, Day 60 and Day 90 <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1) To assess the waist circumference. <br/ ><br>2) To record the waist to hip ratio <br/ ><br>3) Skin fold thickness measured by skinfold caliper <br/ ><br>4) To evaluate the change in Impact of Weight on Quality-of Life Questionnaire-Lite survey IWQOL-Lite. <br/ ><br>5) Monitor any changes in haematological, liver and kidney function parameters from baseline to the end of <br/ ><br>the study. <br/ ><br>6) To monitor treatment-related adverse events during the study period. <br/ ><br>7) To record photographic evidence.Timepoint: Day 1 and Day 90