Clinical Trial on Kapiva Weight Wise Foods Get Slim Plus Juice
- Conditions
- Health Condition 1: E669- Obesity, unspecified
- Registration Number
- CTRI/2023/03/050908
- Lead Sponsor
- Adret Retail Pvt Ltd (Kapiva Ayurveda)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Male/female patients aged between 20-45 years (both inclusive) with BMI between 25-35 kg/m2;2.Patient with or without hypothyroidism. Patients with hypothyroidism on medication should be stable and have a normal TSH level;3.Patients with or without comorbidities, if comorbidity exists should be on stable prescription and with following criteria- Hypertension (Less than or equal to 140/90 mmHg on prescription), Type 2 DM (HbA1C less than or equal to 7.5 on prescription);4.Willing to provide consent;
5.Willing for follow up.
1.Patients with any acute illness requiring immediate medical care.
2.Patients with PCOS, PCOD, infertility disorder or any other hormonal disorder.
3.Patients with Type I DM/Complicated cardiovascular diseases / HbA1C greater than or equal to 7.5/ history of TIA, cerebrovascular accident, stroke or any revascularization.
4.Known patients of hepatic failure/renal impairment.
5.Pregnant, breastfeeding or planning to become pregnant during the study.
6.Any other condition which proves the patient 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 and body mass index (BMI) on screening, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7. <br/ ><br>2.Changes in anthropometric parameters such as waist/hip ratio, mid upper arm circumference, body fat %, visceral fat level % on screening, visit 3, visit 5 and visit 7. <br/ ><br>3.Changes in the Quality of life of patients by IWQOL-Lite score (The Impact of Weight on Quality-of-Life Questionnaire) in social and emotional aspect on screening, visit 3, visit 5, visit 7. <br/ ><br>4.Changes in the number of high to moderate energy events from energy audit diary on screening, visit 3, visit 5, visit 7.Timepoint: Screening visit ,Visit 2,Visit 3,Visit 4,Visit 5,Visit 6,Visit 7
- Secondary Outcome Measures
Name Time Method 1.Changes in digestive behavior (Bloating, Heartburn, Flatulence, Constipation, Post Prandial Fullness, etc.) in patients on screening, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7. <br/ ><br>2.Changes in lipid profile on screening, and visit 7. <br/ ><br>3.Changes in general complaints like profuse sweating, irregular thirst, dyspnea, and craving on 0-10 VAS score screening, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7.Timepoint: Screening visit ,Visit 2,Visit 3,Visit 4,Visit 5,Visit 6,Visit 7