An Open Label Study to Evaluate the Efficacy and Safety of an Ayurvedic Water Based Juice Formulation on Weight Management in Healthy Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1) To measure the total body weight loss by x%
研究概览
简要总结
Obesity represents a medical state of excess body fat accumulation as a consequence of energy imbalance between calories consumed and calories disbursed. Obesity is associated with a host of potential comorbidities such as type II diabetes mellitus, hypertension, coronary heart disease, osteoarthritis, stroke, depression, non-alcoholic fatty liver disease, infertility (women), erectile dysfunction (men), risk of stillbirth, gallbladder disease, obstructive sleep apnoea, gastroesophageal reflux disease, some cancers (endometrial, breast, and colon), 1 etc. Weight management refers to the process of making long-time lifestyle changes to maintain a healthy body weight based on age, height, and sex. Weight management includes eating a healthy, balanced diet, and increasing levels of physical activity.3 Ayurveda, one among the popular complementary alternative medicine has a more extensive and holistic treatment of chronic illness such as obesity.1 Ayurvedic ActivSlim juice from Sesa wellness helps in the weight management by boosting metabolism, burning excessive fat, supports healthy lipid levels, and building immunity. The Ayurvedic ActivSlim juice has been made with a unique blend of 14 Ayurvedic herbs. This study aims to evaluate the efficacy and safety of an Ayurvedic water based slim juice formulation (Ayurvedic ActivSlim juice) on weight management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either sex between 25 to 45 years of age.
- •Subject with BMI range (26-32).
- •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.
- •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.
- •Subject agrees to consume a vegetarian/non-vegetarian diet of approximately 2,000 kcal/day (17% protein, 25% Fat and 58% carbohydrate).
- •Subjects willing to go for DEXA analysis during the study.
- •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.
- •Subject should be available for duration of study period (three months).
- •Subject using other therapies for weight management including physiotherapy/ occupational therapy agrees to discontinue these therapies during this study.
- •Subject agrees not to start any new therapies for weight loss during the study.
- •Subjects agree to maintain the activity dairy 14) Willing to give written informed consent and willing to comply with trial protocol.
排除标准
- •Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain.
- •Subjects having history of underlying inflammatory arthropathy, septic arthritis, gout, inflammatory joint disease, joint fracture or rheumatoid arthritis.
- •Subjects with hyperuricemia, thyroid disease, abnormal values of liver or kidney functioning or abnormal findings on complete blood count, and hypertension.
- •Subject with hyperuricemia, thyroid disease, abnormal liver or kidney function test, abnormal findings on complete blood count, and hypertension.
- •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.
- •Subjects having history of high alcohol intake.
- •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.
- •Subjects, who are pregnant, breast feeding or planning to become pregnant during the study.
- •Immunocompromised subjects or subjects with steroids or immunomodulators.
- •Patients of vulnerable group.
- •Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
- •Subjects participated in any investigational study medication within thirty 30 days prior to screening.
- •Subjects known allergy to compounds of investigational product.
结局指标
主要结局
1) To measure the total body weight loss by x%
时间窗: Day 1, Day 30, Day 60 and Day 90
2) To record the BMI
时间窗: Day 1, Day 30, Day 60 and Day 90
3) To evaluate the body fat composition by Dual Energy X-ray Absorptiometry DEXA analysis
时间窗: Day 1, Day 30, Day 60 and Day 90
次要结局
- 1) To assess the waist circumference.(2) To record the waist to hip ratio)
研究者
Dr Rachana K L
TrialGuna Private Limited