Evaluation of Triphala as an Add-on Intervention for Sustained Anti-obesity Effect in Central Obesity: A Randomized Placebo-Controlled Clinical Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 880
- 试验地点
- 3
- 主要终点
- Change in waist circumference
研究概览
简要总结
This is randomized; double-blind, placebo-controlled clinical trial evaluates Triphala as an add-on intervention to standard care (calorie restriction & physical activity advice as per ESI Guidelines) for Sustained Anti-obesity Effect in Central/Abdominal Obesity Adults
Participants having abdominal/central obesity (waist circumference greater than or equal to 90 cm for men and greater than or equal to 80cm for women), willing to participate and provide written informed consent, will be enrolled in the study.
A total of 880 participants will be randomized (1:1) into two groups: one receiving Triphala (500 mg, 2 tablets twice daily on an empty stomach for 3 months) and the other receiving a placebo, both along with standard care (calorie restriction & physical activity advice) and a subset of 220 participants (110 per group) will undergo DEXA Scan to determine the percentage of Fat change/loss.
Participants will undergo assessments: Change in waist circumference, Sagittal Abdominal Diameter, waist–hip ratio, body weight/BMI, & Blood Pressure (measured at Screening,0, 3, 6, 9, 12, & 15 months), Fat Mass & LBM (measured at 0,3, & 15 months by DEXA for a subset of 220 participants), and HbA1c, Lipid profile, Resting Metabolic Rate (measured at 0,3, & 15 months), Safety parameters, including liver and renal function tests will be performed (measured at 0, and 3 month), complete blood count (measured at 0, 3, 15 months), and adverse event monitoring, will be carried out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals with abdominal/central obesity (waist circumference greater than or equal to 90 cm for men and greater than or equal to 80cm for women)
- •Individuals between 18-60 years of age.
- •Willing to participate voluntarily & gives written consent to participate in the study.
排除标准
- •Individuals with hypothyroidism or uncontrolled thyroid disease
- •Patients who were treated with sliming drugs.
- •Pregnant and lactating women.
- •Individuals who have undergone surgery recently.
- •Patients with coronary heart disease.
- •Uncontrolled diabetes mellitus (glycosylated hemoglobin greater than 8.0 percent).
- •Individuals with a history of chronic kidney and liver disease.
- •History or evidence of any other condition or disease that, in the opinion of the investigator would interfere with the study evaluation, procedures, or completion
- •Patients receiving corticosteroid or immunosuppressive medications.
- •History of use one month before screening or currently using Allopathic or Ayurvedic medicines that may cause significant weight gain.
- •Active substance abuse like alcohol or drug abuse in any form or history of alcohol/drug abuse or dependence within 6 months prior to study enrolment.
- •Current participation (past one month) in an organized weight reduction program.
- •Individuals having any other medical conditions investigator(s) feel unfit to recruit.
结局指标
主要结局
Change in waist circumference
时间窗: Waist circumference will be measured at screening,0, 3, 6, 9, 12, and 15 months.
次要结局
- Changes in blood glucose (HbA1c)(Screening/Baseline (0), 3, & 15 months)
- Changes in Fat mass & Lean body mass (LBM)(measured by DEXA for a subset of 220 participants)(0, 3, & 15 months)
- Lipid profile(0, 3, & 15 months)
- Changes in Sagittal Abdominal Diameter (SAD), waist–hip ratio, body weight/BMI, & BP(Screening,0, 3, 6, 9, 12, & 15 months)
- Changes in Resting Metabolic Rate (RMR by indirect calorimetry)(0,3, & 15 months)
- Safety Parameters: Complete Blood Count, Liver Function Test, Renal Function Test(Complete Blood Count (measured at 0, 3, 15 months) & Liver Function Test, Renal Function Test (measured at 0, 3 months))
研究者
Dr Banappa S Unger
ICMR National Institute of Traditional Medicine