Effectiveness of pomegranate peel as an adjunct to antihypertensive and hypoglycemic drugs treatment on Blood pressure, Hb1Ac, lipid profile and oxidative stress among diagnosed Diabetes Mellitus II and Hypertensive patients at Health and wellness center in Umred Block in Nagpur District: a cluster randomized trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 210
- 试验地点
- 1
研究概览
简要总结
This cluster-randomised controlled trial aims to evaluate the effectiveness of pomegranate peel tablets as an adjunct to standard antihypertensive and hypoglycaemic therapy among adults diagnosed with Type II diabetes mellitus and grade-1 hypertension attending Health and Wellness Centres in Umred Block, Nagpur District. Eligible participants will continue to receive routine conventional treatment and will be allocated to either an intervention group receiving pomegranate peel tablets or a control group receiving standard care alone. The primary outcomes include changes in blood pressure, HbA1c, lipid profile, and oxidative stress parameters measured at baseline and at predefined follow-up intervals over an 18-month intervention period. The study seeks to generate evidence on the potential role of a pomegranate peel–based adjunct intervention in improving metabolic and cardiovascular outcomes in a community-based public health setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are diagnosed with diabetes mellitus and hypertension, both on conventional treatment (Metformin or Amlodipine) for at least 6 months of duration
- •Willing and able to give informed consent for participation in the trial.
- •Patients who are willing to adhere to conventional care for the duration of the trial
- •Individuals of any gender aged 18 years or above.
- •Patients on medication for Diabetes with good and fair control of Diabetes mellitus (HbA1c 6.5-8)
- •Patients with grade 1 Hypertension, Systolic hypertension 140 -159 mmHg and diastolic hypertension 90- 99 mmHg.
排除标准
- •Pregnancy and lactation
- •History of allergy or drug hypersensitivity to any of the Ayurveda interventions
- •Having participated in other clinical trials within 12 weeks before the screening or currently enrolled in another trial.
- •Known kidney disease
- •Patients with blood pressure greater than 159 mmHg Systolic or greater than 99 mmHg diastolic
- •Patients with HbA1c greater than 8.0.
研究者
Dr Ranjan Solanki
AIIMS Nagpur