CTRI/2022/05/042752招募中未知
Efficacy and safety of Twin Precision treatment in patients with hypertension- a multicentric, open-label, randomised controlled trial - TPT-4
TWINS DIGITAL SERVICES INDIA PRIVATE LIMITED0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients with diagnosis of primary hypertension (either adequately controlled or inadequately controlled with blood pressure = 180/110 mm Hg); both treatment naive & on treatment (includes monotherapy or multiple drugs)
- •Age 18 years and above
- •Of either gender
- •Willing to follow study specific activities and able to handle smartphone
排除标准
- •Key exclusion criteria
- •Uncontrolled hypertension ( > 180/110 mm of Hg)
- •H/o hypertensive emergency requiring admission / Resistant Hypertension
- •Diabetes mellitus
- •Major Gastrointestinal diseases such as Inflammatory bowel disease, irritable bowel syndrome that can interfere with dietary intervention
- •Use of contraindicated drugs such as antacids of magnesium, calcium, steroids, lithium, anti-migraine drugs, phenytoin, anti-psychotics (SSRI, SNRI, and TCA), immuno-modulators, any narcotic drugs, and oral contraceptives.
- •Having received any investigational drug or device within 30 days prior to entry into the study
- •Poor compliance during screening or run in.
- •Autoimmune disorders and Connective tissue disorders
- •Total bilirubin of > 2 mg/dL or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 5 times the upper limit of normal range
- •Pregnant or planning to conceive in the next 3 years or breastfeeding
- •Psychiatric illness such as psychosis, manic depressive illness, alcohol or drug dependence .
- •Consumption of >14 alcoholic beverages per week (for women) and > 21 for men
- •Any other condition or illness which the investigator feels would make the patient ineligible or make the patient difficult to participate in the study
- •Any major cardiovascular event in the last 6 months (such as MI, stroke, TIA)
- •Hypertensive Retinopathy (grade 3 and above)
- •Weight loss more than 5% in 3 months
- •Arm circumference too large or small to allow accurate BP measurement with available devices
- •Special dietary requirements,or medications that would affect blood pressure (other than antihypertensive drugs) or nutrient metabolism
- •Unwilling or inability to modify current diet
- •Hypercalcemia ( > 10.5 mg/dl) and Hyperkalemia.( >5.5 mmol/l)
- •Known Malignant cases < 5 years
- •Anemia (Hb < 8 gm)
- •Heart failure with EF < 40%
研究者
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