CTRI/2023/04/051857已完成Unknown
A Prospective, Open Label Single-Arm Clinical Study to Assess the Efficacy and Safety of D-PRIO®, a herbal formulation on patients with Type 2 Diabetes Mellitus.
Priority Herbals Pvt Ltd0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- •1. Adult males and females of ages = 18 years and =60 years
- •2. Patients who can and willing to provide written Informed Consent.
- •3. Patients suffering from Type-2 Diabetes of less than 10 years duration
- •4. Patients with HbA1c >6.5% and <9%
- •5. Patients with fasting plasma glucose >126 mg/dL and <180 mg/dL
- •6. Patients with Body mass index: 25-34.9 kg/m2
- •7. Participant who agree to take Investigational product (IP) till Day 90.
- •8. Patients willing to be on a restricted diet (no sugary foods or drinks, no sugar in tea or coffee, no honey, no rice, no white bread, no potatoes, no fried meat/fish, no banana and mangoes) during the duration of the study
- •9. Patients having capability of complete compliance and completion of follow-up
- •10. Participant / participant’s legally acceptable representative understands and can comply with clinical trial protocol requirements.
排除标准
- •1.Patients on current prescription of any medicine for Diabetes or any drug that impacts glucose level
- •2.Patients with diabetes other than Type 2 diabetes mellitus
- •3.Patients having a history or presence of clinically relevant cardiovascular renal thyroid metabolic hematological neurological psychiatric systemic or infectious disease or malignant tumor
- •4.Patients suffering from any Bleeding disorders or Glucose 6-Phosphate Dehydrogenase deficiency
- •5.Patients with severe mental disorder
- •6.Patients with recent hospitalization for major illness or elective surgery within 1 year of the start date of study
- •7.Female patients with pregnancy or lactation or intention to become pregnant and not using appropriate contraceptive methods
- •8.Patients with terminal illness
- •9.Patients with history of alcoholism or substance abuse
- •10.Patients who are not willing to take investigational product
- •11.Patients with known history of sensitivity or allergy to any herbs or herbal products
- •12.Patients on dietary supplements or multivitamins or disease specific oral nutrition supplements
- •13.Patients with uncontrolled or unstable comorbidities
- •14.Patients with respiratory conditions or diagnostic history with chronic lung disease or active malignancy or chronic kidney disease or chronic liver disease
- •15.Patients taking part in any other studies including macro or micro or any other forms of dietary supplements or multivitamins or disease specific oral nutrition supplements
- •16.Any other condition which the principal investigator thinks may jeopardize the safety of patients with uncontrolled or unstable comorbidities
- •17.Patients who had participated in other clinical trials during previous 3 months
研究者
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