临床试验/CTRI/2025/06/089660

CTRI/2025/06/089660招募中不适用

Effectiveness Assessment of Madhunashini Vati Extra Power in Type 2 Diabetes Mellitus: Prospective, Open Label, Single Arm, Observational Study

Patanjali Research Foundation3 个研究点分布在 1 个国家目标入组 40 人开始时间: 2025年7月8日最近更新: 2026年1月9日

试验速览

阶段: 不适用
状态: 招募中
发起方: Patanjali Research Foundation
入组人数: 40
试验地点: 3
主要终点: Change in HbA1C

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This open label, single arm, prospective observational study will assess the effectiveness of Madhunashini Vati Extra Power in Type 2 Diabetes Mellitus patients. Patients will be screened on the basis of Inclusion/Exclusion criteria and enrolled after obtaining written Informed consent. The Patients will be followed-up for the next 90 days from the day of enrolment. Primary and secondary outcome will be evaluated by assessing HbA1C and the help of The Revised Version of DQOL (RV-DQOL13)

研究设计

研究类型: Observational

入排标准

年龄范围: 18.00 Year(s) 至 70.00 Year(s)（—）
性别: All

入选标准

•HbA1C between 5.7 to 6.4 The subject is able and willing to provide consent.

排除标准

•Patients with Type 1 Diabetes Mellitus or on Insulin Patients with Gestational diabetes Pregnancy or lactation planning for pregnancy Patients with uncontrolled HTN Any condition the investigator identifies that can confound the participants ability to participate in the study properly.

结局指标

主要结局

Change in HbA1C

时间窗: baseline (Day 1) to Day 90

次要结局

Changes in The Revised Version of DQOL RV DQOL13 Questionnaire(baseline (Day 1) to Day 90)

研究者

发起方

Patanjali Research Foundation

申办方类型

Research institution

责任方

Principal Investigator

主要研究者

Dr Anurag Sharma

Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre

研究点 (3)

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