A Controlled Clinical Study to Evaluate the Safety and Efficacy of Qurs Tabasheer in the Management of Type 2 Diabetes Mellitus.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
研究概览
简要总结
Patients diagnosed with diabetes mellitus attending the Outpatient Department of Majeedia Unani Hospital who are willing to participate will be screened according to predefined inclusion and exclusion criteria. Written informed consent will be obtained from each eligible participant prior to enrollment. After enrollment, patients will be randomized into two groups. Group A will receive the polyherbal formulation Qurs Tabasheer at a dose of 4.85 g daily, administered as three tablets twice daily, while Group B will receive Metformin 500 mg twice daily. Baseline demographic details, clinical examination findings, and relevant investigations will be recorded in the Case Report Form. Participants will be followed weekly for assessment of clinical signs and symptoms, with fasting blood sugar measured at each visit and documented in the Case Report Form. At the end of the 45 day treatment period, all baseline investigations including fasting blood sugar, postprandial blood sugar, complete blood count, liver function tests, kidney function tests, serum insulin, and lipid profile will be repeated and recorded in the Case Report Form. The primary outcome will be the change in fasting blood sugar from baseline to day 45, while secondary outcomes will include changes in postprandial blood sugar, serum insulin, lipid profile, and clinical symptom scores.
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
- •Fasting blood sugar (FBS) must be greater than or equal to 126 mg/dl but less than or equal to 200 mg/dl.
- •OR 2) Postprandial blood sugar (PPBS) must be greater than or equal to 200 mg/dl but less than or equal to 300 mg/dl.
- •OR 3) Glycated hemoglobin (HbA1c) must be greater than or equal to 6.5 % but less than or equal to 8 %.
- •Patients who were able and willing to follow anti-diabetic therapy under stable lifestyle and diabetic diet.
排除标准
- •History of treatment with any medication for glycaemic control (except metformin) within 3 months.
- •History of treatment with systemic corticosteroids within 3 months.
- •Pregnant or lactating women.
- •History of any severe systemic disease.
- •Patients with uncontrolled hypertension.
- •History of drug or Alcohol abuse.
研究者
Dr Khan Asgar Jamal Abdul Mannan
Jamia Hamdard
