Clinical Efficacy Of Chilbeenj (Strychnos Potatorum) In The Management Of Dhayabitus Sukkari (Type 2 Diabetes Mellitus): A Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Reduction in FBS and 2-hr PPBS
研究概览
简要总结
NEED OF THE STUDY
Type 2 Diabetes Mellitus (T2DM) is rising rapidly in India(3), with increasing prevalence even in rural areas and among younger populations. Despite the availability of many treatments, long-term use often leads to adverse effects, high costs, and limited efficacy in managing glycemic levels. Given the classical Unani perspective on diabetes and the emerging evidence of Strychnos potatorum (Chilbeenj/Nirmali) exhibiting hypoglycemic and antioxidant properties as per preclinical studies, there is a compelling need to scientifically validate its efficacy. This study aims to bridge traditional Unani knowledge with modern pharmacological evaluation to explore a safer, effective, and alternative approach for managing T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •Age 30 years to 60 years
- •Both Genders
- •Recently Diagnosed Cases of Type 2 DM up to 3 years
- •Fasting Blood Sugar (FBS) Less than or equal to 126mg/dl Up to 200mg/dl 5.2hr Plasma Glucose (2PG) less than or equal to 200 mg/dl Up to 300 mg /dl 6.HbA1C more than 6.5 up to 9
- •Participants willing to participate in this study
- •Patients taking less than or equal to 2 hypoglycaemic drugs will be included in the study.
排除标准
- •History of allergy or intolerance to any drug,
- •Type 1 diabetes,
- •Fasting blood sugar (FBS) more than 200mg/dl,
- •2-hr Plasma Glucose (2PG) more than 300mg/dl, 5.HbA1C more than 10,
- •Diabetic patients with serious acute and chronic complications, such as diabetic ketoacidosis, Known cases of type 2 diabetes mellitus requiring insulin treatment
- •Pregnant or lactating women,
- •Patients who are on medication more than 3 hypoglycemic drugs,
- •History of Patients with known systemic illnesses such as chronic kidney disease, liver disorders, cardiovascular disease, or autoimmune conditions will be excluded.
- •Alcoholics, smokers, and drug addicts.
结局指标
主要结局
Reduction in FBS and 2-hr PPBS
时间窗: 4 weeks : 0 (baseline), 2 weeks, 4 weeks
次要结局
- 1. changes in oxidative stress markers PC – Protein Carbonyl(27), FRAP – Ferric Reducing Antioxidant Power(28).(2. Improvement in ADQOL (Asian Diabetes Quality of Life))
研究者
Dr DUA HARMAIN A S
Government Unani Medical College