A Prospective, Randomized Controlled Comparative Study to Evaluate the Efficacy and Safety of Safuf-i-Dhayabitus in Patients with Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This is a prospective, randomized, open-label, controlled, comparative clinical study designed to evaluate the efficacy and safety of Safuf-i-Dhayabitus, a Unani herbal formulation, in patients with Type 2 Diabetes Mellitus (T2DM). The study will be conducted at SRM Medical College Hospital and Research Centre over a 6-month period.
A total of 100 T2DM patients (aged 30–65 years) will be enrolled and randomized in a 1:1 ratio into two groups:
- Group I (Control): Metformin 500 mg twice daily
- Group II (Test): Safuf-i-Dhayabitus 5 g (1 teaspoon) twice daily
The primary outcomes include reduction in blood glucose levels (FBS, PPBS) and HbA1c from baseline to study end, along with comparative severity assessment between groups. Secondary outcomes focus on safety evaluation through laboratory parameters and monitoring of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs).
Patients will be assessed at baseline, Day 45, Day 90, Day 135, and Day 180, with regular monitoring of glycemic parameters, vitals, systemic examinations, and safety labs. Randomization will be computer-generated, and the study will adhere to ICH-GCP guidelines and the Declaration of Helsinki.
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
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients within the age range of 30 and 65 years of age diagnosed with T2DM for at least 6 months.
- •Participants with fasting plasma glucose greater than or equal to 126 mg/dL or random plasma glucose greater than 200 mg/dL.
- •Participants with an HbA1c value of 6.5–8 percent.
- •Willingness to provide written informed consent to participate in the study.
排除标准
- •Type 1 Diabetes Mellitus HbA1c greater than eight percent.
- •Severe renal, hepatic, cardiac, gastrointestinal, neurological, hematological, or respiratory disorders, in the view of the investigator.
- •Patients with psychiatric disorder.
- •History of smoking more than ten cigarettes per day or alcohol intake greater than twenty grams per day.
- •History or evidence suggestive of complications of diabetes such as retinopathy, nephropathy, or ischemic heart disease with any cardiac event in the last six months.
- •Body mass index greater than thirty five kilograms per square meter or less than twenty kilograms per square meter.
- •Patients who are likely to undergo surgery during the study period.
- •Patients who have participated in any investigational study in the last twelve weeks.
- •Known hypersensitivity to the study drugs.
- •Patients with severe infection, in the view of the investigator.
- •History of intake of any Ayurvedic, herbal, homeopathic, or dietary supplements in the last two months.
- •Pregnant or nursing mothers and women of childbearing age refusing to use contraceptives.
研究者
Dr RC Satish Kumar
SRM Institute of Science and Technology