CTRI/2021/08/036060尚未招募2 期
A Randomized, Open label, Prospective, Three Arm, Parallel, Multicenter study to Evaluate Efficacy and Safety of Metformin with / without Concomitant Administration of Thymoquinone in Patients with Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
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. Patients of either gender between 18 and 65 years (both inclusive) of age.
- •2. Patients with type 2 diabetes mellitus.
- •3. Body mass index (BMI) between 18 kg/m2 to 30 kg/m2 (both inclusive)
- •4. Patients who are receiving stable dose of metformin 1000 mg/day for last 3 months
- •5. Patients with HbA1c greater than or equal to 7.0 percentage and less than or equal to 7.5 percentage.
- •6. Provides written informed consent in accordance with applicable regulatory requirements.
- •7. Women of child bearing potential must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives (any hormonal method in conjunction with a secondary method), intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile (at least 6 months prior to study drug administration) sexual partner for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Male patients must agree to use a male condom throughout the study.
- •8. Serum pregnancy test at screening and urine pregnancy test at check-in must be negative for women of child bearing potential (WOCBP).
排除标准
- •1. Patients taking other oral/injectable antidiabetic agents (e.g. sulfonylurea, insulin) within last 3 months before screening.
- •2. Patients on drugs (e.g. steroids, hydroxychloroquine etc.) or herbal products or food (including black cumin seeds) affecting blood glucose within last 3 months prior to screening (exception of ongoing statin therapy / beta blockers in recommended doses that is stable for last 3 months).
- •3. Patients with drug abuse including narcotics, opioids or any other addictive substances.
- •4. Any major organ system disease, chronic cardiac illness (e.g. ischaemic heart disease, heart failure, cardiac arrythmias), chronic liver disease (e.g. hepatic failure, active hepatitis, liver cirrhosis), renal complications and any other chronic debilitating illness.
- •5. Women of childbearing potential not agreeing to use an effective form of contraception.
- •6. Known hypersensitivity to Thymoquinone or metformin or any of its ingredients.
- •7. Creatinine clearance less than or equal to 60 ml/min or known case of renal impairment.
- •8. Clinically significant laboratory abnormalities at the time of screening.
- •9. Patients participated in any type of clinical study within the last 30 days of the screening date.
- •10. Any other condition which in the opinion of the investigator could jeopardize the safety of the subject or the validity of the study results. Unsuitability for enrollment otherwise as decided by investigator.
- •11. Patients for whom oral administration of drug is not possible.
- •12. Treatment with anti-obesity drugs within last 3 months prior to screening or patients who have undergone bariatric surgery.
研究者
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