CTRI/2017/05/008444已完成未知
Pilot Randomized, Double Blind, Placebo Controlled, Multi Centric, 4 arm Clinical Trial to Assess the Efficacy and Safety of Costus Extract in Patients with Type 2 Diabetes Mellitus
Clinfound Clinical Research Services PvtLtd0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
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.Male or Female Patients aged 30-65 years
- •2.Patients newly diagnosed with diabetes with HbA1C >6.0% to 7.5%, FPG >126 mg/dL to
- •170 mg/dL, 2-hr OGTT = 200 mg/dL.
- •3. Patients not taking any allopathic medication or insulin (including herbal product) for
- •management of diabetes since diagnosis
- •4. Able to do moderate intensity physical exercise and life style modification
- •5. Patients ready to give written informed consent and willing to comply the study protocol
- •Inclusion Criteria –Group B
- •1. Male or Female Patients aged 30-65 years
- •2. Diagnosed Diabetic patients with HbA1C >6.5% to 11.0%, FPG >126 mg/dL to 200
- •mg/dL, 2-hr OGTT = 200 mg/dL.
- •3. Patients on Oral Hypoglycemic Agent Metformin.
- •4. Patients not taking any herbal product for management of diabetes since last 4 weeks.
- •5. Patients ready to give written informed consent and willing to comply the study protocol
排除标准
- •Exclusion Criteria – Group A
- •1. Oral hypoglycemic agents or other anti-diabetic drugs
- •2. Antiplatelet, ACE Inhibitors, ARBs, Lipid lowering drugs
- •3. NASIDS (prolonged use for more than 10 days)
- •4. Any herbal supplement/ drug
- •5. Blood pressure: BP = 160/100 mmHg.
- •6. Any clinical history of cardiovascular disease,Liver, hormonal disorder or treatment.
- •7. History of peptic ulcer disease and/or GI bleeding/perforation
- •8. History of cancer
- •9. History or presence of proliferative retinopathy, severe non-proliferative retinopathy, macular
- •edema or presence of untreated diabetic eye disease
- •10. History of treated peripheral or autonomic neuropathy
- •11. Pregnant or lactating females or absence of effective contraceptive methods for females of
- •childbearing potential.
- •12. Patient with impaired kidney function (serum creatinine more than upper limit of normal) or liver
- •function (serum transaminase more than 3 times upper limit of normal)
- •13. Presence of any severe medical or psychological condition or chronic condition/ inflammation/
- •infection that in the opinion of the investigator would compromise the patient’s safety or
- •successful participation in the study.
- •14. Participation in any other clinical study within 30 days of screening.
- •15. Patients receiving any of the drugs within 3 months of screening or at the time of screening:
- •16. Systemic long acting corticosteroids (prolonged use for more than 10 days) or
- •immunosuppressant
- •17. Conditions/criteria likely to interfere with participation and acceptance of randomized
- •assignment, including the following: inability/unwillingness to give informed consent, major
- •psychiatric or cognitive problems (schizophrenia, dementia), self-reported active illegal substance
- •or alcohol abuse, and clinical judgment.
- •Exclusion Criteria – Group B
- •1. Patients on any other diabetic drugs other than MetforminAntiplatelet, ACE Inhibitors, ARBs,
- •Lipid lowering drugs
- •2. NASIDS (prolonged use for more than 10 days)
- •3. Any herbal supplement/ drug
- •4. Blood pressure: BP = 160/100 mmHg.
- •5. Any clinical history of cardiovascular disease,hormonal disorder or treatment.
- •6. History of peptic ulcer disease and/or GI bleeding/perforation
- •7. History of cancer
- •8. History or presence of proliferative retinopathy, severe non-proliferative retinopathy, macular
- •edema or presence of untreated diabetic eye disease
- •9. History of treated peripheral or autonomic neuropathy
- •10. Pregnant or lactating females or absence of effective contraceptive methods for females of
- •childbearing potential.
- •11. Patient with impaired kidney function (serum creatinine more than upper limit of normal) or liver
- •function (serum transaminase more than 3 times upper limit of normal)
- •12. Presence of any severe medical or psychological condition or chronic
- •condition/inflammation/infection that in the opinion of the investigator would compromise the
- •patient’s safety or successful participation in the study.
- •13. Participation in any other clinical study within 30 days of screening.
- •14. Patients receiving any of the drugs within 3 months of screening or at the time of screening:
- •15. Systemic long acting corticosteroids (prolonged use for more th
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