CTRI/2010/091/000424已完成未知
A multicentric prospective randomized, single blind study to evaluate the efficacy and safety of Eugenia jambolana and Momordica charantia following multiple dose administration in subjects diagnosed with NIDDM
Self funded0 个研究点目标入组 30 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
- 30
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 who are willing to give signed informed consent.
- •2. Male or female subjects at least 18 years of age and no more than 70 years of age
- •3. Women of childbearing potential, or men of reproductive potential, must be using adequate (in the investigator's opinion) birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilisation) during the study. Female subjects of childbearing potential must test negative for pregnancy prior to enrolling in the study. Post menopausal (cessation of menses for more than 2 years) women are eligible for this study.
- •4. Diagnosis of Diabetes as per WHO diagnosis criteria 1999 ((For newly diagnosed patients: FBSL >120 mg% and after 2 hours of consuming 75 grams of glucose: >180 mg %).
- •5. Patient having fasting plasma glucose level above 110 mg/dl and/or postprandial plasma glucose level in between 140 to 300
排除标准
- •Subjects who meet any of the following criteria will be excluded from this study:
- •1. Body weight >98 kg.
- •2. Pregnant, nursing, or planning a pregnancy (both men and women) within 9 months of enrolment.
- •3. Screening laboratory tests:
- •a) haemoglobin ≤ 8.0 gm/dl
- •b)white blood cells ≤ 3.0 x103 cells/µl
- •c)neutrophils ≤ 1.5 x 103 cells/µl
- •d)platelets ≤100 x 103 cells/µl
- •e)serum transaminase level (AST and ALT) ≥ 2 times upper limit of normal (ULN)
- •f)serum creatinine ≥ 0.15 mmol/l
- •4. Subjects with a history of any clinically significant adverse reaction to study medication, including serious allergic reactions.
- •5. Subjects with a history of, presence of, or at high risk of serious infection including:
- •i) history of active TB, or positive Mantoux test or QuantiFERON Gold test or chest x-ray suggestive of active or healed TB or positive contact history with a subject with active TB within the past 3 months. If patients have a positive Mantoux test but a negative QuantiFERON Gold test, they may be enrolled.
- •ii) a serious infection during the 3 months prior study entry (hospitalised or received IV antibiotics for an infection).
- •iii) chronic or recurrent infectious disease.
- •iv) systemic fungal infections
- •v) opportunistic infection within 3 months prior to screening (refer to 1993 CDC Classification System for HIV Infection).
- •vi) subjects known, or suspected, to be infected with HIV, hepatitis B, or hepatitis C.
- •6. Subjects with evidence of severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral disease.
- •7. Concurrent CHF, including medically controlled, asymptomatic CHF or ECG findings suggestive of CHF.
- •8. Subjects receiving cytotoxic drugs including cyclophosphamide, cyclosporine, or alkylating agents within 6 months prior to first study dose.
- •9. Known history or evidence of malignancy, lymphoproliferative or neoplastic disease
- •10. with the exception of successfully treated basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
- •11. Subjects who have undergone organ transplant (with exception of a corneal transplant more than 3 months prior to screening).
- •12. Subjects previously enrolled in this study, currently participating in another investigational study or treated with any investigational drug within the previous 3 months or within 5 half-lives, whichever is greater, prior to first study dose.
- •13. Any other clinically significant disease or disorder or factors such as substance abuse which in the opinion of the investigator make the subject ineligible for participation in this study.
- •14. Patients with concomitant severe illness necessitating other medications, patients with severe hypertension, history of severe unstable angina, myocardial infarction, CVAs, renal failure, and those patients
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