CTRI/2020/09/028006尚未招募2 期
Efficacy of Aardra and Shushka Guduchi [Tinospora cordifolia (Willd) Miers] in the management of Madhumeha (Type-II DM): A Comparative open label Randomized controlled clinical trial
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. Recently diagnosed (less than 1 year of diabetic history) cases of Type-2 DM and not taking any antidiabetic drug/Insulin since 2 months
- •2. Including both Pre-diabetes and diabetes cases
- •Fasting Blood Sugar (FBS) ranges between 100 to 125 mg/dl in pre-diabetes and greater than 126 mg/dl to less than equal to 200 mg/dl in diabetes cases.
- •Post Prandial Blood Sugar (PPBS) ranges between
- •140 to 199 mg/dl in Pre-diabetes and greater than 200 mg/dl to less than equal to 350 mg/dl in diabetes cases.
- •HbA1c ranges between 5.7 % to 6.4 % in Pre-diabetes and greater than equal to 6.5 % to less than equal to 8 % in diabetes cases.
- •3. Presence of urine sugar
- •4. Frequency of urination 7 to 10 times per 24 hours and quantity and quantity greater than equal to 2500 ml
- •5. Accidentally diagnosed cases of Type-2 DM who visit the hospital for other complaints
排除标准
- •1. Cardiovascular disorder with Type-2 DM
- •2. Malignant and accelerated Hypertensive
- •3. Pregnant woman and planning to be pregnant within 6 months
- •4. Lactating mother
- •5. Secondary Diabetes Mellitus
- •6. Patients undergoing regular treatment for diabetes or any other severe illness
- •7. CNS Disorder e.g. Encephalopathy
- •8. Subjects already suffering from the complications of Diabetes (Diabetes Nephropathy, Diabetic retinopathy, Diabetic Neuropathy etc.)
- •9. Poorly controlled Glycemic status (HbA1c greater than 8%)
- •10. Concurrent serious hepatic dysfunction (AST or ALT greater than 3 times of upper normal limit)
- •11. Subjects on steroids, oral contraceptives or estrogen replacement therapy
- •12. Alcoholics and/or drug abusers
- •13. H/O hypersensitivity to any trial drug
- •14. Hypothyroidism or hyperthyroidism
- •15. Patients on vitamin B supplementation
- •16. Patients under other clinical trials for more than 12 weeks
研究者
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