CTRI/2020/03/024406尚未招募2 期
clinical evaluation of effect of tryushnadi gutika and mustadi kashaya in the management of madhumeha w.s.r. to diabetes mellitus(type 2)
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
- •Patients of either sex aged between 20 to 65 years.
- •If yes in any two of the four:
- •Blood sugar â??fasting > 126 and <= 250 mg/dl.
- •PP > 200 mg/dl and <=350 mg/dl.
- •Glycosylated Haemoglobin (HbA1c) > 6.5% and < 10%
- •Subjects having classical symptoms of diabetes with random glucose levels >=200mg/dl (<=350mg/dl).
- •Diagnosed cases of Type II Diabetics having Glycosylated Haemoglobin (HbA1c) between 6.5-9% without or {with metformin in a dose1g-1.5g/day (for Group-D)}.
- •Subjects who are able to come for follow up on fixed visits and are well aware about the treatment plan.
- •Subjects willing to participate and able to provide written informed consent.
- •Diabetes Mellitus >2 years and <10 years.
排除标准
- •Age below 20 and above 65yrs.
- •Subject of Type-I DM (insulin dependent DM) or Type-II DM on insulin/OHAâ??s other than metformin/ any other AYUSH medication for glucose control.
- •Subjects suffering from the complications of Diabetes mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy etc. which require an urgent treatment.
- •Uncontrolled Hypertensive subjects (BP with or without medication >140/90 mmHg after 5 min. of rest).
- •Subjects with any unstable Heart disease or known cases of MI, unstable angina or CHF.
- •Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction, uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects).
- •Diabetes Mellitus <2 years and >10 years.
- •Subjects with current or past diagnosis of malignancy (any malignancy diagnosis in last five years).
- •Subjects who have a recent history or who are currently known to abuse of alcohol or drugs.
- •Subjects suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, TB, AIDS etc).
- •Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
- •Pregnant / Lactating women.
- •Subject on systemic or oral steroids, oral contraceptive pills or estrogen replacement therapy.
- •Subjects having hypersensitivity to any of the trial drug.
- •Subjects who have completed participation in any other clinical trial during the past six (06) months.
研究者
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