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临床试验/CTRI/2018/06/014383
CTRI/2018/06/014383已完成1 期

A comparative study of the effect of Chhinnavahni Kashaya Vati along with Agnimantha Kwatha and Metformin in the management of Madhumeha w.s.r. to Diabetes Mellitus (Type-II)

Ayurvedic and Unani Tibbia College0 个研究点目标入组 60 人开始时间: 待定最近更新:

试验速览

阶段
1 期
状态
已完成
入组人数
60

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 sex aged between 20 to 60 years.
  • 2.If yes in any two of the four:
  • a)Blood sugar â??fasting > 126 and <= 250 mg/dl.
  • b)PP > 200 mg/dl and <=350 mg/dl.
  • c)Glycosylated Haemoglobin (HbA1c) > 6.5% and < 9%.
  • d)Subjects having classical symptoms of diabetes with random glucose levels >=200mg/dl (<=350mg/dl).
  • 3.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-B)}.
  • 4. Subjects who are able to come for follow up on fixed visits and are well aware about the treatment plan.
  • 5.Subjects willing to participate and able to provide written informed consent.

排除标准

  • 1.Age below 20 and above 60yrs.
  • 2.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.
  • 3.Subjects suffering from the complications of Diabetes mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy etc. which require an urgent treatment.
  • 4.Uncontrolled Hypertensive subjects (BP with or without medication >140/90 mmHg after 5 mins of rest).
  • 5.Subjects with any unstable Heart disease or known cases of MI, unstable angina or CHF.
  • 6.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).
  • 7.Subjects with current or past diagnosis of malignancy (any malignancy diagnosis in last five years).
  • 8.Subjects who have a recent history or who are currently known to abuse of alcohol or drugs.
  • 9.Subjects suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, TB, AIDS etc).
  • 10.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.
  • 11.Pregnant / Lactating women.
  • 12.Subject on systemic or oral steroids, oral contraceptive pills or estrogen replacement therapy.
  • 13.Subjects having hypersensitivity to any of the trial drug.
  • 14.Subjects who have completed participation in any other clinical trial during the past six (06) months.

研究者

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