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临床试验/CTRI/2018/05/013775
CTRI/2018/05/013775招募中未知

A PROSPECTIVE, COMPARATIVE, RANDOMIZED STUDY TO ASSESS THE EFFICACY AND SAFETY OF SNEC30 (CURCUMA LONGA) CAPSULES IN THE TREATMENT OF TYPE 2 DIABETES

Arbro Pharmaceuticals Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Pms

入排标准

入选标准

  • 1 Subject or his legally accepted representative is willing to give informed consent
  • 2 Patients of either sex between the age group 18 to 65 years (both inclusive)
  • 3 Suffering from diabetes type 2 ( between 1 to 10 years)
  • 4 Patients with diabetes who administer oral hypoglycemic agents
  • 5 Patients with HbA1c between 7.0-9.5 %.

排除标准

  • 1 Patients suffering from any of the following conditions will be excluded from the study:
  • a Type 1 diabetes mellitus
  • b Patients with severe hyperglycemia (FBS >234 mg% or PPBS > 360 mg%)
  • c Patients with fasting serum cholesterol >260mg% and serum Triglycerides >300 mg%.
  • d Patients with HbA1c more than 9.5 %.
  • e Patients with AST and ALT levels greater than
  • 2 5 times the upper normal limits
  • f Severe renal, hepatic or respiratory disorder.
  • g Patients with psychiatric disorder.
  • h Patients with haematological disorders
  • I History of smoking (more than 10 cigarettes/day) or alcohol intake > 20 gm/day.
  • j Complications of diabetes such as;
  • Proliferative type retinopathy
  • Nephropathy with laboratory values greater than 1.5 times the upper normal limits
  • Presence of ketone bodies in urine analysis
  • Ischemic heart disease with any cardiac event in last 6 months
  • Fasting serum cholesterol >260mg. % and serum Triglycerides >300 mg%.
  • 2 Patients with BMI >35 kg/m2
  • 3 Patients who are likely to undergo surgery during the study period.
  • 4 Patients who have participated in any investigational study in the last 4 weeks.
  • 5 Patients having known hypersensitivity to the study drugs.
  • 6 Patients with any severe infection
  • 7 Patients with a history of intake of ANY Ayurveda/herbal/homeopathic/dietary supplements (including Vitamin E) or any alternative therapies in the last one month
  • 9 Pregnant or lactating females and women in child bearing age refusing to use contraceptives.

研究者

发起方
Arbro Pharmaceuticals Pvt Ltd

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