A Prospective, Open Label study to evaluate the efficacy of dietary fiber supplement to improve triglycerides and plasma glucose levels in subjects with elevated LDL levels (â?¥ 130 mg/dL and less than 190mg/dL) - Nil

Spectrum Clinical Research Pvt Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.LDL levels (>= 130 mg/dL and < 190mg/dL).
•2.Baseline Triglycerides in the range of > 150mg/dL and < 250 mg / dL
•3.Subject is clinically stable as per P.I. discretion.
•4.Type 2 diabetes (diagnosed with type 2 diabetes for at least six (6) months and currently controlling their blood glucose levels using stable oral hypoglycaemic agents)
•5.Fasting blood glucose values up to 140 mg/dL and PP > 140 mg/dL.
•6.Patient with body mass index of >18.5kg/m 2 and < 25 kg/m2.
•7.Willing to take the dietary fibre as prescribed and sign an inform consent document for participation in the study.

•1.Subjects on lipid lowering drugs.
•2.Diabetic (Type1).
•3.HbA1c > 7.5 %
•4.Patients in the last one month with
•A)any major illness requiring hospitalization
•B)acute exacerbation of any ongoing chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc. Medications requiring change of doses for treatment of the chronic illness
•5.Patients suffering from severe cardiac, renal, liver or any other organ impairment.
•6.History of seizures, epilepsy or any neurological disorders.
•7.Use of any recreational drug or a history of drug addiction.
•8.Patients taking laxatives more than twice a month & /or for last 3 months
•9.Patients smoking more than 10 cigarettes/day
•10.Patients consuming more than 20 gm alcohol per day
•11.Pregnant and lactating women
•12.Athletes or patients who do exercises every day
•13.Patients who are on caloric reduction diet / change dietary constituents frequently.
•14.Patients with auto-immune disorder like Celiac Sprue or Celiac Disease
•15.Patients suffering from Mal-Absorption Syndrome
•16.Patients who are unlikely to comply with Protocol requirements e.g. uncooperative attitude, patients who are frequent travellers, inability to return for the final visit
•17.Patients having Tuberculosis (TB)
•18.Patient participating in any other clinical trial.

发起方

Spectrum Clinical Research Pvt Ltd