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Clinical Trials/CTRI/2013/04/003553
CTRI/2013/04/003553
Completed
Phase 2

An Open Labeled, Multicenter, Prospective, Clinical Study to Evaluate the Suitability for Consumption of Chyawanprakash in Controlled Type II Diabetic Patients. - NI

Dabur Research Development Centre DRDC0 sites120 target enrollmentTBD
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ConditionsHealth Condition 1: null- Type 2 Diabetes mellitus

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: null- Type 2 Diabetes mellitus
Sponsor
Dabur Research Development Centre DRDC
Enrollment
120
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Dabur Research Development Centre DRDC

Eligibility Criteria

Inclusion Criteria

  • •1\.Subjects suffering from Type II Diabetes Mellitus for more than one year, and stabilized on either exercise/diet regimen or mono / polydrug oral anti\-diabetic therapy.
  • •2\.Subjects having HbA1c value below 8% at screening.
  • •3\.Subjects having Fasting Plasma Glucose 90 \-150 mg/dl (both inclusive) and postprandial glucose in the range of 110\-180 mg/dl at screening.
  • •4\.Subjects of female gender or non\-pregnant, non\-lactating females, at least six weeks postpartum. A urine pregnancy test is required for all female subjects of childbearing potential unless subject has had a hysterectomy, tubal ligation, or is \> 2 years postmenopausal.
  • •5\.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

Exclusion Criteria

  • •1\.Subjects on Insulin therapy.
  • •2\.Subjects suffering from Type I DM or type of Diabetes mellitus other than Type II.
  • •3\.Subjects having known hepatic or renal disease.
  • •4\.Subjects having an active malignancy.
  • •5\.Subjects giving history of significant cardiovascular event \< 12 weeks prior to randomization.
  • •6\.Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
  • •7\.Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
  • •8\.Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
  • •9\.Subjects using any other investigational drug within 1 month prior to recruitment
  • •10\.Known hypersensitivity to any of the ingredients used in study drug

Outcomes

Primary Outcomes

Not specified

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