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Clinical Trials/CTRI/2021/06/034030
CTRI/2021/06/034030Not yet recruitingNot Applicable

A preclinical and clinical study to determine the efficacy of Neelkanthi Churna in management of Madhumeha w.s.r to Type 2 Diabetes Mellitus

Principal1 site in 1 country30 target enrollmentStarted: June 17, 2021Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Principal
Enrollment
30
Locations
1
Primary Endpoint
Fulfillment of objective and subjective criteria
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

I would like to publish my research trial after completion of the trial as soon as possible. Patients will selected from OPD & IPD of R.G.G.P.G Ayurvedic College & Hospital Paprola.

3 groups of 30 patients will be registered then assessed to evaluate the efficacy of Neelkanthi Churana in Madhumeha w.s.r Diabetes Mellitus Type 2

Study Design

Study Type
Interventional
Allocation
Other
Masking
Open Label

Eligibility Criteria

Ages
20.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients of either sex aged between 20-70yrs.
  • •Newly diagnosed patients of Type 2 Diabetes Mellitus having glycosylated Hb (HbA1C) between 6.5% to 10% 3) Patients willing to participate in the trial.

Exclusion Criteria

  • •Subject of Type-1 DM or Type-2 DM on insulin/OHA’s other than Metformin/ any other medication for glucose control in the last 3 months Subjects suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy etc.
  • •which require an urgent treatment.
  • •Patients having major medical illness like cancer, concurrent infection like tuberculosis.
  • •Patients with uncontrolled Hypertension.
  • •Patients with established diagnosis of CAD or any other clinically significant cardiovascular disease.
  • •Renal dysfunction (defined by eGFR< 60ml/min calculated by MDRD calculator) Subjects who have completed participation in any other clinical trial during the past 3 months.
  • •Any other condition which the investigator thinks may compromise the safety of subject.
  • •Subjects with Haemoglobin percentage < 9gm% for males and < 8gm%for females.

Outcomes

Primary Outcomes

Fulfillment of objective and subjective criteria

Time Frame: 12 weeks

Secondary Outcomes

  • Efficacy of Neelkanthi Churna in type 2 Diabetes Mellitus(12 weeks)

Investigators

Sponsor
Principal
Sponsor Class
Research institution and hospital

Study Sites (1)

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