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Clinical Trials/CTRI/2020/09/028006
CTRI/2020/09/028006Not yet recruitingPhase 2

Efficacy of Aardra and Shushka Guduchi [Tinospora cordifolia (Willd) Miers] in the management of Madhumeha (Type-II DM): A Comparative open label Randomized controlled clinical trial

All India Institute of Ayurveda0 sites0 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •1. Recently diagnosed (less than 1 year of diabetic history) cases of Type-2 DM and not taking any antidiabetic drug/Insulin since 2 months
  • •2. Including both Pre-diabetes and diabetes cases
  • •Fasting Blood Sugar (FBS) ranges between 100 to 125 mg/dl in pre-diabetes and greater than 126 mg/dl to less than equal to 200 mg/dl in diabetes cases.
  • •Post Prandial Blood Sugar (PPBS) ranges between
  • •140 to 199 mg/dl in Pre-diabetes and greater than 200 mg/dl to less than equal to 350 mg/dl in diabetes cases.
  • •HbA1c ranges between 5.7 % to 6.4 % in Pre-diabetes and greater than equal to 6.5 % to less than equal to 8 % in diabetes cases.
  • •3. Presence of urine sugar
  • •4. Frequency of urination 7 to 10 times per 24 hours and quantity and quantity greater than equal to 2500 ml
  • •5. Accidentally diagnosed cases of Type-2 DM who visit the hospital for other complaints

Exclusion Criteria

  • •1. Cardiovascular disorder with Type-2 DM
  • •2. Malignant and accelerated Hypertensive
  • •3. Pregnant woman and planning to be pregnant within 6 months
  • •4. Lactating mother
  • •5. Secondary Diabetes Mellitus
  • •6. Patients undergoing regular treatment for diabetes or any other severe illness
  • •7. CNS Disorder e.g. Encephalopathy
  • •8. Subjects already suffering from the complications of Diabetes (Diabetes Nephropathy, Diabetic retinopathy, Diabetic Neuropathy etc.)
  • •9. Poorly controlled Glycemic status (HbA1c greater than 8%)
  • •10. Concurrent serious hepatic dysfunction (AST or ALT greater than 3 times of upper normal limit)
  • •11. Subjects on steroids, oral contraceptives or estrogen replacement therapy
  • •12. Alcoholics and/or drug abusers
  • •13. H/O hypersensitivity to any trial drug
  • •14. Hypothyroidism or hyperthyroidism
  • •15. Patients on vitamin B supplementation
  • •16. Patients under other clinical trials for more than 12 weeks

Investigators

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