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Clinical Trials/CTRI/2023/03/050816
CTRI/2023/03/050816
Not yet recruiting
未知

Evaluating the potential mechanism and efficacy of shodhana-rasayana in comparison with Diabetic Specific Diet and Lifestyle modifications in the management of Madhumeha (Diabetes Mellitus Type 2)on fecal metagenomics - An in-silico and randomized comparative clinical study

All India Institute of Ayurveda, CoE TRISUTRA CSIR IGIB0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: E119- Type 2 diabetes mellitus without complications
Sponsor
All India Institute of Ayurveda, CoE TRISUTRA CSIR IGIB
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

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

Investigators

Sponsor
All India Institute of Ayurveda, CoE TRISUTRA CSIR IGIB

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with Diabetes Mellitus according to WHO criteria
  • Subjects diagnosed for Madhemha based on general diagnostic criteria according to document of Protocol for Prevention and Control of Diabetes through Ayurveda, MoA, Page no 37, 2016
  • Recently diagnosed (0\-5 years) patients who are not on OHA (both overweight/obese and normal BMI â?? ICMR Asian criteria \#)
  • Subjects of either gender aged more than 18 years, \<60 yrs.
  • Willingness to consent to randomization

Exclusion Criteria

  • Emergency cases of diabetes or under immediate consideration for hospitalization and Type 1 DM or Insulin\-dependent
  • Patient with inflammatory bowel disease Crohns disease or ulcerative colitis, chronic diarrhoea or malabsorption Hepatitis etc
  • Patient with a history of other complications with DM
  • Female patient who is pregnant, or breast feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication
  • Patients having known hypersensitivity to any of the proposed trial drug
  • Currently under any other trial

Outcomes

Primary Outcomes

Not specified

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