Efficacy of Ayurvedic formulations in pre diabetes and Type 2 Diabetes

Randomized active comparator controlled clinical trial of selected Ayurvedic formulations in pre diabetes and Type 2 Diabetes - No Acronym

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/073058

Enrollment

324

Registered

2024-08-28

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Subjects of either sex Group A type 2 diabetes drug naive HbA1c 7 to 9 percentage Group B Type 2 diabetes on metformin monotherapy HbA1c 7 to 9 percentage Group C prediabetes drug naive HbA1c 5.7 to 6.4 non hypertensive or controlled hypertensive agree for written informed consent

Exclusion criteria

Exclusion criteria: type 1 diabetes mellitus diabetic complications, hypertension Hb less than 10 pregnant and lactating women LFT RFT TSH and lipid profile under abnormal limits psychiatric illness

Design outcomes

Primary

Measure	Time frame
changes in HbA1c glycated serum protein albuminTimepoint: Baseline and at 1 3 6 12 18 and 24 months	—

Secondary

Measure	Time frame
Change in cystinallated truncated and di or tri oxydised albumin changes in HOMA 2 IR and HOMA 2 B Changes in FBS PPBS lipid profile LFT HSCRP Sr Creat e GFRand urine albumin creatinine ratio Change in DSQ and ASQ scoresTimepoint: baseline and at 1 3 6 12 18 and 24 months	—

Countries

India

Contacts

Public ContactDr S Srikanta

Samatvam Science and Research for Human Welfare Trust

samatvam@gmail.com8026493040

Outcome results