A study to compare the effect of Siddha Medicine along with standard diabetes medicines versus standard medicines alone in managing Type 2 Diabetes

An Open-Label, Randomized Controlled Trial to Determine the Efficacy of Standard Oral Anti-diabetic agents combined with Aavarai Kudineer Tablets Versus Standard Oral Anti-diabetic agents Alone in the Management of Type 2 Diabetes Mellitus at National Institute of Siddha, Chennai - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100055

Enrollment

210

Registered

2026-01-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Intervention1: Aavarai Kudineer Tablet: 2 tablet twice a day or 1 tablet twice a day (1000mg twice a day) Control Intervention1: Biguanides: As per the condition

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: T2DM subjects without target glycemic control glycated hemoglobin HbA1c 7 to 9 aged between 18 and above of either sex, will be considered for the study.

Exclusion criteria

Exclusion criteria: Serious diabetic complications (such as diabetic foot, etc.) History of being allergic to interventions Untreated hyperthyroidism and other diseases which may cause secondary hyperglycemia Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) 3 times upper limit of normal Abnormal renal function Pregnant or lactating women Participation in other clinical trials or administration of any other investigational drugs or devices within 3 months before screening; Significant unstable diseases; Any condition that in the investigators opinion might render the patient unable to participate the trial.

Design outcomes

Primary

Measure	Time frame
Outcome Measure: The average difference in Glycated Hemoglobin (HbA1c) from baseline to 90 days between the groups. Timepoint: Outcome Measure: The average difference in Glycated Hemoglobin (HbA1c) from baseline to 90 days between the groups.	—

Secondary

Measure	Time frame
1.Average Difference in insulin level from baseline to 90 days between groups. 2.HOMA-IR Baseline, Day 90 Average Difference in insulin resistance from baseline to 90 days between groups. 3.Lipid Profile Baseline, Day 90 Average Difference in lipid profile parameters from baseline to 90 days between groups. 4.Safety Parameters Throughout study Difference in proportion of Adverse events, lab parameters like LFT, RFT 5.Acceptability Endpoint Proportion of acceptability score at the end of 90 days.Timepoint: Baseline, 90 days	—

Measure

Time frame

1.Average Difference in insulin level from baseline to 90 days between groups. 2.HOMA-IR Baseline, Day 90 Average Difference in insulin resistance from baseline to 90 days between groups. 3.Lipid Profile Baseline, Day 90 Average Difference in lipid profile parameters from baseline to 90 days between groups. 4.Safety Parameters Throughout study Difference in proportion of Adverse events, lab parameters like LFT, RFT 5.Acceptability Endpoint Proportion of acceptability score at the end of 90 days.Timepoint: Baseline, 90 days

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Countries

India

Contacts

Public ContactProf Dr G J Christian

National Institute of Siddha

christianvijila@gmail.com9962545930

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026