Compare the effect of a herbal Siddha formulation Avirai Kudineer on glycosilated haemoglobin in pre-diabetic and diabetic individuals

Comparative study on the changes in HBA1c levels in pre-diabetic and diabetic individuals treated with Siddha formulation Avirai Kudineer â?? A non randomized open clinical study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/06/003784

Enrollment

Registered

2013-06-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Diabetes It is defined as the subjects with the HbA1c 6.% or higher estimation Prediabetes It is defined as the study subjects with the HbA1c 5.7%-6 %

Interventions

Intervention1: Avirai Kudineer: 60ml per oral twice daily for 90 days Control Intervention1: Not applicable: Nil

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed with or without clinical symptoms HbA1c : 5.7% - 6.% lFG 100 â?? 125 mgs/d in group 1 without exposure to anti-diabetic treatment HbA1c: 6.5% PPBS > 126 or higher in group 2 with or without prior anti- diabetic treatment Post prandial blood sugar

Exclusion criteria

Exclusion criteria: Existing renal failure and elevated serum creatinine levels Pregnant and lactating women Age known hepatic and cardiac diseases Subjects those who are not willing to give informed consent Women those who are planning for pregnancy HbA1c less than 5.7% PP blood sugar >300 mgs/dl

Design outcomes

Primary

Measure	Time frame
Primary: HbA1C decrease with 0.6% from baseline visit to final visit Secondary: Reduction in blood glucose levels from base line to end of the study period Changes in other laboratory parameters. Changes in symptoms score. Change from baseline in Body Weight Timepoint: Primary: HbA1C decrease with 0.6% from baseline visit to final visit Secondary: Reduction in blood glucose levels from base line to end of the study period Changes in other laboratory parameters. Changes in symptoms score. Change from baseline in Body Weight	—

Measure

Time frame

Primary: HbA1C decrease with 0.6% from baseline visit to final visit Secondary: Reduction in blood glucose levels from base line to end of the study period Changes in other laboratory parameters. Changes in symptoms score. Change from baseline in Body Weight Timepoint: Primary: HbA1C decrease with 0.6% from baseline visit to final visit Secondary: Reduction in blood glucose levels from base line to end of the study period Changes in other laboratory parameters. Changes in symptoms score. Change from baseline in Body Weight

—

Secondary

Measure	Time frame
Secondary: Reduction in blood glucose levels from base line to end of the study period Changes in other laboratory parameters. Changes in symptoms score. Change from baseline in Body Weight Timepoint: At day 1 and day 90 , blood glucose other laboratory investigations will be done Clinical parameters will be done on every 15 days.	—

Countries

India

Contacts

Public ContactDr K Rajalakshmi

The Tamilnadu Dr MGR Medical University

herbsiddha@rediffmail.com9840961455

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026