Evaluation of an Ayurvedic medicine for managing diabetes and improving health outcomes linked to chronic high blood sugar

Evaluation of Efficacy and Safety of Ayurvedic Formulation in Managing Madhumeha, Glycaemia, and Clinical Outcomes Secondary to Chronic Glycaemia - None

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097613

Enrollment

Registered

2025-11-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Health Condition 1: E139- Other specified diabetes mellituswithout complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1) Signed and dated informed consent. 2) Age between 30 years to 70 years (both inclusive) 3) Confirmed cases of hyperglycaemia without any comorbidity/complications with random blood sugar between more than equal to 170 mgperdl to less than equal to 250 mgperdl with or without OHAs. 4) Levels of Hb1Ac above 5.7percent. 5) Confirmed cases of three consecutive high blood sugar levels

Exclusion criteria

Exclusion criteria: Patients unwilling to give informed consent. 2) Uncontrolled hyperglycaemia morethan 250 mgperdl with OHA and insulin therapy. 3) Multiple organ failure or ambulatory cases. 4) History of unstable angina, myocardial infarction, cerebrovascular accident, renal/hepatic failure, oncotherapy, high-dose steroids, or severe respiratory disorders. 5) Women with missed menstruation over 3 months, on hormone therapy for pregnancy or known pregnancy cases.

Design outcomes

Primary

Measure	Time frame
Changes in random blood sugar levels. Changes in hyperglycaemia symptoms (weakness (daurbalya), tremors (kampa), tingling (hasthpada chimchimayana), numbness (suktata)). Changes in urination symptoms (urination frequency (muhurmuhu pravritti), burning urination (daha), foaming urination (fena). Changes in HbA1c levels. Changes in fasting plasma insulin. Timepoint: Week 0 screening, week 4, week 12, week 16	—

Measure

Time frame

Changes in random blood sugar levels. Changes in hyperglycaemia symptoms (weakness (daurbalya), tremors (kampa), tingling (hasthpada chimchimayana), numbness (suktata)). Changes in urination symptoms (urination frequency (muhurmuhu pravritti), burning urination (daha), foaming urination (fena). Changes in HbA1c levels. Changes in fasting plasma insulin. Timepoint: Week 0 screening, week 4, week 12, week 16

—

Secondary

Measure	Time frame
Changes in BMI. Changes in lipid profiles. Safety monitoring (Adverse events) Timepoint: Week 0 screening, week 4, week 12, week 16	—

Countries

India

Contacts

Public ContactDr Baidyanath Mishra

Dabur Research and Development Centre Dabur India limited

baidyanath.mishra@dabur.com911203378606

Outcome results