A Clinical trial to study the effects of a unani formulation 'Diabeat'in patients with high blood sugar levels (Type 2 diabetes mellitus )

A clinical study of a herbal formulation 'Diabeat' as an adjuvant drug for the control of type 2 diabetes mellitus

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000702

Enrollment

Registered

2009-09-10

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

None listed

Interventions

Intervention1: Diabeat: 2000 mg for 3 months in divided doses Control Intervention1: Placebo: 2000 mg for 3 months in divided doses

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of type-2 diabetes mellitus, age 30-60 years taking Metformin for more than 3 months with uncontrolled hyperglycaemia i.e.HbA1C between 7% to 9% and Body Mass Index (BMI) between 25-29.9 kg/m2. 2. Patients who are able and willing to follow anti-diabetic therapy under a stable life style and diabetic diet. 3.Patients who are willing and able to understand and follow the protocol and provide informed consent.

Exclusion criteria

Exclusion criteria: 1.History of treatment with any insulin 2.Diabetes mellitus with complications 3.Pregnant or Lactating women 4.Women of childbearing potential who do not take adequate contraceptive protection. 5.History of hypersensitivity to the Metformin or to drug with similar chemical structure. 6.History of any severe systemic disease. 7.Patients with uncontrolled hypertension. 8.History of drug or alcohol abuse.

Design outcomes

Primary

Measure	Time frame
Mean HbA1C 6.5%Timepoint: 12 weeks	—

Secondary

Measure	Time frame
To achieve a good glycemic control (FPG-80-120 mg/dl; PPG-80-140 mg/dl)Timepoint: 4,8,12 week	—

Countries

India

Contacts

Public ContactDr Yasmeen Shamsi

Dept. of Moalajat SUMER

yasmeen.ijum@gmail.com26059692

Outcome results