A clinical study to evaluate anti-diabetic effect and other health benefits of guava leaf extract in patients with diabetes mellitus
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2021/09/036656
- Lead Sponsor
- JIPMER Puducherry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients with type 2 Diabetes mellitus aged 18 years and above, irrespective of gender, who fulfil the following criteria -
Patients on treatment with stable dose of oral hypoglycaemic agents for atleast 2 months and have not yet attained target HbA1c goal of less than 7% and not requiring dose escalation or addition of second anti-diabetic agent according to clinical judgment of the treating physician
• Patients on/requiring insulin therapy.
• Patients not on stable dose of oral hypoglycemic drugs for past 2 months
• HbA1c >9%
• Pregnant and lactating women, women in reproductive age group not practicing contraceptive measures.
• Patients with hepatic impairment (elevated liver enzymes >2 times upper normal limit)
• Patients with renal impairment (S.Creatinine > 1.2 mg/dL)
• Patients with recent history of Coronary artery disease within past 6 months.
• Patients with peripheral vascular disease.
• Patients who had participated in other trials in the past three months.
• Patients on other herbal medications.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method