The combination of Berberis aristata and Phyllanthus emblica extract in the management of prediabetes.

Not Applicable

• Conditions: Health Condition 1: R739- Hyperglycemia, unspecified

• Registration Number: CTRI/2024/06/068301
• Lead Sponsor: Pharmanza Herbal Pvt. Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male and females aged 20 to 60 years (both inclusive); 2. Participants with BMI greater than or equal to 25.00 and less than or equal to 34.9 kg/meter square at screening (Overweight to obese class I); 3. Participants with Hemoglobin A1c (HbA1c) greater than or equal to 5.7 % and less than or equal to 6.4%; 4. Participants with Fasting Plasma Glucose (FPG) between 100-125 mg/dl (both inclusive), 2 hours glucose value between 140-199 mg/dl (both inclusive); 5. IDRS (Indian Diabetics Risk score) less than or equal to 60; 6. Participants providing voluntary, written informed consent to participate in the study.

Exclusion Criteria

1. Participants with type 1 or type 2 diabetes mellitus gestational diabetes or secondary diabetes;

2. Participants with any other co-morbidity;

3. Participants treatment of a glucose-lowering or weight loss agent within 90 days before screening;

4. Participants with elevated liver enzymes AST and or ALT greater than 3 times of the upper normal limit;

5. Participants with abnormal renal function as measured by eGFR less than 45ml per min per 1.73 meter square;

6. Participants who had bariatric surgery;

7. Pregnant or lactating women;

8. Smokers alcoholics and or drug abusers;

9. Participants with a known history or ongoing malignancy;

10. Participants with the treatment of immunosuppressive medications in the past three months;

11. Participants suffering from major systemic illness necessitating medical care;

12. Any other reason that can affect the participation of the subject in the study as per investigators discretion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified