Study to evaluate the efficacy and safety ofProGo powder to improve hemoglobin and sugar levels in elderly anaemic patients.

Phase 4

Completed

• Conditions: Health Condition 1: null- Anaemia.

• Registration Number: CTRI/2013/04/003528
• Lead Sponsor: Spectrum Clinical Research Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Understand and voluntarily sign an informed consent form.

2. Age 50 years and older.

3. Able to adhere to the study visit schedule and other protocol requirements.

4. Women with Hemoglobin concentration >= 10 g/dL and < 12 g/dL and men with >= 11 g/dL and < 13 g/dL.

5. Situational anemia.

Exclusion Criteria

1. Red blood cell transfusions within the past 3 months.

2. Estimated glomerular filtration rate (eGFR) of < 30 ml/min (by abbreviated MDRD).

3. Use of erythropoiesis stimulating agents (ESA) in the past 3 months.

4. Active infection defined as symptomatic, requiring active treatment (prophylaxis allowed) or hospitalized for > 24 hours primarily for infection within the past month.

5. Uncontrolled hypertension defined as diastolic blood pressure > 100 mm Hg or systolic blood pressure > 160 mm Hg on 2 separate occasions during screening period.

6. Other primary uncorrected cause for anemia including:

a. Known active inflammatory disease including autoimmune diseases (e.g., systemic lupus

erythematosis, rheumatoid arthritis, mixed connective tissue disease, sarcoidosis, bronchiolitis obliterans, vasculitis, polymyalgia rheumatica, temporal arteritis).

b. Chronic active infection (e.g., HIV, viral hepatitis).

c. Acute infection within past 3 months (pneumonia, sepsis, bacteremia, prostatitis).

d. Receipt of immunosuppressive therapy in the past 2 years.

e. Any cancer (aside from nonâ??melanoma skin cancer) in the past 2 years or on therapy for cancer.

7. Elevated AST or ALT >= 2x upper limit of normal.

8. Total bilirubin > 1.5 mg/dL.

9. Use of any other experimental drug or therapy within 28 days of initial screening visit.

10. Subjects expected to consume nonâ??steroidal anti inflammatory drugs (NSAIDs), corticosteroids,

methotrexate, furosemide or anticoagulants during the course of this study.

11. Elevated TSH, or other signs of hypothyroid condition.

12. History of cerebral vascular accident, a clinical diagnosis of angina or myocardial infarction, any coronary interventions (PCI, Bypass, Stent placement) within the prior 12 months to reduce the risk of subject requiring

aspirin therapy during the trial.

13. Dementia defined as the inability to independently provide informed consent.

14. Recent history of gastrointestinal bleed.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the effect of ProGo powder to improve hemoglobin in elderly anemic male and female patients.Timepoint: 30 Days from Baseline Visit.

Secondary Outcome Measures

Name	Time	Method
To determine the efficacy of ProGo powder on following <br/ ><br>parameters: <br/ ><br>1. Plasma glucose levels. <br/ ><br>2. Quality of life improvement.Timepoint: 30 Days from Baseline Visit.