Effectiveness of Ayurvedic Formulation Patanjali Haemogrit Vital in subjects with Anemia.

Not Applicable

• Conditions: Health Condition 1: D509- Iron deficiency anemia, unspecified

• Registration Number: CTRI/2023/09/057653
• Lead Sponsor: Patanjali Research Foundation governed by Patanjali Research Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Adult male and female population having mild or moderate anemia defined as follows:

Hb levels: Female: mild: 11.0-11.9 g/dl, moderate: 8.0–10.9 g/dl.; Males: mild: 11.0–12.9 g/dl, moderate: 8.0–10.9g/dl.

2.Subjects aged from 18 years and above.

3. Signed informed consent prior to study specific procedures.

4.Availability and willingness to complete all study visits and procedures per protocol.

Exclusion Criteria

1. Having Sickle Cell Anemia, Thalassemia Minor, Pernicious Anemia, Aplastic Anemia.

2. Having Hemophilia, & Other Hemolytic diseases.

3. Erythropoietin treatment within 8 weeks prior to the screening visit.

4. Pregnancy or Breast Feeding.

5. Chronic inflammation eg. RA, AS, Gastro-intestinal disorders eg. UC, IBD, Hemorrhoids.

6. Having Chronic Kidney Disease, Chronic Liver Disease, Psychiatric Disorders.

7. Any Malignant Conditions eg. Myeloma, Lymphoma etc.

8. Intake of iron preparations 4 weeks prior to screening.

9. Known hypersensitivity to any excipients of the intervention.

10. Participation in any other interventional trial within 4 weeks prior to screening.

11. Patients planning surgery within the trial phase or receiving a blood transfusion a week prior to the screening visit.

12. Inability to fully comprehend and/or perform study procedures or provide written consent in the Investigator’s opinion.

13. Any other medical condition that, in the opinion of the investigator, makes the patient incompetent to participate in the trial or places the patient at potential risk, e.g. any chronic comorbidity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Mean change from baseline in Hemoglobin levels at Day 60.Timepoint: Baseline, Day 30, Day 60

Secondary Outcome Measures

Name	Time	Method
Mean Changes in MFSI-SF, BFI, SF-12, PSQI & also the changes from baseline to Day 60 in CBC Count.Timepoint: Baseline, Day 30, Day 60