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

Recruiting

• Conditions: Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH,

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

Brief Summary

This study is a single-arm, open-label, prospective, interventional study. In this study, 100 participants will be enrolled aged 18 years and above. Participants will receive intervention with medication for 60 days. The primary outcome involves Mean change from baseline in Hemoglobin levels at Day 60 and secondary outcome involves Mean changes in MFI-SF, BFI, SF-12, PSQI.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-25
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

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.
• Signed informed consent prior to study specific procedures.
• 4.Availability and willingness to complete all study visits and procedures per protocol.

Exclusion Criteria

• Having Sickle Cell Anemia, Thalassemia Minor, Pernicious Anemia, Aplastic Anemia.
• Having Hemophilia, & Other Hemolytic diseases.
• Erythropoietin treatment within 8 weeks prior to the screening visit.
• Pregnancy or Breast Feeding.
• Chronic inflammation eg.
• RA, AS, Gastro-intestinal disorders eg.
• UC, IBD, Hemorrhoids.
• Having Chronic Kidney Disease, Chronic Liver Disease, Psychiatric Disorders.
• Any Malignant Conditions eg.
• Myeloma, Lymphoma etc.
• Intake of iron preparations 4 weeks prior to screening.
• Known hypersensitivity to any excipients of the intervention.
• Participation in any other interventional trial within 4 weeks prior to screening.
• Patients planning surgery within the trial phase or receiving a blood transfusion a week prior to the screening visit.
• 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.	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.	Baseline, Day 30, Day 60

Trial Locations

Locations (2)

Patanjali Wellness; 🇮🇳 Hardwar, UTTARANCHAL, India

Patanjali Yoggram; 🇮🇳 Hardwar, UTTARANCHAL, India

Patanjali Wellness

🇮🇳Hardwar, UTTARANCHAL, India

Dr Devasena K M

Principal investigator

07012421624

drdevasenabamsmd@gmail.com