Study to evaluate role of Ayurvedic drug Navayasa Churna in the treatment of Anemia

Phase 2

Completed

• Conditions: Health Condition 1: null- CLINICAL EVALUATION OF NAVAYASA CHURNA IN THE MANAGEMENT OF IRON DEFICIENCY ANAEMIA

• Registration Number: CTRI/2017/08/009200
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-09-16
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1) Patients of either sex aged between 18 to 50 years.

2) Patients with iron deficiency anaemia (Hb 8gm-10gm. %),

3) S. Ferritin < 30 μg /L

4) Patients with peripheral blood smear suggestive of Iron deficiency Anaemia

5) Willing and able to participate for 120 days.

Exclusion Criteria

1. Patients suffering from Thalassemia major / Aplastic anaemia / Sickle cell anaemia.

2. Patients with evidence of malignancy.

3. Stool examination found with positive ova/cyst/parasite of worm infestation.

4. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, Bleeding disorders, etc.)

5. Patients who have a past history of Atrial Fibrillation, Coronary Artery Disease (CAD), Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

6. Symptomatic patient with clinical evidence of Heart failure.

7. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg)

8. Patients suffering from Diabetes Mellitus (F.B.S. > 250 mg/dl.)

9. Patients on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.

10. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino

Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit), or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Total Serum Cholesterol & / or Serum Triglycerides > 250 mg/dl, Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]).

11. Alcoholics and/or drug abusers.

12. Pregnant / lactating woman

13. H/o hypersensitivity to the trial drug or any of its ingredients.

14. Patients who have completed participation in any other clinical trial during the past six (06) months.

15. Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified