Efficacy of Indian Ayurvedic Formulation Haemogrit Vital in subjects with Anemia: A Single-Arm, Open-Label, Prospective, Interventional Study - NI

Patanjali Research Foundation governed by Patanjali Research Foundation Trust0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•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.

•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.

发起方

Patanjali Research Foundation governed by Patanjali Research Foundation Trust