An Open-Label, Single-Arm, Single-Centered Clinical Study To Evaluate The Safety And Efficacy Of Hb Vista Ayurvedic Capsule In Patients With Anaemia.

Introduction and Background:

Anaemia is recognized as a common clinical condition characterized by reduced haemoglobin levels or red blood cell count, leading to diminished oxygen-carrying capacity and symptoms such as fatigue, weakness, and dizziness. It commonly occurs due to nutritional deficiencies, chronic illnesses, or genetic disorders. Conventional treatments, although effective, are often associated with gastrointestinal side effects or do not address the underlying causes in all patients. HB Vista Ayurvedic Capsule is a polyherbal formulation containing Emblica officinalis (Amla), Phyllanthus niruri (Bhumi Amla), Kasis Bhasma, and Mandur Bhasma, which has traditionally been used in Ayurveda for their haematinic, iron-enhancing, and liver-supportive properties. Although the product is available in the market, systematic clinical evidence regarding its efficacy and safety in anaemic patients is lacking.

Purpose of the Study:

The primary purpose of this open-label, single-arm, single-centered clinical study was to evaluate the safety and efficacy of HB Vista Ayurvedic Capsule in patients with anaemia. The study assessed the change in haemoglobin concentration from baseline to the end of the treatment period, evaluated improvements in patients’ quality of life using a validated QoL scale, and monitored adverse events throughout the study. This post-marketing clinical trial aimed to generate scientific evidence supporting the use of HB Vista as a safe and effective Ayurvedic treatment for anaemia.

Summary of Results:

The clinical study evaluated the safety and efficacy of HB Vista Ayurvedic Capsule in 60 anaemic patients over a 60-day period. All enrolled subjects completed the study, with no dropouts or withdrawals. The study enrolled 38 female and 22 male Subjects. The primary efficacy endpoint demonstrated a statistically significant increase in mean haemoglobin levels from 6.09 g/dL at baseline to 13.05 g/dL at Day 60 (p < 0.00001), which was a steady and significant rise reflecting a 95.8% improvement. This indicated a strong and consistent haematinic effect of the intervention.

Secondary outcomes showed substantial improvements in quality of life (QoL) across physical, emotional, social, and occupational domains. Participants reported increased energy, reduced physical discomfort, enhanced emotional well-being, improved social engagement, and greater satisfaction with work and daily responsibilities. The average self-assessment of overall physical health showed a significant improvement and number of Subjects who could perform their daily activities without difficulty increased from 9 to 30. Reports of Physical Discomfort dropped sharply and all the Subjects acknowledged improved health condition. Similarly, there was positive shift in emotional wellness and reduced psychological distress with enhanced quality of life in Subjects. Also, the study demonstrated enhanced social activities by the Subjects, greater connection with others and increased satisfaction in personal relationships by the end of the study. The work-life balance also improved with none of the Subjects reporting missing work due to health issues at the end of the study. The study also reported significant improvements in complete blood count (CBC) parameters, including RBC, MCV, MCH, and MCHC levels, indicating improved red blood cell production and oxygen-carrying capacity.

No adverse events (AEs) or serious adverse events (SAEs) were reported throughout the study period. Liver and renal function parameters remained within normal ranges, and lipid profile analysis showed beneficial shifts in HDL, LDL, and triglyceride levels. The study reported 100% treatment compliance among participants.

These results confirmed that HB Vista Ayurvedic Capsule is both safe and effective in the management of anaemia and significantly improved patients’ overall quality of life.