Clinical evaluation of an Ayurvedic formulation, Drakshavaleha, in the management of iron deficiency anemia: An open-label prospective clinical study
Kavita Vyas, Chris Antony, Vikas Nariyal, Babita Yadav, Bhogavalli Chandra Shekhar Rao, Bhagwan Sahay Sharma, Shruti Khanduri, Rakesh Rana, Arunabh Tripathi, Narayanam Srikanth, Kartar Singh DhimanAbstract
BACKGROUND:
Iron deficiency anemia (IDA) is the most common nutritional deficiency globally and continues to pose a significant public health challenge, particularly among women of reproductive age. While oral iron supplementation remains the standard treatment, gastrointestinal side effects and poor treatment adherence often compromise its effectiveness in routine practice, underscoring the need for safe, well-tolerated therapeutic options.
OBJECTIVE:
This study aimed to evaluate the clinical effectiveness and safety of DA in the management of IDA.
MATERIALS AND METHODS:
This prospective, open-label interventional study enrolled 65 adults (18–60 years) with IDA from the outpatient department of Regional Ayurveda Research Institute, Mandi, Himachal Pradesh, between December 2018 and December 2021. Participants received 10 g of DA twice daily on an empty stomach with lukewarm water for 84 days and were evaluated every 14 days during the treatment period. Hematological and iron status parameters, including hemoglobin, serum ferritin, serum iron, total iron-binding capacity (TIBC), mean corpuscular volume (MCV), reticulocyte count, and red blood cell count, were assessed at regular intervals, along with monitoring for adverse events (AEs). A post-treatment follow-up was conducted on Day 112 using the same outcome measures.
RESULTS:
Of the 65 participants enrolled, 34 completed the study and were included in the final analysis, while the remaining participants were lost to follow-up, primarily due to disruptions caused by the Coronavirus disease pandemic. Treatment with DA resulted in significant improvements in hematological and iron status parameters over 84 days. Mean hemoglobin increased from 9.22 ± 0.66 g/dL at baseline to 10.39 ± 0.53 g/dL (
CONCLUSION:
DA was associated with significant improvements in hematological and iron status parameters in adults with IDA and was well tolerated throughout the study period, with no serious AEs reported. These findings suggest that DA may be a safe and promising therapeutic option for the management of IDA. However, larger randomized controlled trials are warranted to confirm its efficacy and establish its role in clinical practice.
CTRI REGISTRATION:
CTRI/2018/08/015146 dated January 8, 2018.