# Efficacy of an Ayurvedic Intervention as an Adjunct to Standard Care in Preventing Acute Pain Crises in Sickle Cell Anemia: Protocol for a Randomized Controlled Trial

## TL;DR

This study tests if Ayurvedic treatments can help reduce pain crises in sickle cell anemia patients when used with standard care.

## Contribution

The study introduces a novel randomized trial of Ayurvedic interventions for managing sickle cell anemia pain crises.

## Key findings

- 1510 participants were enrolled, with 1137 completing the 8-month study.
- Ayurvedic interventions were evaluated for their impact on pain crisis frequency and quality of life.
- 24.62% of participants were still in the study as of August 2025.

## Abstract

Sickle cell anemia (SCA) represents a major health concern among the tribal population of India, with frequent acute pain crises significantly compromising the quality of life of the affected individuals. As an inherited disorder, there is no definitive cure for the condition. Hydroxyurea remains the primary therapeutic option and is typically used for lifelong management, although it may be associated with certain side effects. In light of the pressing need for a safe, accessible, and effective alternative for long-term care, this study is planned to explore the potential of Ayurveda in managing pain crises alongside conventional standard care.

This study aims to evaluate the efficacy of Ayurvedic intervention in preventing acute pain crises in individuals with SCA and improving their quality of life.

This study is designed as a randomized, active-controlled, open-label clinical trial. Participants diagnosed with SCA are enrolled in the study according to the selection criteria. The intervention group receives Ayurvedic interventions, namely dadimadi ghrita and Ayush-RP, along with standard care, whereas the control group receives standard care only. The intervention is administered over a period of 8 months. Participants are evaluated on the 30th, 60th, 105th, 150th, 195th, and 240th days to assess changes in the frequency of pain crises and quality of life.

This study was initiated on September 5, 2023. Total enrollment of 1510 participants has been completed by screening 1644 participants. As of August 14, 2025, a total of 1137 participants have successfully completed the study, 280 (24.62%) are continuing, and 93 (8.18%) have dropped out.

This study aims to establish the efficacy and safety of Ayurvedic interventions as part of an integrated approach to managing SCA, with a focus on reducing the frequency of pain crises and improving patients’ overall quality of life.