Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 26, 2025
Open Peer Review Period: Apr 28, 2025 - Jun 23, 2025
Date Accepted: Aug 26, 2025
(closed for review but you can still tweet)
EFFICACY OF AN AYURVEDIC INTERVENTION AS AN ADJUNCT TO STANDARD CARE IN PREVENTING ACUTE PAIN CRISES IN SICKLE CELL ANEMIA: PROTOCOL OF A RANDOMIZED CONTROLLED TRIAL
ABSTRACT
Background:
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, though it is associated with several side effects. Therefore, considering the urgent need for an accessible, safe, and effective alternative for long-term management of the condition, the present study is planned to evaluate the potential of Ayurveda in managing pain crises in conjunction with conventional standard care.
Objective:
The study aims to evaluate the efficacy of Ayurvedic formulations in preventing acute pain crises in SCA and improving the quality of life of affected individuals.
Methods:
It is a randomized active, controlled, open-label clinical trial. Patients diagnosed with SCA are enrolled in the study, considering the selection criteria. The study group is administered Ayurvedic interventions such as Dadimadi Ghrita and Ayush-RP along with the standard care, while the control group receives standard care only. The intervention is given for a period of 8 months. Participants are evaluated on the 30th day, 60th day, 105th day, 150th day, 195th day and 240th day to assess changes in pain crisis frequency, haemoglobin levels, and quality of life improvements.
Results:
The study has been initiated on 5th September 2023. Out of the total 1518 screened participants, 1371 enrolled, 791 participants have successfully completed, 498 participants are continuing while 82 participants dropped out from the study as of 22nd January 2025.
Conclusions:
The study is expected to demonstrate the efficacy and safety of Ayurvedic interventions as an integrated approach in managing SCA by reduction in the frequency of pain crises, aiming to improve the overall quality of life for the patients. Clinical Trial: CTRI/2023/04/052141
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