Currently submitted to: JMIR Research Protocols
Date Submitted: Aug 27, 2026
Open Peer Review Period: Aug 28, 2026 - Oct 23, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Efficacy and safety of Punarnavadi Mandura and Dadimadi Ghrita versus standard care in Adolescents with Iron Deficiency Anaemia in Improving Haemoglobin level, Functional gut well-being and Cognitive Performance- Study Protocol for a Prospective Randomized Active Controlled Trial
ABSTRACT
Background:
Anaemia is clinically defined as a haemoglobin concentration below two standard deviations from the age- and sex-specific mean (WHO, 2011). Iron deficiency anaemia (IDA) is the predominant subtype, responsible for ~50% of global anaemia cases, with a higher prevalence in developing nations. In adolescents, IDA is associated with impaired neurodevelopment, reduced academic performance, diminished physical capacity, and compromised immunity. Conventional management relies on oral iron and folic acid (IFA) supplementation, often limited by poor adherence and gastrointestinal intolerance. Ayurvedic formulations Punarnavadi Mandura (PM) and Dadimadi Ghrita (DG) have traditionally been used in combination to improve iron metabolism, gut health, and vitality.
Objective:
To evaluate the efficacy of PM and DG on haematological parameters, functional outcomes, and general wellbeing in adolescents with IDA, and to assess their safety and tolerability
Methods:
This prospective, randomized, active-controlled trial will enroll 150 adolescents with IDA, randomized (1:1) to either conventional care (IFA supplementation) or Ayurvedic intervention (PM + DG) for 12 weeks. Primary endpoints include changes in haemoglobin and red cell indices (MCHC, MCV, MCH). Secondary endpoints include serum iron, ferritin, TIBC, TSAT, Montreal Cognitive Assessment scores, R4PDQ, HR-QoL, and symptom resolution. Safety will be assessed via AE/ADR monitoring, liver and renal function tests, and adherence through compliance checks.
Results:
...
Conclusions:
This study will provide evidence on the efficacy and safety of PM and DG as a standalone intervention for adolescents with IDA. Findings may support the use of these Ayurvedic formulations as an evidence-based therapeutic option to improve haematological parameters, cognitive function, and overall wellbeing in this population, potentially informing clinical practice and future research on these interventions.. Clinical Trial: The trial is prospectively registered with the Clinical Trial Registry of India (CTRI/2023/05/052496) dated 11.05.2023
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