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Integrating an Ayurveda-based Intervention into the Scheme for Adolescent Girls through Anganwadi Centres to Strengthen Anemia Control in Five Aspirational Districts of India: Protocol for a Type 1 Hybrid Effectiveness–Implementation Study
ABSTRACT
Background:
Anemia affects 59.1% of girls aged 15–19 years in India despite national initiatives such as Anemia Mukt Bharat (AMB). The Scheme for Adolescent Girls (SAG), delivered through Anganwadi Centers under Saksham Anganwadi and POSHAN 2.0, offers an established platform for nutrition and health education. Evidence on integrating Ayurveda-based interventions into this platform using implementation science approaches remains limited.
Objective:
To evaluate the effectiveness of an integrated Ayurveda-based intervention for anemia delivered alongside routine services under the Scheme for Adolescent Girls (SAG), while assessing its implementation, using a Type 1 hybrid effectiveness–implementation design.
Methods:
This protocol describes a multicenter study in five Aspirational Districts of India, funded through inter-ministerial collaboration. The intervention combines quality-assured Ayurveda medicines (Krimimudgar Rasa, Drakshavaleha, and Punarnavadi Mandoor) with health education and dietary and lifestyle counseling delivered by trained Ayurveda graduates and Anganwadi Workers, alongside unchanged routine AMB and SAG services. The implementation component covers all willing, eligible girls aged 14 to under 18 years at enrollment. The program-level outcomes, assessed in all enrolled girls, are the change in the proportion of non-anemic girls (point-of-care hemoglobin), shift in anemia severity category, change in clinical signs and symptoms (pallor, fatigue, loss of appetite), thinness by body mass index (BMI)-for-age (World Health Organization [WHO] 2007 reference), and the proportion with at least 70% adherence. The effectiveness component is a 3-month, single-group pre–post evaluation of 301 girls per district, assessed independently by a public health institute. The primary outcome is the change in venous hemoglobin, and the co-primary outcomes are the changes in serum ferritin, fatigue (FACIT-F), and appetite scores. Secondary effectiveness outcomes include anemia status and transitions between severity categories, liver and kidney function, serum iron, total iron-binding capacity, and diet. The implementation outcomes (acceptability, appropriateness, feasibility, adoption, fidelity, reach, cost, and sustainability) will be guided by the Consolidated Framework for Implementation Research (CFIR) 2.0, Proctor’s framework, RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance), and the Intervention Scalability Assessment Tool.
Results:
The protocol was sanctioned on March 18, 2024, and its final version was revised on October 29, 2024. Enrollment began on October 25, 2024, in the implementation component (77,633 girls enrolled by June 30, 2025) and on December 21, 2024, in the effectiveness component (1,587 girls across the five districts). Final follow-up was completed on September 30, 2025. Data analysis is ongoing, and results will be reported separately. This manuscript reports the protocol only.
Conclusions:
The study is expected to provide evidence on the effectiveness and real-world implementation of an integrated Ayurveda-based intervention within an existing national anemia program, informing its integration and scale-up for adolescent anemia in India and comparable settings. Clinical Trial: Clinical Trials Registry–India CTRI/2024/10/075128; URL https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTEzMzk0&Enc=&userName=CTRI/2024/10/075128
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