• intent@hq.icmr.org.in

# Ongoing Clinical Trial Participating Sites
1 Efficacy and safety of Punarnavadi Mandura alone and in combination with Drakshavaleha compared to
iron folic acid in the treatment of moderate iron deficiency anaemia among non-pregnant women of
reproductive age group: a community-based three arm multi-centre randomized controlled trial.
2 A Phase-I, Open Label, Dose Escalation, Dose Expansion, Multicenter, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR107 in Patients with Relapsed Advanced Malignancies (SHAKTI-1) 2 Phase-I sites + 26 other sites
CTRI/2023/05/052954
3 A Multicentre, Open-Label, Single-Arm, Two- Cohort, Phase 3, Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Eliglustat Sublingual Film in Patients with Gaucher Disease Type 1 6 Sites
CTRI/2024/08/072953
4 A Phase-I Double Blind, Randomized, Placebo Controlled, Parallel, Multicentre, Proof-of-concept Study To Evaluate The Efficacy And Safety Of Desidustat Oral Tablet For Treatment Of Sickle Cell Disease 5 Sites
CTRI/2024/06/068363

# Critical Trial Status Sites
1 A Phase-I, Proof-of-Concept, Placebo Controlled, Randomised Trial to Investigate the Efficacy and Safery of Oxfendazole as a Macrofilaricidal Drug in Adults Harbouring Lymphatic Filarial Worms. Approved by DCGI, to be initiated in May 2025,
2 Efficacy and Safety of Ayurvedic package of Interventions vs Allopathic package of interventions in treatment of early knee osteoarthritis, a Phase-III randomized controlled trial Preparatory Phase
3 Safety and efficacy of probiotic interventions in reducing mortality, severe infection and morbidity in preterm and SGA infants. Preparatory Phase
4 Efficacy and safety of Bedaquiline in combination with MDT for the treatment of Multibacillary Leprosy Preparatory Phase
5 KFD Vaccine Preparatory Phase
1.PGIMER, Chandigarh,
2. ACTREC, Navi Mumbai from the Phase-I network and 26 other sites
6 Mynflu001 (a novel quadrivalent, recombinant protein subunit vaccine for seasonal influenza) Preparatory Phase 1. SRM Medical College Hospital and Research Centre, Chennai,
2. KEM Medical College and Hospital, Mumbai,
7 Zika virus vaccine- Recombinant live attenuated Preparatory Phase
SRM Medical College Hospital and Research Centre, Chennai (proposed)

# Name of Product Status Sites
1 High-Performance Optical Spectroscopy (HPOS Technology)- Point-of-Care Diagnostic Test for Sickle Cell Anemia Validation Study Ongoing 1. NIIH, Mumbai
2 BP Instrument - Digital Blood pressure measurement using Korotkoff sounds and oscillatory waveforms. Approved by PRC 1. Chettinad Hospital and Research Institute, Tamil Nadu
2. RIMS, Ranchi
3. AIIMS, Nagpur
3 Kit for collection of Dried Blood Spot Samples for the purpose of Therapeutic Drug Monitoring (TDM) of first line AntiTuberculosis Drug Levels (ATT). Preparatory Phase (Protocol Developed) 1. AIIMS- Delhi
2. JIPMER, Puducherry
4 CanScan - a portable, rapid breath analyser test for in-vitro detection of Volatile Organic Compounds (VOCs) associated with breast cancer Preparatory Phase 1. AIIMS, Rishikesh
2. Kasturba Medical College, Manipal
5 SindiColpo - AI based early identification of precervical lesions Preparatory Phase (Protocol Developed) 1. Dr. Moopen's Medical College, Wayanad
2. Amrita Institute of Medical Sciences, Kochi
6 AI based PAP smear - AI-enabled digital pathology system serves as a decision support tool in cervical cancer screening. Preparatory Phase (Protocol Developed) 1. AIIMS, Jodhpur
2. SCB Medical College & Hospital, Cuttack
7 Smart stetho (AISteth) - for screening and diagnostic decision support in cardiovascular conditions Preparatory Phase (Protocol Developed) 1. Dr. Moopen's Medical College, Wayanad
2. SRM Medical College Hospital & Research Centre, Chennai
8 Can Assist - CanAssist Breast (CAB) test is an immunohistochemistry (IHC)-based in vitro diagnostic test performed on invasive breast tumor tissue. Preparatory Phase 1. MGMCRI, Puducherry
2. Dayanand Medical College and Hospital, Ludhiana