A Multicentre Clinical Study Comparing Two Nutrient Based Therapies (Glutathione 50 mg Plus Glutamate 500 mg Plus Glutamine 500 mg Plus L Arginine 3 gm vs L Arginine 3 gm Plus Proanthocyanidin 75 mg) for the Management of Intrauterine Growth Restriction (IUGR)

A randomised double arm comparative open label multicentre clinical study to evaluate the safety and efficacy of Glutathione 50 mg plus Glutamate 500 mg plus Glutamine 500 mg plus L Arginine 3 gm vs L Arginine 3 gm plus Proanthocyanidin 75 mg in the management of Intrauterine Growth Restriction (IUGR) - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/095408

Enrollment

Registered

2025-09-25

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O365- Maternal care for known or suspected poor fetal growth

Interventions

Intervention1: Glutathione 50 mg + Glutamate 500 mg + Glutamine 500 mg + L-Arginine 3 gm: Medicine Name:Glutathione 50 mg + Glutamate 500 mg + Glutamine 500 mg + L-Arginine 3 gm Route: Oral, Dosage Fo

Eligibility

Inclusion criteria

Inclusion criteria: Female of childbearing age 18 45 years (inclusive) Singleton viable pregnancy with gestational age 32 37 weeks Ultrasound-confirmed IUGR, defined as Estimated Fetal Weight (EFW),10th percentile for gestational age Hemodynamically stable and not requiring inpatient care at screening Willing and able to provide written informed consent Willing to comply with study procedures, visit schedule, and follow-up

Exclusion criteria

Exclusion criteria: Multifetal gestation (twins or higher) Major fetal structural anomaly or known chromosomal abnormality Severe pre-eclampsia/eclampsia or uncontrolled hypertension (systolic greater than or equal to 160 mmHg or diastolic greater than or equal to 110 mmHg) Severe maternal systemic disease is likely to affect fetal growth or outcome (e.g., uncontrolled Type 1 diabetes, severe cardiac disease, active systemic lupus with nephritis). Placental conditions likely responsible for growth restriction are not amenable to medical therapy (e.g., placenta previa with major bleeding, confirmed placental abruption). Known rhesus isoimmunization with significant fetal anaemia or hydrops. Evidence of active intrauterine infection (e.g., CMV, Toxoplasma) suspected to cause IUGR. Any condition placing the mother or fetus at unacceptable risk as judged by the investigator.

Design outcomes

Primary

Measure	Time frame
To compare the change in fetal biometric parameters (estimated fetal weight, abdominal circumference) between the two treatment arms.Timepoint: V1 Screening/ Baseline (Day 0), V2 Randomisation (Day 1), V3 1st Follow-up (Day 7 1), V4 Last Follow-up (Day 15 1)	—

Secondary

Measure	Time frame
To compare birth weight and gestational age at delivery To assess maternal safety and tolerability To evaluate maternal quality of life using validated pregnancy health questionnaires Timepoint: V1 Screening/ Baseline (Day 0), V2 Randomisation (Day 1), V3 1st Follow-up (Day 7 1), V4 Last Follow-up (Day 15 1)	—

Countries

India

Contacts

Public ContactDrSudeep Kumar Patra

Indivirtus Global CRO Pvt. Ltd.

director.research@indivirtus.com9861252518

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026