FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/095408 [Registered on: 25/09/2025] Trial Registered Prospectively
Last Modified On: 25/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   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) 
Scientific Title of Study   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) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrMadhusmita Nayak 
Designation  Advanced Laparoscopic Surgery Infertility Specialist 
Affiliation  Aurashree Multispeciality Clinic 
Address  Aurashree Multispeciality Clinic, Near Subhadra Apartments, Nandan Vihar, Patia, Bhubaneswar, Odisha-751024, India

Khordha
ORISSA
751024
India 
Phone  8891383134  
Fax    
Email  drmadhusmitaobg@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrSaiprasanna Behera 
Designation  Director Research 
Affiliation  Indivirtus Global CRO Pvt. Ltd. 
Address  Indivirtus Global CRO Pvt. Ltd. 521-522 Top Floor Taj Plaza TDI City Sector-118 Mohali Punjab India 160059

Chandigarh
CHANDIGARH
160059
India 
Phone  9861252518  
Fax    
Email  director.research@indivirtus.com   
 
Details of Contact Person
Public Query  
Name  DrSudeep Kumar Patra  
Designation  Chief Operating Officer 
Affiliation  Indivirtus Global CRO Pvt. Ltd.  
Address  Indivirtus Global CRO Pvt. Ltd. 521-522 Top Floor Taj Plaza TDI City Sector-118 Mohali Punjab India 160059

Chandigarh
CHANDIGARH
160059
India 
Phone  9861268508  
Fax    
Email  sudeep.coo@indivirtus.com   
 
Source of Monetary or Material Support  
Aurashree Multispeciality Clinic, Near Subhadra Apartments, Nandan Vihar, Patia, Bhubaneswar, Odisha-751024, India 
 
Primary Sponsor  
Name  Indivirtus Global CRO Pvt. Ltd. 
Address  521-522 Top Floor Taj Plaza TDI City Sector-118 Mohali Punjab India 160059 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madhusmita Nayak  Aurashree Multispeciality Clinic  Near Subhadra Apartments, Nandan Vihar, Patia, Bhubaneswar, Odisha-751024, India
Khordha
ORISSA 		 8891383134

drmadhusmitaobg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ECUNCE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O365||Maternal care for known or suspected poor fetal growth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 Form: Granules Dose:5g, Frequency: BID, Time - Morning and Evening after food Duration: 15 Days 
Comparator Agent  L-Arginine 3 gm + Proanthocyanidin 75 mg  Medicine Name: L-Arginine 3 gm + Proanthocyanidin 75 mg Route: Oral, Dosage Form: Granules, Dose:5g, Frequency: BID, Time - Morning and Evening after food, Duration: 15 Days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  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 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the change in fetal biometric parameters (estimated fetal weight, abdominal circumference) between the two treatment arms.  V1 Screening/ Baseline (Day 0),
V2 Randomisation (Day 1),
V3 1st Follow-up (Day 7 ± 1),
V4 Last Follow-up (Day 15 ± 1) 
 
Secondary Outcome  
Outcome  TimePoints 
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
 		 V1 Screening/ Baseline (Day 0),
V2 Randomisation (Day 1),
V3 1st Follow-up (Day 7 ± 1),
V4 Last Follow-up (Day 15 ± 1) 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/10/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   IUGR is a major cause of perinatal morbidity and mortality, often linked to poor uteroplacental perfusion and oxidative stress. This study compares two regimens: the investigational formulation (Glutathione, Glutamate, Glutamine, L-Arginine) designed to antioxidant and metabolic support, versus a standard L-Arginine + Proanthocyanidin regimen. The trial will assess whether adding glutathione and amino acids offers superior short-term improvements in fetal biometry parameters in pregnancies with IUGR. 
Close