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CTRI Number  CTRI/2024/11/076299 [Registered on: 05/11/2024] Trial Registered Prospectively
Last Modified On: 08/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To see the safety and effectiveness Nuvastatic® 300 mg in reducing chemotherapy induced fatigue in patients with metastatic triple negative breast cancer receiving standard chemotherapy 
Scientific Title of Study   A randomized double blind placebo controlled multicenter phase III study to evaluate the efficacy and safety of Nuvastatic® 300 mg in reducing chemotherapy induced fatigue in patients with metastatic triple negative breast cancer receiving standard chemotherapy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
EBCT003 V.1.0 dated 12/SEP/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms. Aman Ahlawat 
Designation  Director innayat medical 
Affiliation  Innayat Medical  
Address  Clinical Research Department Room no 03 ground floor Mayfield garden B 16 ground sector 50 gurugram haryana

Gurgaon
HARYANA
122002
India 
Phone  9870406867  
Fax  -  
Email  amanahlawat1918@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Chandu Gangadhar Devanpally 
Designation  Founder & Managing Director 
Affiliation  Ardent Clinical Research Services 
Address  Room No 01 Office no 302 303 Level-3 nyati unitree pune nagar road
Pune
Pune
MAHARASHTRA
411006
India 
Phone  07507779256  
Fax  -  
Email  cdevanpally@ardent-cro.com  
 
Details of Contact Person
Public Query  
Name  Mr Chandu Gangadhar Devanpally 
Designation  Founder & Managing Director 
Affiliation  Ardent Clinical Research Services 
Address  Room No 01 Office no 302 303 Level-3 nyati unitree pune nagar road
Pune
Pune
MAHARASHTRA
411006
India 
Phone  07507779256  
Fax  -  
Email  cdevanpally@ardent-cro.com  
 
Source of Monetary or Material Support  
Natureceuticals Sdn Bhd A1-1 A1-2 & A1-3 Lot 5 Kedah Halal Park Persiaran 2/1 Kawasan Perindustrian 08000 Sungai Petani Kedah Malaysia 
 
Primary Sponsor  
Name  Natureceuticals Sdn Bhd 
Address  A1-1 A1-2 & A1-3 Lot 5 Kedah Halal Park Persiaran 2/1 Kawasan Perindustrian 08000 Sungai Petani Kedah Malaysia 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shriram Kane  Arihant Multispeciality Hospital  Oncology department first floor 4 35 36 Rambagh Road Near Baidyanath Square Opposite Tata Heights Nagpur
Nagpur
MAHARASHTRA 		 9823012851
-
shriramkane@gmail.com 
Dr Vikram RGajare   Dr.Vikram R Gajare  Minaai Multispeciality Hospital 1st Floor Ganesh Tower Behind Vijay Punjab Hotel Kharigaon Naka B P Road Bhayander Thane 401105
Thane
MAHARASHTRA 		 9833527266
-
drvikram.gajare@gmail.com 
Dr K Velavan  Erode Cancer centre  Clnical research department first floor Erode Cancer Care Centre 1 393 Velavan Nagar Perundurai road Thindal Erode 638012
Erode
TAMIL NADU 		 9842334222
-
kvels@rediffmail.com 
Dr Govindaraj Ganesan  Harshamitra super speciality Cancer and Research Centre  Oncology Department Ground Floor Room No 2 Surgical Oncology division Harshamitra Super Speciality Cancer Care And Research Institute No 101/4A Mathur Panchayat Road Madurai Highway Nagamangalam Trichy 620012
Madurai
TAMIL NADU 		 9844685166
-
harshamitraprinicpleinvestigat@gmail.com 
Dr Chaudhari Nitin Laxman  Jeevanjyoti Cancer Hospital  Ground floor OPD No 01 Jeevanjyoti Cancer Hospital Plot No 47 Vivkanand Nagar Jilha Peth Near Gulabrao Deokar Pharmacy College Jalgaon 425001 Maharashtra Jalgaon
Jalgaon
MAHARASHTRA 		 8380007270
-
drnlchaudhari@gmail.com 
Dr Vikas L  K R Hospital  Oncology department first floor K R Hospital Irwin Road Mysuru Karnataka 570001
Mysore
KARNATAKA 		 9663099774
-
Vikilaxman@gmail.com 
Dr Alpa Chandulal Vora  Kaivalya Hospital and Research Centre Thane  Kevalya Hospital And Research Centre Siddhi Apartments near Ghodbunder Road Vijay Garden rd Thane west
Thane
MAHARASHTRA 		 9820091853
-
alpamodi@gmail.com 
Dr Saurabh Prasad  KIMS Kingsway Hospitals  OPD no 01 fifth floor 44 kingway road Near Kasturchand Park Nagpur Maharashtra 440001 Nagpur MAHARASHTRA
Nagpur
MAHARASHTRA 		 07058041596
-
khclinicalresearch@gmail.com 
Dr Bella Ravi  Omega Hospital  Research Department ground floor Room number 5 Omega Hospital Chinna Gadhili Hanumanthavaka Visakhapatnam Andhra Pradesh 530040
Visakhapatnam
ANDHRA PRADESH 		 9849123256
-
rbellalaravishankar@gmail.com,  
Dr Phole Madhav Bhaurao  Renukai Critical care and Multispeciality Hospital  Renukai Critical care and Multispecility Hospital Behind LIC Office Bafna Road Nanded 431602 Maharashtra India
Nanded
MAHARASHTRA 		 9405377206
-
drphole121@gmail.com 
Dr Nikhil Shirsi  Sangvi Research Multispeciality Hospital  SANGVI MULTISPECIALITY HOSPITAL S NO 71/1/2/189 C S 2387 KRUSHNA CHOWK KRISHNA NAGAR NEW SANGVI PUNE Pune Maharashtra 411027 India
Pune
MAHARASHTRA 		 7835826155
-
drshirsi.sangvihospital@gmail.com 
Dr Abhishek Mahaveer Patil  Sanjeevini Hospital   Sanjeevini Speciality Hospital and Heart Care Center Shirur park main road OPD No 03 Ground floor Department of Critical care medicine and Oncology Sanjeevini Speciality hospital and Heart Care Center Vidya nagar Hubli Karnataka 580031
Belgaum
KARNATAKA 		 99161 32321
-
abhishekpatil1061@gmail.com 
Dr Ajay C  Sanjeevini Speciality Hospital  Hubli Super Specialty Hospital C/o Shivaleela Foundation Behind Hans Hotel Rambhapuri Kalyana Mantap Road Kalyan Nagar Vidya Nagar Hubballi Karnataka 580031
Belgaum
KARNATAKA 		 8220220884
-
ajaychandranaath@gmail.com 
Dr shreeniwas Raut  Silver Birch Multispeciality Hospital  OPD no 3 basement Plot no 4 sr no 6/1A/9/20/10/11 Near Sawatamali mandir Narhe Dhayari road Pune Maharashtra 411041
Pune
MAHARASHTRA 		 9099407702
-
shreeniwasraut74@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
ETHICS COMMITTEE RAJA NURSING HOME KANPUR  Approved 
Ethics committee sanjeevini speciality Hospital  Approved 
IEC-SANGVI MULTISPECIALITY HOSPITAL  Approved 
Institutional Ethics Committee Arihant Multispeciality Hospital  Approved 
Institutional Ethics Committee Erode Cancer Centre Erode  Approved 
Institutional Ethics Committee Harshamitra Superspeciality Cancer Centre  Approved 
Institutional Ethics Committee hira mongi Navneet Hospital  Approved 
Institutional Ethics Committee Mysore medical college & research Institue  Approved 
Institutional Shrikrishna Hospital  Approved 
INstutional ethics committee omega hospital  Approved 
Kingsway Hospitals Ethics Committee   Approved 
Mangalmurti institutional ethics committee  Approved 
Renukai Institutional ethics committee  Approved 
Samarth Hospital Institutional Ethics Committee  Approved 
Sanjeevini Speciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nuvastatic® 300 mg capsules containing 300 mg standardized extract of Orthosiphon stamineus  Nuvastatic® 300mg dose to be consumed after meal 3 capsules × 3 times a day Total 9 capsules a day to be consumed upto 3 weeks 
Comparator Agent  Placebo capsules (containing microcrystalline cellulose)   Placebo is to be consumed after meal 3 capsules × 3 times a day Total 9 capsules a day to be consumed upto 3 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Patients greater than equal to 18 years and less than equal to 65 of age who are willing to voluntarily provide consent for participation in the study
2 Patients with confirmed triple negative metastatic breast cancer planned or scheduled to receive standard chemotherapy treatment for at least 6 cycles respectively
3 Patient must have a confirmed diagnosis of triple negative metastatic breast cancer as per standard guideline
4 Patient must have at least one tumour lesion with ≥ 1cm in one dimension that is radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI)
5 Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening
6 Life expectancy ≥ 6 months as per Investigators judgment
7 The patient has stable hemoglobin (≥ 9 g/dL) throughout the screening
8 Patients with co-morbidities or medical conditions including Type 2 DM, hypertension and are deem stable by the investigator can be included in the study
9 At screening patient with stable fatigue has a newly developed fatigue OR worsening of fatigue scoring as assessed by BFI should be included
 
 
ExclusionCriteria 
Details  1 Patients who have any untreated reversible medical condition which may cause fatigue (e g major metabolic or electrolyte disturbance active infection endocrine abnormalities) as per the Investigators clinical judgment
2 Patients with an inability to understand local language(s) for scales used for evaluations i e VAFS BFI AND SF-36
3 Patients who have received concurrent stimulant medication (e g dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with study drug
4 Patients with any delay in chemotherapy treatment such that the screening period extends beyond 28 days
5 Patients with known central nervous system (CNS) involvement by metastatic cancer
6 Patients with any serious, uncontrolled nonmalignant medical or psychiatric disorder or any other medical condition which in the opinion of the Investigator may affect the patients safety or study participation and conduct
7 Female patients who are pregnant or breast feeding
8 Patients with known hepatitis C virus hepatitis B virus HIV infection
9 Patients who have nausea and vomiting or any gastrointestinal disorder that is severe enough to interfere with study drug absorption in the opinion of the Investigator
10 Patients with uncontrolled pain who in the opinion of the Investigator are not eligible for the study
11 Patients with known hypersensitivity or intolerance of rosmarinic acid caffeic acid and other related phenolic compounds as well as excipients in the Nuvastatic® 300mg or Placebo treatment
12 Patients with planned therapy or treatment with another investigational agent
13 Previous exposure to any investigational agent within 4 weeks prior to screening, or planned administration of an Investigational agent other than as specified by this protocol during the study period
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1 Improvement in chemotherapy induced fatigue as assessed by 1 BFI
2 Brief Fatigue Inventory
3 Visual analogue scale fatigue SF-36
4 Short form-36 Quality of Life
 		 Baseline to visit 6 and after 3 months of EOT
 
 
Secondary Outcome  
Outcome  TimePoints 
1 Improvement in RECIST 1.1 score
2 Incidence of adverse events (AEs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 		 Baseline to visit 6 and after 3 months of EOT 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  

This is a randomized, double-blind, placebo-controlled, parallel-group assignment, comparative clinical study of Nuvastatic® 300mg in patients with newly diagnosed, chemotherapy naïve, non-respectable triple negative metastatic breast cancer receiving standard chemotherapy. 1 week prior to initiation of first chemotherapy, patients will be administered with test product in ascending dose.

Patients with triple negative metastatic breast cancer who are receiving or are scheduled to receive standard treatment including Doxorubicin and Cyclophosphamide, FOLFOX/FOLFIRI or AT, CAF, FC etc. treatment respectively will be eligible for enrolment in the study. Patients should be scheduled to receive at least 4 chemotherapy cycles 3-weekly (21 days OR 14 days), as per the Investigator’s judgment and standard of care. Patients meeting the eligibility criteria will be consented and screened for baseline fatigue scores using BFI prior to commencement of their chemotherapy Cycle 1. The screening period will last up to 28 days prior to Cycle 1. Prior to enrolment in the study on Day 1 (Cycle 1), patients will be re-evaluated for inclusion criteria and change in fatigue severity as per BFI. Patients should still be considered for study enrolment if the fatigue severity as per the BFI has not increased by at least one score from the initial assessment (before Cycle 1) during the screening.

 Those with stable fatigue scores, newly developed fatigue or worsening of their fatigue score will be eligible for enrolment in the study and will be randomized to receive   Nuvastatic® 300 mg or Placebo in a 1:1 ratio. Dosing and duration for standard chemotherapy will be at the Investigator discretion and standard of care of study centre. A 3-   weekly (21 days or 14 days) cycle is assumed but can vary based on the patients. This is a randomized, double-blind, placebo-controlled, parallel-group assignment,   comparative clinical study of Nuvastatic® 300mg in patients with newly diagnosed, chemotherapy naïve, non-resectable triple negative metastatic breast cancer receiving     standard chemotherapy. 1 week prior to initiation of first chemotherapy, patients will be administered with test product in ascending dose.

Patients with triple negative metastatic breast cancer who are receiving or are scheduled to receive standard treatment including Doxorubicin and Cyclophosphamide, FOLFOX/FOLFIRI or AT, CAF, FC etc. treatment respectively will be eligible for enrolment in the study. Patients should be scheduled to receive at least 4 chemotherapy cycles 3-weekly (21 days OR 14 days), as per the Investigator’s judgment and standard of care. Patients meeting the eligibility criteria will be consented and screened for baseline fatigue scores using BFI prior to commencement of their chemotherapy Cycle 1. The screening period will last up to 28 days prior to Cycle 1. Prior to enrolment in the study on Day 1 (Cycle 1), patients will be re-evaluated for inclusion criteria and change in fatigue severity as per BFI. Patients should still be considered for study enrolment if the fatigue severity as per the BFI has not increased by at least one score from the initial assessment (before Cycle 1) during the screening.

 
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