FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076297 [Registered on: 05/11/2024] Trial Registered Prospectively
Last Modified On: 28/03/2026
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 of Nuvastatic® 300mg capsule in fatigue who are receiving chemotherapy with patients suffering with colorectal cancer  
Scientific Title of Study   A randomized double blind placebo controlled parallel group comparative phase III study to evaluate the efficacy and safety of Nuvastatic® 300mg in reducing cancerinduced fatigue in patients with newly diagnosed chemotherapy naïve nonresectable metastatic colorectal cancer receiving standard chemotherapy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
EBCT004 V. 1.0 dated 19/SEP/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
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 MAHARASHTRA 411006 India
Pune
Pune
MAHARASHTRA
411006
India 
Phone  07507779256  
Fax  -  
Email  cdevanpally@ardent-cro.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 MAHARASHTRA 411006 India
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 MAHARASHTRA 411006 India
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 = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shriram Kane  Arihant Multispeciality Hospital  Seniour Oncologist and Hematologist first floor Arihant Multispeciality Hospital 34 35 36 Dahipura Opp Tata Heights Near Baidyanath Square
Nagpur
MAHARASHTRA 		 9823012851
-
shriramkane@gmail.com 
Dr Asma Pathan  Dr Asma Pathan  Indrayani Hospital and Cancer Institute Alandi Chakan Road Alandi Devachi Pune 412105
Pune
MAHARASHTRA 		 8007167716
-
asmapathan124@gmail.com 
Dr k velavan  Erode Cancer Care Centre  Department of Oncology Ground Floor Room No 24 SH-96 1/393 velavan nagar perundurai road Thindal TamilNadu 638012 Inida Erode TAMIL NADU
Erode
TAMIL NADU 		 9842334222
-
kvels@rediffmail.com 
Dr Govindaraj Ganesan  Harshamitra super speciality cancer centre and research institute  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 		 09844685166
-
harshamitraprinicpleinvestigat@gmail.com 
Dr Ajay C  Hubli Super Specialty 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 Sachin Anand Prakash  International Oncology Cancer Institute  Basement 2 Tower 2 International Oncology Cancer Tower 1 117 Q 40-A Sharda Nagar Kanpur
Kanpur Nagar
UTTAR PRADESH 		 9807546262
-
anandsachan1978@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 425001
Jalgaon
MAHARASHTRA 		 8380007270
-
drnlchaudhari@gmail.com 
Dr Vikas L  K R Hospital  Room No 01 Jayadeva Block KR Hospital 1st Floor Oncology Ward Opd No 23 Department of Oncology K R Hospital Mysore Medical College and Research Institute irwin road myore 570001 Mysore KARNATAKA
Mysore
KARNATAKA 		 9663099774
-
Vikilaxman@gmail.com 
Dr Bella Ravi shankar  Omega Hospital  Omega Hospital Room no 5 Plot no 4 health city arilova chinnagadhili hanumantha waka Visakhapatnam Andhra Pradesh 530040
Visakhapatnam
ANDHRA PRADESH 		 9849123256
-
drbellalaravishankar@gmail.com 
Dr Phole Madhav Bhaurao  Renukai Critical care & Multispecility Hospital  Ground floor OPD No 07 Renukai Critical care & Multispecility Hospital Behind LIC Office Bafna Road Nanded 431602
Nanded
MAHARASHTRA 		 9405377206
-
drphole121@gmail.com 
Dr Nikhil Mallinath Shirsi  Sangvi Research Multispeciality Hospital  Ground floor OPD no 3 and 4 Survey No 71/1/2/189 City Survey No 2387 Near Krishna Chowk Krishna Nagar New Sangvi 411027
Pune
MAHARASHTRA 		 7835826155
-
drshirsi.sangvihospital@gmail.com 
Dr Bhushan Manohar Nikam  Suryoday Cancer and Research Centre  Near Chintamani Ganesh Temple Malegaon Satana Road Dabhadi Tal Malegaon Dist Nashik 423201
Nashik
MAHARASHTRA 		 9403777963
-
drbhushanll@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
IEC-SANGVI MULTISPECIALITY HOSPITAL  Approved 
Institutional ethics commitee erode cancer centre  Approved 
Institutional ethics commitee omega hospital  Approved 
Institutional ethics commitee raja nursing home kanpur  Approved 
Institutional Ethics Committee Arihant multispeciality hospital  Approved 
Institutional Ethics Committee Harshamitra Superspeciality Cancer Centre  Approved 
Kingsway Hospitals Ethics Committee   Approved 
Mangalmurti institutional ethics committee  Approved 
Narsimha saraswati Medical foundation 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: K635||Polyp of colon,  
 
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 ≥ 18 years of age, who are willing to voluntarily provide consent for participation in the study.
2.Patients with metastatic colorectal cancer planned or scheduled to receive standard chemotherapy treatment for at least 6 cycles respectively.
3.Patient must have a confirmed diagnosis of metastatic colorectal 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 Investigator’s 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
 
 
ExclusionCriteria 
Details  1.Patients who have any untreated reversible medical condition which may cause fatigue (e.g. metabolic disturbance, infection, endocrine abnormalities) as per the Investigator’s clinical judgment.
2.Patients with an inability to understand local language(s) for scales used for evaluations i.e. EORTC QLQ-C30, 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, non-malignant medical or psychiatric disorder, or any other medical condition which in the opinion of the Investigator may affect the patient’s 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 
Improvement in tumor control  From baseline to End of treatment for total 126 days of duration 
 
Secondary Outcome  
Outcome  TimePoints 
1 Improvement in cancer-induced fatigue as assessed by BFI
2 Improvement in VAS-F Visual analogue scale
3 Change in Global Health Status/QoL score as measured by the EORTC QLQ-C30
4 Change in SF-36 Physical & Mental Health Composite Scores
5 Incidence of adverse events (AEs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
 		 1.Baseline to EOT
2.Baseline to EOT
3.Baseline to EOT
4.Baseline to EOT
5.Baseline to EOS
 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   13/11/2024 
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 Yet Recruiting 
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  

This is a randomized, double-blind, placebo-controlled, parallel-group assignment, comparative clinical study of Nuvastatic® in patients with newly diagnosed, chemotherapy naïve, non-resectable metastatic colorectal cancer receiving standard chemotherapy.

Patients with metastatic colorectal cancer who are receiving or are scheduled to receive standard treatment including 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. 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.

 Dosing and duration for standard chemotherapy will be at the Investigator’s 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 patient requirements and as deemed necessary by the Investigator. The patient will be evaluated for additional chemotherapy cycles as per the study treatment period.

After the completion of the treatment cycles, an end-of-treatment (EOT) assessment will be performed at the end of the last Cycle. A safety follow-up will be conducted 14 days after the EOT. .
 
Close