CTRI

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CTRI Number

CTRI/2025/05/087937 [Registered on: 30/05/2025] Trial Registered Prospectively

Last Modified On:

11/03/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Nutraceutical

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

to check the Effect and Safety of Nuvastatic™ in Reducing Cancer Related Fatigue in Colon Cancer Patients

Scientific Title of Study

Phase III Randomized Double Blind Placebo Controlled Study to Evaluate the Efficacy and Safety of Nuvastatic™ in Reducing Cancer Related Fatigue in Colon Cancer Patients Undergoing First Line Chemotherapy

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NUVA-CC-III-2025 1.0 Dated 07/MAY/2025	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 3rd floor office no 302 303 nyati unitree building yerwada Pune MAHARASHTRA 411006 India
Phone	09545817447
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 3rd floor office no 302 303 nyati unitree building yerwada MAHARASHTRA 411006 India
Phone	09545817447
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 3rd floor office no 302 303 nyati unitree building yerwada MAHARASHTRA 411006 India
Phone	09545817447
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	Natureceuticals Sdn Bhd 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
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 9
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ravindra Nadhana	Asian cancer hospital	Department of Medical Oncologist Managing Director Asian cancer hospital Old Day and Night complex Day and night junction Srikakulam 532001 A P India Srikakulam ANDHRA PRADESH Srikakulam ANDHRA PRADESH	9948741133 - bioexperts21@gmail.com
Dr EzhilarasiR	CHALMEDA ANANDRAO INSTITUTE OF MEDICAL SCIENCE	Chalmeda Anand Rao Institute of Medical Science Cancer Hospital and Research Institute H no 10 100 by 1 Bommakal Karimnagar Telangana 505001 Karimnagar TELANGANA	9440073399 - ezhil2002@yahoo.com
Dr Abhinnadan Mahavir Hanji	Hanji Cancer Centre	Ground Floor Consultation Room 1 Hanji Hospital Cancer Care 135 Mangalwar Peth Tilakwadi Belagavi Karnataka Belgaum KARNATAKA	8747004004 - drabhinandanhanji@gmail.com
Dr Govindaraj Ganesan	Harshmitra super speciality cancer & research Centre	Oncology Department ground floor room no 2 surgical oncology division 101/4A mathur panchayat road madurai highway nagamangalam trichy Madurai TAMIL NADU	9844685166 - harshamitraprincipleinvestigat@gmail.com
Dr Asma Pathan	Indrayani Hospital and Cancer Institute	department of oncology 1st floor Alandi Chakan Road Alandi Devachi Pune 412105 Pune MAHARASHTRA	8007167716 - asmapathan124@gmail.com
Dr Vikas L	K R hospital Mysore medical college and research Institute	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 mysore 570001 Mysore KARNATAKA Bangalore KARNATAKA	9663099774 - Vikilaxman@gmail.com
Dr Dattatraya Andure	Onco Life Cancer Centre	GOnco Life Cancer Centre Ground Floor OPD No 2 Survey no 252 A/P Shendre Opp Abhaysinhraje Bhonsle Institute Of Technology Tal and District Satara Maharashtra 415519 Satara MAHARASHTRA Satara MAHARASHTRA	7276556028 - drandureolcccr@gmail.com
Dr Jyoti Ashok Mehta	OncoLife Cancer Centre	Onco-Life Cancer Centre Pvt Ltd Talegaon Ground Floor OPD No 3 Talegaon General Hospital Talegaon Chakan Road Yashwant Nagar Talegaon Dabhade Tal Maval Pune MAHARASHTRA Pune MAHARASHTRA	95910 97197 - drjyotimehtacr@yahoo.com
Dr Abhishek Mahaveer Patil	Sanjeevini Speciality Hospital and Heart Care Center	Sanjeevini Speciality Hospital and Heart Care Center Shirur park main road OPD Number 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

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 9
Name of Committee	Approval Status
CAIMS CANCER HOSPITAL AND RESEARCH INSTITUTE CAIMS CANCER HOSPITAL AND RESEARCH INSTITUTE	Approved
Ethics committee sanjeevini speciality Hospital	Approved
Institutional Ethics Committee Govt Medical College	Approved
Institutional Ethics Committee harshmitra oncology Pvt Ltd	Approved
Institutional Ethics Committee Mysore Medical College and Research Institute	Approved
Institutional Ethics Committee Onco Life Cancer Centre	Approved
Institutional Ethics Committee Onco Life Cancer Satara	Approved
Lakeview Ethics Committee	Approved
Narsimha saraswati Medical foundation Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: C189\|\|Malignant neoplasm of colon, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nuvastatic™ 1000mg Sachet	Nuvastatic™ 1000mg Sachets to be consumed after meal 1 Sachet 3 times a day to be consumed for 3 cycles(Eah cycle 21 days) to be taken with water as suggested by Principal investigator
Comparator Agent	Placebo of Nuvastatic™ 1000mg Sachet	Nuvastatic™ 1000mg Sachets to be consumed after meal 3 times a day 1 Sachet to be taken with water for 3 cycles (Each cycle 21 days)as suggested by Principal investigator

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1 Male and female Patients who are greater than or equal to 18 and ;less than or equal to 65 years of age who are willing to voluntarily provide consent for participation in the study 2 Patients with colon cancer planned or scheduled to receive standard chemotherapy treatment for at least 3 cycles respectively 3 Patients must have a confirmed diagnosis of colon cancer as per standard guideline 4 Eastern Cooperative Oncology Group performance status of 0 to 2 at Screening 5 The patient has stable haemoglobin greater than or equal to 9 g per dL throughout the screening 6 Life expectancy greater than or equal 6 months as per Investigators judgment 7 Patients with comorbidities or medical conditions including Type 2 DM hypertension and are deemed stable by the investigator can be included in the study 8 At screening patients with stable fatigue has a newly developed fatigue OR worsening of fatigue scoring as assessed by BFI should be included 9 Starting firstline chemo

ExclusionCriteria

Details

1 Patients who have any untreated reversible medical condition which may cause fatigue example metabolic disturbance infection endocrine abnormalities as per the Investigators clinical judgment
2 Patients who have stage IV Disease
3 Patients who have received concurrent stimulant medication example dextroamphetamine or methylphenidate during the screening period or any medication which may interfere with study drug
4 Prior metastatic chemo targeted immunotherapy severe comorbidities
5 Female patients who are pregnant or breast feeding
6 Patients with known hepatitis C virus hepatitis B virus HIV infection
7 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
8 Patients with uncontrolled pain who in the opinion of the Investigator are not eligible for the study
9 Patients with planned therapy or treatment with another investigational agent
10 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

On-site computer system

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
1 Change in BFI score	1 from screening to end of treatment for total( 3 cycles) 9 weeks of treatment period

Secondary Outcome

Outcome	TimePoints
1 Change in serum CEA & CA125 levels 2 Fatigues SF-36 questionnaire 3 Change in the laboratory Parameter 4 Change in Global Health Status/QoL score as measured by the EORTC QLQ-C30 5 Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events version 5	1 to 4- screening to end of treatment for total( 3 cycles) 9 weeks of treatment period 5 Screening to End of the study total 12 weeks of period

Target Sample Size

Total Sample Size="180"
Sample Size from India="180"
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)

10/06/2025

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="0"
Months="7"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

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

This is a Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nuvastatic™ in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy

TEST: Nuvastatic™ 1000mg Sachet containing effervescent powder proprietary standardized extract of Orthosiphon stamineus (C5OSESW5050ESA) manufactured by Natureceuticals Sdn Bhd, Malaysia.

PLACEBO: Placebo of Nuvastatic™ 1000mg Sachet to be provided by Natureceuticals Sdn. Bhd., Malaysia.

Dosage and Administration:

Nuvastatic™ 1000mg Sachet/Placebo is to be consumed after meal 3 times a day. 1 Sachet X 3 times a day to be consumed for 3 cycles.

To be taken with water as suggested by Principal investigator.

CHEMOTHERAPY:

Colon cancer arm:

The chemotherapy to be used during this study is as per the standard of care of study center, e.g. given for treatment cycles of 3 weeks (21 days) each. Chemotherapy is required to be procured by the patient as part of their routine treatment plan, irrespective of participation in this study. The dose and administration of standard chemotherapy will be managed as per the Investigator’s clinical judgment and in line with the treatment plan for the patient.

The duration of participation for the patient will be approximately 3 months.

The total duration of the study including recruitment, will be approximately 4 to 6 months.