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Can a herbal sachet beat chemo fatigue? new trial aims to find out

NCT ID NCT07669519

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This Phase 3 study tests whether Nuvastatic, a herbal supplement taken as a powder sachet three times daily, can reduce cancer-related fatigue in adults with stage IV colon cancer who are starting chemotherapy. About 180 participants will receive either Nuvastatic or a placebo for 60 days while continuing their standard chemo. The main goal is to see if fatigue scores improve, with safety also closely monitored.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nuvastatic (herbal supplement sachet)
What this could lead to
If it works, this could offer a new option to reduce severe fatigue in colon cancer patients undergoing chemotherapy, improving their daily quality of life.
What could go wrong
This is a Phase 3 trial, but fatigue is subjective and hard to measure. The supplement may not outperform placebo, and its safety in this setting is still being confirmed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and female Patients who are ≥18 and ≤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 (ECOG) performance status of 0-2 at Screening. 5. The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening. 6. Life expectancy ≥ 6 months, as per Investigator's judgment 7. Patients with co-morbidities 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 first-line chemo Exclusion Criteria: 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 who have stage IV Disease 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. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Avicenna Hospital

    RECRUITING

    Lucknow, Uttar Pradesh, 226016, India

  • Department of Medical Oncology (In Charge - Oncology Unit)

    RECRUITING

    Srikakulam, Andhra Pradesh, 532001, India

  • Hanji Cancer Centre

    RECRUITING

    Belagavi, Karnataka, 590006, India

  • K.R. Hospital, Mysore Medical College & Research Institute

    RECRUITING

    Mysuru, Karnataka, 570001, India

  • Onco- Life Cancer

    RECRUITING

    Satara, Maharashtra, 415519, India

  • Onco-Life Cancer Centre, Pvt. Ltd

    RECRUITING

    Talegaon Dābhāde, Maharashtra, 410506, India

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