A Phase 3 interventional study of Nuvastatic™ and Placebo in Fatigue and Colon Cancer, sponsored by Natureceuticals Sdn Bhd. Recruiting at 6 sites in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Natureceuticals Sdn Bhd · Phase 3, Interventional, and Supportive care
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Among 12 studies in Fatigue with a site in India — 3 open to participants now, 3 under way, 3 of them phase 3. Fatigue · India.
Among the 12 studies in Fatigue with a site in India, this one is the 4th largest by planned enrollment of the 11 interventional ones that give a count, is one of 4 that started in 2025, is one of 4 in phase 3, and was the 8th registered.
2,231 studies on the registry are indexed under Fatigue; 427 are open to participants now.
Browse Fatigue studies →3 of the 12 studies in Fatigue with a site in India are open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in India, United States, Australia and 17 more countries
Ages 18+
Pfizer · Sites in India, United States, Australia and 18 more countries
Ages 18+
A study can be open while its sites in India have not opened yet or have stopped. Only those recruiting at a site in India →
Of the 239 Fatigue studies recruiting now, 111 (46%) set no upper age limit and 98 (41%) stop at 75 or younger; 23 take children under 18; 73 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 2 · Phase 3 5
First in 2008; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 180 is above the median of 54 across 1,759 interventional studies indexed under Fatigue.
Median enrollment 128 across the 11 interventional studies, 3 across the 1 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 12 have an industry lead sponsor. The 10 most frequent:
Natureceuticals Sdn Bhd is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Natureceuticals Sdn Bhd has 2 studies filed under Fatigue — fewer than ten, so there is no comparison to draw.
1 of the studies in Fatigue with a site in India that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07669519Phase 3Natureceuticals Sdn BhdEvaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy | 2027-03-31 |
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Among the 12 studies in Fatigue with a site in India, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to evaluate whether Nuvastatic can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy.
The main questions it aims to answer are:
Does Nuvastatic significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic safe and well tolerated in this patient population?
Researchers will compare Nuvastatic vs placebo to see if Nuvastatic improves fatigue scores and maintains an acceptable safety profile.
Participants will:
Receive Nuvastatic or placebo sachets (3 times per day) for 3 cycles of 20 days each (total \~60 treatment days).
Continue their standard first-line chemotherapy regimen. Provide blood samples for biomarkers (CEA, CA-125) at Screening and End of Treatment.
Complete patient diaries and fatigue assessments as per protocol.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nuvastatic™ 1000mg Sachet
Drug: Nuvastatic™
Placebo 1000mg Sachet
Drug: Placebo
1000mg Sachet, (1 sachet X 3 times a day)
1000mg sachet, (1 sachet X 3 times a day)
Changes in cancer-related fatigue in colon cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
intra-individual changes in the Brief Fatigue Inventory (BFI)
Time frame: from screening up to 12 weeks
Changes in cancer-related fatigue in colon cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Fatigue scale and Visual Analogue Fatigue Scale (VAFS)
Time frame: From Screening up to 12 weeks
Overall QoL and functional improvement
The secondary outcome measure was the overall QoL improvement using the medical outcome scale Short Form-36 (SF-36). ECOG scores were compared at baseline and at end of the study.
Time frame: at baseline and at end of the study at 12 weeks
Started Aug 2025 (actual). Primary completion is estimated for Mar 2027, 19 months after the start.
Of 27 phase 3 interventional studies under Fatigue, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 61. This study's planned 19 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.