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Evaluation of Clinical Efficacy and Safety of Nuvastatic in Cancer Asthenia

NCT04546607 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-09-16

No results posted yet for this study

Summary

Nuvastatic TM (C5OSEW5050ESA)is a special formulation derived from the standardized extract of O. stamineus leaves developed by Natureceuticals Sdn. Bhd. The extract is prepared from meticulous extraction using sophisticated phytochemical techniques, where the particular phytopharmaceuticals (active ingredients) are being concentrated to achieve the desired therapeutic efficacy. In the proposed human study, it is anticipated that administering dietary supplement of standardized O. stamineus rosmarinic acid-enriched Nuvastatic TM (C5OSEW5050ESA) 1000 mg (3 times a day), can ameliorate fatigue in cancer patients. This is based on scientific studies that support its ability in reducing oxidative damage and restore mitochondrial and other cellular functions involved in cellular energy production. It is further hypothesized that the anti-inflammatory, antinociceptive anti-oxidant, and neuroprotective properties of the active compound rosmarinic acid may also potentially assist in pain control, sleep loss, lethargy and other symptoms strongly associated with cancer-related fatigue.

Conditions

Interventions

OTHER

Nuvastatic TM (C5OSEW5050ESA) 1000 mg

Nuvastatic TM is a patented polymolecular botanical medicine made from Lanctos 75TM which is a proprietary high potency herbal standardized extract.

Sponsors & Collaborators

  • Natureceuticals Sdn Bhd

    lead INDUSTRY

Principal Investigators

  • Ghanashyam Biswas, PHD · Sparsh Hospitals & Critical Care Pvt. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-02
Primary Completion
2019-10-28
Completion
2019-10-31

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04546607 on ClinicalTrials.gov