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Efficacy of VICRAD, the patented polyherbal formulation, as an adjuvant treatment during chemo and radiotherapy in head and neck cancer patients

Efficacy of VICRAD, the patented polyherbal formulation, as an adjuvant treatment during chemo and radiotherapy in head and neck cancer patients: A PHASE III Randomized Clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017414
Enrollment
70
Registered
2019-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C729- Malignant neoplasm of central nervous system, unspecified

Interventions

Intervention1: VICRAD Tablets: Amulya Herbs Pvt. Ltd. Haryana will supply the required tablets at no cost VICRAD is a mixture active extracts of known Medicinal Plants widely quoted in Ayurveda liter

Sponsors

Pravara Institute Of Medical Sciences Loni
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newly admitted with confirmed diagnosis, male and female patients suffering from oral cavity, oropharynx, larynx, hypopharynx undergoing chemo and radiotherapy treatment in the Department of Radiation Oncology of Pravara Rural Hospital, Loni Between the age group of 25 to 70 years Willing to participate in the study Willing to follow instructions Willing to give written consent as well as audiovisual consent

Exclusion criteria

Exclusion criteria: Pregnant females Lactating mothers Cancer patients suffering from other disease like liver, renal, cardiac disease, chronic obstructive pulmonary diseases, tuberculosis or any other co morbid condition Using potent inducers for CYP3A4 like rifampcin, phenytoin, barbiturates, carbamazepine or inhibitors like erythromycin, ketoconazole or cimetidine Patients with preexisting haematological disorders Patients with history of hypersensitivity to herbal products

Design outcomes

Primary

MeasureTime frame
Significantly increasing the haemoglobin and RBC counts in irrardiated mice � VICRAD was found to be immunostimulant and anti-inflammatory Histopathological studies revealed that VICRAD has protective role in preventing radiation induced damage in mice intestine and testis. � VICRAD also increased the activity of various antioxidant enzymes VICRAD , at molecular level found to protect DNA damage caused by irradiation Timepoint: All expected outcome will be tested after 51 days

Secondary

MeasureTime frame
VICRAD at molecular level found to protect DNA damage caused by irradiation � VICRAD protects bone marrow cellularirty and alpha esterase activity in the irradiated mice. Timepoint: 1 Year

Countries

India

Contacts

Public ContactDr Suresh Jangle

Pravara Institute Of Medical Sciences Loni

sureshjangle@gmail.com09823831044

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026