Estimation of Nitrate and Nitrite after administration of a herbal supplement Oxystorm (containing Red spinach-Amaranth extract) in 16 healthy human male subjects, under fasting condition.

Phase 4

Completed

• Registration Number: CTRI/2014/11/005192
• Lead Sponsor: Arjuna Natural Extracts Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-02-26
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

Subjects must fulfill all of the following criteria to be considered for inclusion into this study:

i.Subject who are able and ready to provide written informed consent.

ii.Subjects must be healthy human male subjects within 18-40 years of age (both inclusive), weighing at least 50 kg.

iii.Subjects should be having Body Mass Index (BMI) in the range 18.5-30.0 kg/m2.

iv.Subjects must be of normal health as determined by medical history and physical examination, ECG, chest X-ray (PA View) and laboratory tests performed within 21 days prior to the commencement of the study.

v.Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.

vi.Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidenced by written informed consent.

Exclusion Criteria

The subjects will be excluded based on the following criteria during screening and during the study.

i.Subjects incapable of understanding the informed consent process or not ready to sign informed consent.

ii.Subjects with significant history of hypersensitivity to extract of a leafy vegetable, Amaranth or any ingredients of the formulation or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.

iii.Subject with of presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism or excretion of Red Spinach (Amaranth) extract or known to potentiate or predispose to undesired effects.

iv.Subjects with active peptic ulceration or a history of peptic ulceration.

v.Subject with resting hypotension (BP <90 /60) or hypertension (BP > 139 /89).

vi.Subject with Pulse rate below 50/ min. and above 99/min.

vii.Subjects with or prior history of clinically significant, Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.

viii.Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage.

ix.Subjects on current use of organic nitrates.

x.Subjects with a history of known food allergy.

xi.Subjects who have suffered any illness or who have been hospitalized within the last 4 weeks preceding the start of the study.

xii.Use of an investigational device or investigational drug within 90 days or 6 half-lives.

xiii.Subjects who have taken over the counter or prescribed medications, including any enzyme modifying drugs within the last 14 days prior to the study.

xiv.Subject who have a History of alcoholism, drug abuse or Smoking.

xv.Subjects who participated in any other clinical study requiring repeated blood sampling or a blood donation program or blood loss of more than 350 ml, in the past three months (approx. 90 days) (This 350 mL includes the total blood loss that will occur during the study).

xvi.Subject with clinically significant abnormal lab values / abnormal ECG / abnormal Chest X-ray (PA View).

xvii.Subject who has difficulty with donating blood.

xviii.Subject with positive Breath Alcohol Analysis or Urine Drug Screen of abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified