A study to assess effect of ursolic acid extract in the body of healthy human volunteers

Not Applicable

Completed

• Registration Number: CTRI/2013/04/003596
• Lead Sponsor: Clinfound Clinical Research Services Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2

Inclusion Criteria

â??Healthy human subjects within the age range of 18 to 45 years (both inclusive)

â??Non-smokers since at least six months

â??Overall healthy, having no difficulty with digestion or absorption of food

â??Willingness to provide written informed consent to participate in the study

â??Clearly understanding the procedures and requirements of the study

â??Willing and able to comply with all study procedures and data recording obligations for the entire length of the study

â??Willing to avoid ingesting the following plant derived foods/herbs during the study: apples, bilberries, cranberries, peppermint, oregano, thyme, hawthorn and prunes

â??Body-mass index of ï?³ 18.5 kg/m2 and ï?£ 24.9 kg/m2, with body weight not less than 50 kg

â??Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening

â??Ability and willingness to abstain from alcohol from 48 hours prior to the first dose until after completion of the post treatment follow-up visit (Day 2)

â??Normal 12-lead ECG or one with abnormality considered to be clinically insignificant

â??Normal chest X-ray PA view

â??Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol.

â??Female Subjects

•of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence, or

•post-menopausal for at least 1 year, or

•surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria

â??Personal / family history of allergy or hypersensitivity nutritional supplement, herbal remedy, food, or any of the components of ursolic acid or related drugs

â??Having a systolic blood pressure >140 mm Hg, diastolic blood pressure >90 mm Hg, or blood pressure that would preclude participation in the judgment of the PI/sub-investigator

â??Already taking a nutritional supplement containing ursolic acid and unable to discontinue use 14 days prior to screening

â??History of anaphylaxis or angioedema

â??Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g.congestive heart failure, hepatitis, pancreatitis etc.

â??Presence of any clinically significant abnormal values during screening e.g. significant abnormality of Liver Function Test (LFT), Renal (kidney) Function Test (RFT), etc.

â??Any cardiac, renal or liver impairment, any other organ or system impairment

â??Any type of active malignancy (except non-melanomatous skin malignancies) within the past 5 years

â??History of seizure or psychiatric disorders

â??Presence of disease markers of HIV 1 and 2, and hepatitis B and C virus

â??Being pregnant, planning on becoming pregnant, breast feeding or unwilling to use a medically acceptable form of birth control during the study (with at least one acceptable barrier for a period of one month prior to the beginning of the study until at least three months after study completion) or are surgically sterile or postmenopausal (at least 12 months without a period). As with many supplements, no thorough study of this compound in pregnancy has been reported

â??History of consumption of alcohol for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to check-in and during the study [one drink is equal to one unit of alcohol [one glass wine, half pint beer, and one measure (one ounce) of spirit].

â??History of use of any recreational drug or drug addiction

â??Participation in any clinical trial within the past 3 months

â??Illness within five days prior to dosing

â??Having a pacemaker or any internal medical device

â??Inaccessibility of veins in left and right arm

â??Donation of blood (one unit or 330 mL) within 3 months prior to study admission

â??Use of any prescription drug therapy within four weeks or over-the-counter (OTC) drugs within two weeks prior to study admission or repeated use of drugs within the last four weeks

â??An unusual diet, for whatever reason e.g. low sodium diet, for two weeks prior to study admission

â??Consumption of grapefruit- containing food or beverages within 7 days prior to the study admission.

â??Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 7 days prior to study admission

â??Female volunteers demonstrating a positive test for pregnancy during screening or currently breast-feeding

â??In the opinion of the investigator, not suitable for entry into the study

Study & Design

• Study Type: BA/BE
• Study Design: Not specified