clinical trail to evaluate efficacy and safety of Vestige Noni capsules in improving Overall health of healthy population.
- Registration Number
- CTRI/2022/09/045314
- Lead Sponsor
- Vestige Marketing Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1 Subject is willing and able to give written informed consent.
2 Aged 18-65 years of age
3 Subject is willing, able, and likely to comply with all study procedures and restrictions
1 Current or 12 months prior to screening severe cardiovascular diseases, including: NYHA Class III or IV chronic heart failure, clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction, heart and coronary vessel surgery, significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg, pulmonary embolism or deep vein thrombosis.
2 Type 1 diabetes mellitus and uncontrolled type 2 diabetes mellitus (HbA1c > 10.5 %, fasting plasma glucose >270 mg/dl at screening or episodes of severe hypoglycemia 1 month prior to screening);
3 Severe diseases of the central nervous system, including seizures in history or conditions that may lead to their development; stroke or transient ischemic attack within 12 months prior to screening; head injuries or loss of consciousness within 12 months prior to screening; a brain tumor.
4 Significant uncontrolled concomitant disease, such as neurological, renal, hepatic, endocrine and gastrointestinal which according to the Investigator, could prevent the patient from participating in the study.
5 Participation in other clinical studies or administration of investigational products within 4 weeks prior to screening.
6 HIV, active viral (hepatitis B and C) or a cirrhotic liver disease in medical history.
7 Malignancies within the last 5 years (except for basal cell carcinoma of the skin and cervical cancer in situ that had undergone surgical removal or treatment).
8 Drug or alcohol abuse at the time of screening or in the past which, in the opinion of the Investigator, makes the patient unsuitable for participation in the study.
9 Pregnant or lactating women or women planning a pregnancy during the clinical study.
10 Inability to read or write, unwillingness to understand and follow procedures of study protocol, as well as any other concomitant medical or serious mental conditions that make the patient unfit to participate in the study, limit the legality of obtaining informed consent or can affect patient’s ability to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in Health-related quality of life- SF 36 QuestionnairesTimepoint: Day 0 to Day 30
- Secondary Outcome Measures
Name Time Method •Mean Change in the Short General Health Questionnaire (GHQ 12) score <br/ ><br> <br/ ><br>•Safety and tolerability of the study drug(s) will be assessed by the Clinical AEs occurring during entire duration of study. <br/ ><br>Timepoint: Day 0 to Day 30