Clinical trial on healthy subjects for general health

A non-randomized, uncontrolled, open label single arm trial to evaluate the safety of a poly-herbal formulation, iVed in healthy human subjects

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/02/031064

Enrollment

Registered

2021-02-05

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

None listed

Interventions

Intervention1: iVED Poly Herbal formulation: Day 0,Day 30 and Day 60 Route administration: Orally Dosage 30 ml preferably twice a day, directly half an hour before food Treatment duration:60 days

Eligibility

Inclusion criteria

Inclusion criteria: 1.Men and women aged 18-55 years 2.Healthy subjects as determined by: Medical history, Physical examination and Clinical judgment of the investigator 3.Subject willing to provide written informed consent and comes for regular follow up

Exclusion criteria

Exclusion criteria: 1. A know history or present condition of allergic response to any pharmaceutical products and supplements. 2. History of major cardiovascular events in the last 1 year (stroke or myocardial infraction). 3. Gastrointestinal(i.e. inflammatory bowel disease, celiac), liver(ASL/ALT above two times the upper limit of normal) or kidney disease (eGFR 4. Cardiac condition that compromises normal function (e.g. mitral valve disease, heart failure). 5. Female subjects who are pregnant, lactating or planning to become pregnant during the study period. 6. Post-menopausal female subjects. 7. History of drug dependence or any severe co-morbid medical conditions. 8. High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine/Caffeine dependence or chronic smoker. 9. Administration of any other multivitamins/herbal product/wellness products 10. Subject has participated in a clinical study within the last 30 days prior to entering this study

Design outcomes

Primary

Measure	Time frame
To evaluate the safety of iVed in healthy human subjects from baseline to end of the trial Timepoint: Baseline, 4 weeks and 8 weeks	—

Secondary

Measure	Time frame
To assess the general health maintenance based on Quality of Life Questionnaire.Timepoint: Day 0 and Day 60	—

Countries

India

Contacts

Public ContactDr Balu kolar

Radiant Research Services Pvt Ltd

ashok@radiantresearch.in9880999297

Outcome results