Assessment of effect of health supplements in healthy humans.

Phase 2

• Registration Number: CTRI/2024/03/064117
• Lead Sponsor: HERBOLAB INDIA PVT LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Healthy male and female human trial participants aged between 18 and 60 years (both inclusive);2. Female trial participants must have a negative urine pregnancy test prior to the housing;3. Male and females agreeing to use the contraceptive pill or abstinence as a method of contraception during and 07 days after completion of the study;4. Trial participants with a BMI between 18.50-29.90 kg per m2 and body mass, not less than 50.00 kg;5. Trial participants in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests).

Exclusion Criteria

1.Incapable of understanding the informed consent information;

2.Clinically significant medical condition, such as, but not limited to,

cardiovascular, neurological, psychiatric, pulmonary, renal,

immunological, endocrine (including uncontrolled diabetes or thyroid

disease), or uncontrolled haematological abnormalities;

3.History or presence of alcoholism or drug abuse;

4.History or presence of cancer;

5.Use of any prescribed medication (including herbal remedies)

during the two weeks before the start of the study or OTC medicinalproducts (including herbal remedies) during the week before study initiation and throughout the study;

6.Major illness during the 90 days before screening;

7.Pregnant women and nursing mothers;

8.Males and females of childbearing potential unwilling to employ appropriate and reliable method of contraception during the study till 07 days after the completion of the study;

9.Consumption of dietary supplements likely to provide

constituents similar to the investigational product in last 3 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Assessment, Adverse events, Changes in CBC, LFT, and RFT parameters on screening and day 30.Timepoint: Screening and day 30.

Secondary Outcome Measures

Name	Time	Method
Efficacy testing by questionnaires.Timepoint: screening and day 30.