A randomized, double-blind, placebo-controlled, parallel study with an open label placebo extensio

Not Applicable

Registration Number: CTRI/2023/05/052481

Lead Sponsor: Vidya Herbs Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Male and female participants aged 18-35 years (inclusive of both the ages) with a BMI of <= 30 kg/m2.

2.Participants generally in good health status as confirmed by investigator based on clinical history, physical exam, and routine blood analysis.

3.The participant must not have taken any vitamin/mineral/dietary or herbal supplements, 1 month prior to enrollment in the study.

4.Participant must be able & willing to comply with study procedures.

5.Participant willing to sign the informed consent.

Exclusion Criteria

1.History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes.

2.Diagnostic history of any allergies.

3.Intention to use any vitamins and/or minerals and/or dietary and/or herbal supplements during the study period.

4.Participants with the diagnostic history of cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease

5. Participants who had undergone any surgery during last one year.

6.With the history or planning organ transplantation.

7.Smokers and alcohol/drug abuse

8.Pregnant& lactating women.

9.Participant taking any other investigation drug and currently being a part of any other clinical trial/research.

10.Women of childbearing potential who are not willing to follow a reliable and effective contraceptive measure during the study.

11.Any other underlying conditions which might affect immunity and/or the evaluation of the response of the study medication.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change from baseline value of Th1 (interferon-Î³) and Th2 (interleukin-4) between groups. <br/ ><br>2. Change from baseline values of Immunoglobulin (IgG, IgM, and IgA) levels between groups <br/ ><br>3. Change from baseline in Pittsburgh Sleep Quality Index (PSQI)Timepoint: 1. Day 1 (Baseline), Day 30, and Day 60 <br/ ><br>2. Day 1 (Baseline), Day 30, and Day 60 <br/ ><br>3. Day 1 (Baseline), Day 30, and Day 60

Secondary Outcome Measures

Name	Time	Method
1. Hematology and Biochemistry <br/ ><br>2. Occurrence of any AE or SAETimepoint: 1. Screening, Day 30, and Day 60 <br/ ><br>2. Throughout the study;To evaluate the efficacy among the active group for the extended treatment duration in terms of change in Th1 (interferon-Î³), Th2 (interleukin-4), Immunoglobulin (IgG, IgM, and IgA) and sleep quality indexTimepoint: Day 1 (Baseline), Day 30 and Day 60