A clinical trial to study the effects of a poly-herbal compound on immune status of healthy human subjects

Phase 2/3

Completed

• Conditions: To see the immunomodulatory effects, clinical trial is being conducted on apparently healthy volunteers of both sexes, aged 20-40 years

• Registration Number: CTRI/2022/05/042366
• Lead Sponsor: Ms Saatvik Enterprises

Brief Summary

There are various types of Rasayana described in Ayurveda which impart strength to immune system in order to support the other bodily systems. Some of these Rasayana substances which are popular immunomodulators like Amalki, Ashwagandha, Tulsi etc. have been included in the study compound. It will be a prospective, randomized, longitudinal, double arm (treatment-control) study to evaluate the immunomodulatory effects of a polyherbal compound OC22, if any. The proposed study will be conducted on two groups i.e. one will be the treatment group and the other will be the no treatment control group. sIntervention ubjects will be administered with 6g powder of Poly-herbal compound with water, once daily i.e. empty stomach in morning for 3 months. Immune modulation will be assessed by Immune Status Questionnaire, IgG and IgM. Pre and post intervention results will be compared.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-05
• Study Completion: 2022-09-16
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1-Apparently Healthy individuals aged 20-40 years of either sex.
• 2-Individuals giving consent for participation.

Exclusion Criteria

• 1-Individuals with chronic co-morbid conditions which might have affected the immune status of the individual.
• 2-Pregnant or lactating mother 3-Person on any interventional drug like vitamin/mineral/hormonal supplements/protein supplements etc.
• or any other nutritional supplements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Immune status as evaluated by ISQ	Baseline | 3 months from Baseline

Secondary Outcome Measures

Name	Time	Method
Changes in Immunoglobulin (IgG, IgM) levels	Baseline

Trial Locations

Locations (1)

GS Ayurveda Medical College and Hospital; 🇮🇳 Ghaziabad, UTTAR PRADESH, India

GS Ayurveda Medical College and Hospital

🇮🇳Ghaziabad, UTTAR PRADESH, India

Vd Shubham Garg

Principal investigator

9997772737

vdshubhamgarg@gmail.com