None listed
Conditions
Interventions
Intervention1: Group A: LS/ 24-25/Imm001: One Capsule Twice a day after a main meal for 90 days.
Intervention2: Group B: LS/ 24-25/Imm002: One Capsule Twice a day after a main meal for 90 days.
Contro
Sponsors
Life Synergy
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 35 to 60 years (both the ages inclusive) 2. With any one condition prevalent- recurrent upper respiratory tract infection, seasonal asthma, allergic rhinitis, skin allergies 3. Ready to provide written informed consent 4. Subjects with or without the known infection of Covid 19. If known case the Covid 19 infection should not be in the active phase that is within 3 months of infection 5. Subjects with or without vaccinated with SARS Cov 2 vaccine (Any vaccine available in India) 6. No history of any known allergy with herbal products or any of the ingredients of the test product 7. Willing to comply with all requirements of the trial procedure. 8. Subjects with or without comorbidities, if comorbidity exists should be on stable prescription and with following criteria Hypertension (140 by 90 mmHg on prescription), Type 2 DM (HbA1C less than or equal to 7.5 on prescription) etc.
Exclusion criteria
Exclusion criteria: 1. Subject in the active phase of Covid 19 infection or recovered with persistent symptoms or as per discretion of the investigator 2. Patients with known uncontrolled diabetes mellitus (DM) HbA1C more than 7.5 hypertension (HT) symptomatic congestive heart failure (CHF) unstable angina pectoris myocardial infarction (MI) 3. Subjects with a current medical history of any major illness such as cancer, heart disease as per investigator opinion 4. Patients participated in another clinical drug trial within 3 months before recruitment in this trial 5. Any other medical condition that in the Investigators opinion would preclude patient participation 6. Pregnant and breastfeeding women 7. Immunologically compromised individuals 8. Subjects with past history of addiction abuse and rehabilitation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of the Immunity Formula by assessing- 1. Immunity markers- Changes in immunoglobulin IgG and IgM 2. Inflammation markers-Changes in inflammatory markers like CRP, IL-6 3. Antioxidant markers-Changes in antioxidant markers like GSH, CAT, SODTimepoint: 1. screening, and 90 2. screening, and 90 3. screening, and 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical markers- 1.Change in fatigue severity score 2.Changes in digestive behavior: digestive complaints like bloating, constipation, postprandial fullness, hyperacidity 3.Overall well-being (SF-12 Health Survey) 4.Incidence of subjects presenting with respiratory symptoms during the study 5.Improvement in the immune status based on the adapted Immune status Questionnaire (ISQ)Timepoint: 1.screening, day 30, 60 and 90 2.screening, day 30, 60 and 90 3.screening, day 30, 60 and 90 4.screening, day 30, 60 and 90 5.screening, day 30, 60 and 90 | — |
Countries
India
Contacts
Public ContactDr Vaishnavi Patil
Life Synergy
Outcome results
None listed