Health Condition 1: D849- Immunodeficiency, unspecified
Conditions
Interventions
Intervention1: DS/IMC01/CT01/25: One capsule once a day, orally after breakfast for 90 days.
Control Intervention1: NIL: NIL
Sponsors
Dharampal Satyapal Foods Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged 35 to 60 years both 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. Participants with or without a known infection of COVID 19. If a known case of COVID-19 infection should not be in the active phase that is within 3 months of infection 5. Participants with or without vaccinated with SARS Cov 2 vaccine (Any vaccine available in India) 6. No history of any known allergy to herbal products or any of the ingredients of the investigational product 7. Willing to comply with all requirements of the trial procedure 8. Participants with or without comorbidities if comorbidity exists should be on stable prescription and with the following criteria Hypertension less than or equal to 140/90 mmHg on prescription, Type 2 DM (HbA1C less than or equal to 7.5 on prescription) etc
Exclusion criteria
Exclusion criteria: 1. Participants in the active phase of COVID 19 infection or recovered with persistent symptoms or as per discretion of the investigator 2. Participants with known uncontrolled diabetes mellitus (DM), HbA1C more than 7.5, hypertension HT symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction 3. Participants with a current medical history of any major illness such as cancer or heart disease as per the investigators opinion 4. Participants 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 participation 6. Pregnant and breastfeeding women 7. Immunologically compromised individual participants with a history of addiction abuse and rehabilitation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunity markers- 1. Changes in immunoglobulin IgG and IgM 2. Changes in Vitamin D3 levels Inflammation markers- 1. Changes in inflammatory markers like CRP 2. Changes in IL-6 levelsTimepoint: Screening, day 45 and day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in fatigue severity scale (FSS) score 2. Changes in digestive behaviour assessed by a 4-point ordinal scale score for digestive complaints like bloating, constipation, postprandial fullness, and hyperacidity 3. Overall well-being using SF-12 Health Survey score 4. Incidence of participants presenting with respiratory symptoms during the study 5. Improvement in the immune status based on the adapted Immune Status Questionnaire (ISQ) score Timepoint: Screening, day 45 and day 90. | — |
Countries
India
Contacts
Public ContactMr Munish Singla
Dharampal Satyapal Foods Limited
Outcome results
None listed