Health Condition 1: D849- Immunodeficiency, unspecified
Conditions
Interventions
Intervention1: Immunity Booster Capsules: Immunity Booster Capsules is a nutraceutical product, formulated as a capsule which has Shitake mushroom extract (30% Polysachharides- AHCC), Vitamin D3 (Chol
Sponsors
Amitojas Wellness Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18 years and above. 2. Subjects with general immunodeficiency as determined by the study investigator. 3. Subjects who are prone to seasonal immunity associated illnesses as determined by the study investigator 4. Subjects willing to provide informed written consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant, planning to become pregnant or breastfeeding women. 2. Subjects with significant medical/surgical condition which requires long-term treatment. 3. Subjects who are currently being treated with other immunostimulant drugs. 4. Current or past history of a serious illness including, seizures, major psychiatric illness, structural brain disease, liver or kidney failure, organ transplantation, rheumatoid arthritis, uncontrolled hypertension, uncontrolled diabetes or malignancy, cardiovascular event in the last three months. 5. Alcohol or substance abuse 6. Allergy or sensitivity to any of the ingredients in the study treatment 7. Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly. 8. Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total leucocyte count (TLC), absolute lymphocyte count (ALC) and lymphocyte percentage documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)Timepoint: baseline and day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of immunity associated illness (allergy and infection) documented in the CRF at baseline, day 15 and day 30 (values within the group and between the groups comparisons)Timepoint: baseline, day 15 and day 30;Episodes of immunity associated illness (allergy and infection) documented in the CRF at baseline, day 15 and day 30 (values within the group and between the groups comparisons).Timepoint: baseline, day 15 and day 30;Number of subjects having immunity associated illness (allergy and infection) documented in the CRF at baseline, day 15 and day 30 (values within the group and between the groups comparisons)Timepoint: baseline, day 15 and day 30;Serum immunoglobulins (IgM, IgG and IgA) and natural killer cells levels documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)Timepoint: baseline and day 30;Severity of immunity associated illness (allergy and infection) documented in the CRF at baseline, day 15 and day 30 (values within the group and between the groups comparisons)Timepoint: baseline, day 15 and day 30 | — |
Countries
India
Contacts
Public ContactMr Kamal Kammili
Amitojas Wellness Private Limited
Outcome results
None listed