None listed
Conditions
Interventions
Intervention1: PCA capsule: Test capsule, each capsule is of 500 mg. 4 capsules to be taken 2 hours before breakfast and dinner for 14 days.
Control Intervention1: Identical PCA capsule: Placebo capsu
Sponsors
PCA Biosciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects willing to provide a personally signed and dated informed consent prior to any study procedures; willing to comply with the study instructions and attend all scheduled study visits. 2. Males and females with age between 50 and 65 years, both inclusive. 3. Subjects willing to continue with their existing diet, exercise, and lifestyle habits throughout the study, without any change. 4. Subjects willing and able to comply with study procedures and duration. 5. Subjects willing to take the IP as per protocol defined dose and regime. 6. Non-menopausal & non-castrated women those are willing to use reliable methods of contraception to avoid pregnancy during the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with allergy or sensitivity to any ingredient of Investigational product. 2. Participation in any clinical study within 30 days before randomization. 3. Pregnant and lactating women. 4. Any kind of substance abuse, (alcohol, tobacco, or any other substance). 5. Subjects with uncontrolled metabolic diseases or chronic diseases at the discretion of the Investigator. 6. Subjects with unstable medical conditions as determined by the qualified Investigator. 7. Subjects with any planned surgery during the trial; history of any surgery past 3 months. 8. Current diagnosis of immune-compromised conditions like HIV/AIDS, cancer. 9. History of blood/bleeding disorders; blood donation in the previous 2 months. 10. Individuals who have had COVID-19 in the past three months. 11. Individuals with a history of major arthritis or joint problem. 12. Any other condition that in the qualified investigator’s opinion may have adversely affected the participant’s ability to complete the study or its measures or which may have posed a significant risk to the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Monitoring and documentation of number and type of adverse events including changes in laboratory parameter (Complete blood count with differential, ESR, kidney function, liver function, lipid profile) from Baseline (Day 1) to the end (Day 14) of the study. Timepoint: Day 1, Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the efficacy of PCA capsules as compared to placebo based on personal health assessment test through SF 36 Survey, to evaluate the efficacy of PCA capsules as compared to placebo based on laboratory examinations (HbA1c, fasting blood glucose & post prandial Sugar, Hs CRP, IGF-1, IgA, IgG, CXCL9, GLP1 & Prothrombin time).Timepoint: Day 1, Day 14 | — |
Countries
India
Contacts
Public ContactMr Sohal Pendse
ProRelix Services LLP
Outcome results
None listed