A clinical study to see the effects of Ayurvedic Formulation in Apparently Healthy Elderly Persons.

Phase 2

• Registration Number: CTRI/2015/03/005659
• Lead Sponsor: CCRAS New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

Criteria for Inclusion :

1.Apparently Healthy Male/ Female on clinical examination of age between 50-75 years.

2.Patients complaining of general weakness and other vague complaints not including the involvement of any particular system.

3.Willing to participate

Exclusion Criteria

1.Patients with evidence of malignancy

2.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-endocrinal disorder etc).

3.Patients who have a past history of Atrial Fibrillation, Coronary Artery Disease (CAD) Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

4.Symptomatic patient with clinical evidence of Heart failure.

5.Uncontrolled Hypertensive (taking more than two drugs)

6.Patients on Prolonged ( >6 weeks) medication with corticosteroids, antidepressants, anticholinergics etc. or any other drugs that may have an influence on the outcomes of the study.

7.Patients with concurrent serious hepatic disorder (defined as Aspatate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) >2 times upper normal limit or Renal Disorder (defined as S. Creatinine > 1.2 mg/dL).

8. Patients with severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease (COPD), Inflammatory Bowel Disease, Serve Dementia, Severe Infection(s), Non-ambulatory patients or nay other condition that may jeopardize the study.

9.Prostate Specific Antigen (PSA) level >4 ng/mL.

10.Alcoholics and/ or drugs abusers.

11.Pregnant/ lactating womenâ??s

12.Patients suffering from uncontrolled Diabetes {HbAlc >9%)

13.HIV positive subjects.

14.H/o hypersensitivity to the trial drug or any of its ingredients.

15.Patients who have complete participation in nay other clinical trial during the past (06) months.

16.Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified