Rejuvenation effect of Ayurvedic formulation chyavanaprasha in apparently healthy elderly individuals

Phase 2

Completed

• Registration Number: CTRI/2016/03/006701
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-12-31
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 68

Inclusion Criteria

1.Apparently Healthy Males/Females volunteers of age between 60 and 75 years.

2.Willing to participate for 12 weeks.

Exclusion Criteria

1.Patients with evidence of malignancy.

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

3.Patients having any Cardio vascular disease.

4.Patients with diabetes mellitus HbA1c >6.5 %, FBS >126 mg/dl and PPBS > 200 mg.dl.

5.Patients with concurrent hepatic disorder (defined as Aspartate Amino Transferase (AST) and/ or Alanine Amino Transferase (ALT) >2times upper normal limit), Total Bilirubin, Alkaline Phosphates (ALP) >2 times upper normal limit or Renal disorders (defined as S. Creatinine > 1.4mg/dl).

6.Patients with Pulmonary Dysfunction (Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD], Inflammatory Bowel Disease, Severe Dementia, Severe Infection(s), Non-ambulatory patients or any other condition that may jeopardize the study.

7.Alcoholics and/or drug abusers.

8.Psychiatric diseases.

9.Patients who have completed participation in any other clinical trial during the past six (06) months.

10.Any other conditions, in which, the Investigator thinks, it may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in Quality of life using WHO-QOL-BREF. <br/ ><br>2.Change (improvement) in functional exercise capacity by 6 min. walk test (from baseline with the end of 12th week). <br/ ><br>Timepoint: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in the following laboratory parameters. <br/ ><br>1.HbA1c (baseline & end of 12th week). <br/ ><br>2.CBC (Complete Blood Count) (from baseline with end of 6th & 12th week). <br/ ><br>3.CRP (high sensitivity C-reactive protein) (from baseline with end of 6th & 12th week). <br/ ><br>4.Lipid profile (from baseline with end of 6th & 12th week). <br/ ><br>a.Serum Cholesterol <br/ ><br>b.Serum TG <br/ ><br>c.HDLc <br/ ><br>d.Low Density Lipoprotein LDLc <br/ ><br>e.VLDLc <br/ ><br>Timepoint: 12 weeks