Rejuvenation effect of Ayurvedic formulation chyavanaprasha in apparently healthy elderly individuals

Clinical Trial to Study the effect of Cyavanaprasha on Aging in Apparently Healthy Elderly Subjects - CAHE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/03/006701

Enrollment

210

Registered

2016-03-03

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Chyavanaprasha: Chyavanaprasha (Lehya)- Ayurvedic formulation (Ref: Ayurvedic Pharmacoepia of India, Part II, Page 13-16.) 12 grams twice daily with milk for 12 weeks Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: 1.Apparently Healthy Males/Females volunteers of age between 60 and 75 years. 2.Willing to participate for 12 weeks.

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

India

Contacts

Public ContactDr G Venkateshwarlu

National Ayurveda Dietetics Research Institute

nadri.bengaluru1@gmail.com080-26562030

Outcome results