safety and anti-aging efficacy of orally administered herbal extract formulations in elderly healthy individuals

Phase 2

• Registration Number: CTRI/2022/09/045375
• Lead Sponsor: Pharmanza Herbal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients above 60 years of age belonging to either gender (males/females)

2.Fasting plasma glucose < 126 mg/dl, 2-hr glucose between 140 - 199 mg/dl

3.Patients willing to follow all trial procedures.

Exclusion Criteria

Patients suffering from systemic illness necessitating long term drug treatment rheumatoid arthritis psychoneuroendocrinal disorders

Patients having any cardiovascular disease

Patients with diabetes mellitus HbA1c >6.5 FBS >126 mg/dl and PPBS > 200 mgdl

Patients with the concurrent hepatic disorder (defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2 times upper normal limit, total bilirubin alkaline phosphates (ALP) >2 times the upper normal limit

Renal disorder is defined as S Creatinine > 3 mgdl

Patients with pulmonary dysfunction bronchial asthma and chronic obstructive pulmonary disease COPD

Inflammatory bowel disease

Severe dementia

Severe infection

Non-ambulatory patients or any other condition that may jeopardize the study

Subjects who are currently alcoholics and/or use psychoactive substances patients who have completed participation in any other clinical trial during the past 6 months

Subjects who have a history of allergy hypersensitivity or intolerance to investigational product

Subjects who have a history or evidence of active infection or febrile illness within 7 days prior to the screening assessment and subjects who have a history of any other clinically significant disease or disorder that, in the opinion of the principal investigator, may place the subject at risk due to participation in the study, or may influence the results of the study or the subject ability to complete the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified