safety and anti-aging efficacy of orally administered herbal extract formulations in elderly healthy individuals
- Conditions
- Aging
- Registration Number
- CTRI/2022/09/045375
- Lead Sponsor
- Pharmanza Herbal
- Brief Summary
This study is an attempt to test the anti-aging property of Ashwagandha, Nishamalaki by testing the changes in physical activity using walking speed and hand grip, telomere length and cell senescence in peripheral blood mononuclear cells, aging biomarkers including Sirt 1, Sirt 6, NAD+ and DNA methylation, blood glucose levels and insulin resistance and the safety of these herbal formulations by assessing vital signs and biochemical investigations (hematology, lipid profile, liver function test) groups. the changes in these parameters will be compared between 0 and 24 weeks and the difference between the herbal formulations and that seen in placebo group will be compared to derive the anti aging property of these herbal compounds.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 48
- 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.
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
- Primary Outcome Measures
Name Time Method 3 minute walk test 0, 12 and 24 weeks hand grip strength test 0, 12 and 24 weeks MMSE 0, 12 and 24 weeks Telomere length, cellular senescence -PBMC 0, 12 and 24 weeks Sirt 1, Sirt 6, NAD+ and DNA methylation assay 0, 12 and 24 weeks
- Secondary Outcome Measures
Name Time Method safety testing LFT RFT 0 and 24 weeks
Trial Locations
- Locations (1)
SRM Medical College Hospital & Research Centre
🇮🇳Kancheepuram, TAMIL NADU, India
SRM Medical College Hospital & Research Centre🇮🇳Kancheepuram, TAMIL NADU, IndiaMelvin GeorgePrincipal investigator9894133697melvingeorge2003@gmail.com