MedPath

A clinical trial to study the effects of 2 Ayurvedic formulations, containing Ashwagandha, Brahmi and Amalaki on the physical and emotional well-being of elderly subjects.

Phase 2
Registration Number
CTRI/2008/091/000047
Lead Sponsor
Council of Scientific & Industrial Research, New Delhi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
180
Inclusion Criteria

Individuals satisfying all the following criteria will be included in the study
1.Individuals between the age group of 65 - 75years of either sex
2.Those who fit into either Grades 1 or 2 on the Objective physical health scale (as described below)
Objective physical health:
Grade 1: without any irreversible illness
Grade 2: minor irreversible illness that is neither life shortening nor disabling (e.g., treatable glaucoma, controlled primary hypertension, non-crippling arthritis, controlled diabetes on oral anti-diabetic agents)
Grade 3: irreversible life-threatening illness (e.g., coronary thrombosis or diabetic patients on insulin)
Grade 4: irreversible illness with significant disability (e.g. multiple sclerosis, chronic congestive heart failure).1
3.Individuals ready to abide by trial procedures and to give informed consent.

Exclusion Criteria

Individuals suffering from any of the following conditions will be excluded from the study.
1.History of intake of ANY Ayurvedic/herbal/homeopathic/ dietary supplements (including Vitamin E) or any alternative therapies in the last one month.
2.Liver, kidney and/or bone marrow disorders
3.Acute medical/surgical complications which require hospitalization
4.History of cardiac rhythm disorders with or without pacemakers.
5.History of alcohol abuse, excessive smoking (more than 10 cigarettes/day)
6.Established/ diagnosed neurological or psychiatric disorders

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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