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.

A Proof of Concept prospective, double-blind, placebo controlled, comparative, randomized, parallel group, multi-centric clinical study to evaluate short-term effect of PHP-Ageing on the physical and emotional well-being of elderly subjects.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000047

Enrollment

180

Registered

2008-04-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Tablet containing Hydro-alcoholic extract of Withania somnifera 150 mg and Bacopa monniera 50mg: 500 mg BD for 6 months Intervention2: Tablet PHP- Ageing containing hydro-alcoholic extr

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary outcome measures will be 10% improvement in the QOL score over and above that obtained in the group receiving placebo, 10% improvement in the symptom score over and above that obtained in the group receiving placebo and less than 10% difference in adverse events (including laboratory variables) between placebo and active treatment groups.Timepoint:	—

Secondary

Measure	Time frame
Not ApplicableTimepoint:	—

Countries

India

Contacts

Public ContactDr. Shilpa Gaikwad

Professor & Head, Dept. of Clinical Pharmacology

urmilathatte@gmail.com022-23014713, 23050347

Outcome results