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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 20 July 2014
Main ID:  CTRI/2008/091/000047
Date of registration: 30-04-2008
Primary sponsor: Council of Scientific & Industrial Research, New Delhi
Public title: 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.
Scientific title: 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.
Date of first enrolment: 01-05-2008
Target sample size: 180
Recruitment status: Not Yet Recruiting
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=89
Study type:  Interventional
Study design:  Randomized, Parallel Group, Multiple Arm Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
 
Countries of recruitment
India
Contacts
Name: Dr. Urmila Thatte 
Address:  Professor & Head, Dept. of Clinical Pharmacology TNMC & BYL Nair Hospital, Mumbai Central, 400 008 Mumbai, MAHARASHTRA India
Telephone: 022-23014713, 23050347
Email: urmilathatte@gmail.com
Affiliation:  Professor & Head, Dept. of Clinical Pharmacology
Name: Dr. Shilpa Gaikwad 
Address:  Study Coordinator, TNMC & BYL Nair Hospital, Mumbai Central 400 008 Mumbai, MAHARASHTRA India
Telephone: 022-23014713, 23050347
Email: urmilathatte@gmail.com
Affiliation:  Professor & Head, Dept. of Clinical Pharmacology
Key inclusion & exclusion 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: 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


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Quality of Life in elderly subjects
Intervention(s)
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 extracts of Withania somnifera 150mg and Phyllanthus emblica 200 mg: 500 mg BD for 6 months
Control Intervention1: Tablet Placebo: 500 mg BD for 6 months
Primary Outcome(s)
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 Outcome(s)
Not ApplicableTimepoint:
Secondary ID(s)
PHP/CSIR/2006/4
Source(s) of Monetary Support
Council of Scientific & Industrial Research, New Delhi
Secondary Sponsor(s)
Indian Institute of Integrative Medicine, Jammu
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