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CTRI Number  CTRI/2015/04/005679 [Registered on: 08/04/2015] Trial Registered Retrospectively
Last Modified On: 10/10/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Preventive 
Study Design  Other 
Public Title of Study   Study for apparently healthy elderly people (within 60 to 75 years age) by giving an ayurvedic drug made up of herbal extracts to see its efficacy of enhancing and maintaining their healthy state. 
Scientific Title of Study   COLLABORATIVE MULTICENTRIC CLINICAL TRIAL TO STUDY THE EFFECT OF AYUSH RASAYANA (A&B)ON APPARENTLY HEALTHY ELDERLY SUBJECTS. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof A B Dey 
Designation  Professor & Head, Department of Geriatric Medicine 
Affiliation  AIIMS, New Delhi 
Address  Room No. 3091, Department of Geriatric Medicine, Teaching Block, All India Institute of Medical Sciences, New Delhi
Department of Geriatric Medicine. All India Institute of medical Sciences New Delhi,110029
South
DELHI
110029
India 
Phone  01126596606  
Fax  01126588663  
Email  abdey@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof A B Dey 
Designation  Professor & Head, Department of Geriatric Medicine 
Affiliation  AIIMS, New Delhi 
Address  Room No. 3091, Department of Geriatric Medicine, Teaching Block, All India Institute of Medical Sciences, New Delhi
Department of Geriatric Medicine. All India Institute of medical Sciences New Delhi,110029
South
DELHI
110029
India 
Phone  01126596606  
Fax  01126588663  
Email  abdey@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pallavi Mundada 
Designation  Senior Research Fellow 
Affiliation  AIIMS, New Delhi 
Address  Department of Geriatric Medicine. All India Institute of medical Sciences New Delhi
Department of Geriatric Medicine. All India Institute of Medical Sciences New Delhi,110029
South
DELHI
110029
India 
Phone  01126546074  
Fax  01126588663  
Email  aiims.rasayana@gmail.com  
 
Source of Monetary or Material Support  
Central Council of Research in Ayurvedic Sciences, Dept. of AYUSH, Ministry of Health and Family Welfare, Govt. of India 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences CCRAS 
Address  Jawahar lal Nehru Bhartiya Chikisa Evam Homoeopathy Anusandhan Bhawan No. 61-65, Institutional Area, Opposite D-Block, Janakpuri, New Delhi - 110058 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Inderjeet Singh Gambhir  IMS, BHU, Varanasi, U.P.   Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P.
Varanasi
UTTAR PRADESH 		 09415255998

gambhir_bhu@yahoo.com 
Prof A B Dey  AIIMS, New Delhi  Department of Geriatric Medicine. All India Institute of Medical Sciences New Delhi,110029
South
DELHI 		 98568397241
01126588663
abdey@hotmail.com 
Dr J R Hazra  National Research Institute for Ayurveda Drug Development  National Research Institute for Ayurveda Drug Development, 4-CN Block, Sector-5 Bidhan Nagar, Kolkata-700091
Kolkata
WEST BENGAL 		 9830054142

jayramhazra@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institute ethical committe, IMS, BHU  Approved 
Institute Ethics Committee, AIIMS  Approved 
Institutional ethical committe, NRIADD, Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy volunteers of both sexes, Age 60-75 yrs. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AYUSH Rasayana A, AYUSH Rasayana B  5 grams of Ayush Rasayana ‘A’ contains 1.5 gm each of 3 herbs and 0.5 gm rock salt. Dose- 10 grams powder HS orally with lukewarm water, for first 6 days. 
Intervention  AYUSH Rasayana B  750 mg of AYUSH Rasayana ‘B’ contains 250 mg extract of 3 herbs each. Dose- 750mg twice a day before meals with lukewarm water from 7th day onwards daily upto 186th day. Total duration of study 6 months. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  • Apparently healthy volunteers
• Willing to participate in the study
Note : The subjects with grade-1 Hypertension and/ or Hb% up to minimum 11gm% may also be included in the study with careful data recording.  
 
ExclusionCriteria 
Details  • Age< 60yrs or >75yrs
• Participated in similar study previously or participating in any ongoing study
• Hypertensives with BP>160/100mmHg
• Subjects with HB<11gm%
• Active/ chronic liver, kidney disease or Heart diseases
• Severe disabled bedridden patients unable to go through the assessment
• Psychiatric diseases
• Diabetes with blood sugar more than 125mg % fasting and 200mg% PP
• Any illness, according to PI, which is not conducive to the trial
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Any improvement in functional exercise capacity by 6 min. walk test
2. Any improvement in subjective QOL, using WHO QOL. 		 0 Day (Baseline)
37th Day
97th Day
187th Day. 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1.Any improvement in cognitive functioning:HMSE scale.
2.Any change in pro-inflammatory marker: hsCRP (high sensitivity C-reactive protein)
3.Any change in
•CBC and ESR
•Blood sugars F& PP
•HbA1C
•S. lipids
•Blood urea
•S. Cortisol
S. Creatinine
•DHEA-S
•Serum Total Protein , S. Albumin, S. Globulin
4.Creatinine Clearance Test
5.Any improvement in cardiovascular health:
blood pressure, Resting pulse rate, pulse pressure. 		 0 Day (Baseline)
37th Day(Excluding Sr. Cortisol, DHEA-S, Creatinine Clearance, Sr. Protein)
97th Day
187th Day. 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
Final Enrollment numbers achieved (Total)= "256"
Final Enrollment numbers achieved (India)="256" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  		 22/04/2015 
Date of Study Completion (India) 31/05/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

This is a research study being conducted as multicentric collaborative clinical research project sponsored by the Central Council for Research in Ayurvedic Sciences (CCRAS), Department of AYUSH, Ministry of Health & Family Welfare, Government of India, involving administration of Ayush Rasayana ‘A’ & ‘B’ with a view to scientifically document the clinical efficacy and safety of the said Ayurvedic formulations that have been in use since thousands of years for the promotion of general health, physical fitness and endurance.

The Rasayana drugs are said to have Anti-inflammatory, Anti-oxidant, Immuno-modulatory properties and have beneficial effects on cognitive functioning, physical fitness and endurance.

This study is a Open Label, clinical trial to see the effect of Ayurvedic Coded drugs (Ayush Rasayana A & B) on ageing in apparently healthy elderly subjects. The age group of the subjects selected for this study will be 60-75 years and they will be put on a trial for a period of 186 days (approx. 6 months)

Composition Of AYUSH Rasayana A:

5 grams of Ayush Rasayana ‘A’ contains 1.5 gm each of 3 herbs and 0.5 gm rock salt.

Composition of AYUSH Rasayana B:

750 mg of Ayush Rasayana ‘B’ contains 250 mg extract of 3 herbs each.

Acute, sub acute and chronic toxicity studies have been conducted with either of the trial drugs on mice and rats. The drugs were found safe experimentally.

PRIMARY OBJECTIVES

<!--[if !supportLists]-->·         <!--[endif]-->To see the efficacy of Rasayana drugs in improving the general body health and quality of life in elderly people.

SECONDARY OBJECTIVES

<!--[if !supportLists]-->·         <!--[endif]-->To observe the changes in bio-chemical profile and other health parameters.

<!--[if !supportLists]-->·         <!--[endif]-->To see the safety of the Rasayana drugs as anti-ageing formulations. 

 

 

"The Date of first enrolment is 22nd April 2015 actually. It was by mistake typed 20th February previously. The trial was registered on 8th April 2015. Since we have started enrolling the patients after the registration was complete officially, our trial is a prospective study."

 
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