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.
- Conditions
- Healthy volunteers of both sexes, Age 60-75 yrs.
- Registration Number
- CTRI/2015/04/005679
- Lead Sponsor
- Central Council for Research in Ayurvedic Sciences CCRAS
- Brief Summary
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.xml:namespace prefix = "o" /
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."**
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 240
•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.
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Any improvement in functional exercise capacity by 6 min. walk test 0 Day (Baseline) | 37th Day | 97th Day | 187th Day. 2.Any improvement in subjective QOL, using WHO QOL. 0 Day (Baseline) | 37th Day | 97th Day | 187th Day.
- Secondary Outcome Measures
Name Time Method 1.Any improvement in cognitive functioning:HMSE scale. 2.Any change in pro-inflammatory marker: hsCRP (high sensitivity C-reactive protein)
Trial Locations
- Locations (3)
IMS, BHU, Varanasi, U.P.
🇮🇳Varanasi, UTTAR PRADESH, India
AIIMS, New Delhi
🇮🇳South, DELHI, India
National Research Institute for Ayurveda Drug Development
🇮🇳Kolkata, WEST BENGAL, India
IMS, BHU, Varanasi, U.P.🇮🇳Varanasi, UTTAR PRADESH, IndiaProf Inderjeet Singh GambhirPrincipal investigator09415255998gambhir_bhu@yahoo.com