Ayurveda regimen on quality of life among elderly population in Ballabhgarh.

Phase 2/3

Recruiting

Brief Summary: | | |

| --- | --- |

|This project targets the geriatric age group and intends to assess the effect of Rasayana on the process of ageing. The outcome measures taken before, during, and at the conclusion of an intervention could be used to estimate how the approach/ intervention might change the rate of age-dependent deterioration in system integrity. It will provide leads in curbing deterioration in the physical activity, social outlook and cognitive functions of the geriatric population. This is an exploratory study and the selected ayurveda regimen will be implemented in community first time.

| |

| --- |

| The study will be carried outin apparently healthy elderly of age 60 years or more after obtaining theirconsent. The screening will be carried out based on the inclusion criteria inthe community of Ballabhgarh Districtof Haryana. The enrolled participants willbe administered the treatment modality for a run-in period of three monthsfollowing which they will be divided into responders and non-responders. Onlyresponders will be recruited for the actual interventional study

Study Type- Series of N of 1 responder restricted design. Purpose-Impact assessment on quality of life in geriatric population.

Recruitment & Eligibility

Inclusion Criteria

Clinically stable participants who have completed 60 years of age of either gender (Screening assessments for clinically stable participants will be done on the basis of medical history, physical examination, safety laboratory tests (CBC, ESR, LFT, RFT, FBS, PPBS, Lipid profile, VDRL), vital signs, ECG, X-ray) 2.
Participants should be in generally good health and those with chronic diseases should be (hypertension, coronary artery disease, etc.) clinically stable with medication and should not affect the day to day activities.
Participants fit enough to participate and qualify in the assessment tests while screening.
Participants who will voluntarily give consent to participate and comply to the trial interventions strictly for 9 months.

Exclusion Criteria

Participants with major systemic illness including liver disease, kidney diseases, and malignancy.
Cardiovascular diseases (unstable ischemic heart disease, etc) or uncontrolled blood pressure (>180/110 mmHg) 3.
Uncontrolled Diabetes Mellitus (HbA1C > 8%) 4.
Cognitive impairment, neuro-psychiatric diseases which would render the participants unable to participate in the assessment tests.
Participant taking participation in any other clinical trial.
Any other condition that the Principle investigator thinks may jeopardize the study.

Primary Outcome Measures

Name	Time	Method
different time lines	0 months 3 months 5 months 7 months 9 months
Change in quality of life in terms of Old peoples	0 months 3 months 5 months 7 months 9 months
Quality Of Life (OPQOL)	0 months 3 months 5 months 7 months 9 months
Questionnaire at five	0 months 3 months 5 months 7 months 9 months
This is score based and has been used for sample size calculation.	0 months 3 months 5 months 7 months 9 months

Secondary Outcome Measures

Name	Time	Method
1. Change in various haematological and	biochemical, radiological parameters

Locations (1): PHC, ballabhgarh, AIIMS, New Delhi
🇮🇳
Faridabad, HARYANA, India
PHC, ballabhgarh, AIIMS, New Delhi
🇮🇳Faridabad, HARYANA, India
Dr Puneet Misra
Principal investigator
011-26593773
doctormisra@gmail.com