| CTRI Number |
CTRI/2023/01/049188 [Registered on: 24/01/2023] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Quality of life (n of 1 series trial) ] |
| Study Design |
Other |
|
Public Title of Study
|
Ayurveda regimen on quality of life among elderly population in Ballabhgarh.
|
|
Scientific Title of Study
|
An exploratory series of n of 1 responder restricted study of Ayurveda regimen on quality of life
among elderly population in Ballabhgarh district of Haryana- A community based study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Puneet Misra |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 30 Centre for Community Medicine Old OT Block AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
01126593773 |
| Fax |
|
| Email |
drpuneetresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Misra |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 30 Centre for Community Medicine Old OT Block AIIMS
New Delhi
DELHI
110029
India |
| Phone |
01126593773 |
| Fax |
|
| Email |
drpuneetresearch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Misra |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 30 Centre for Community Medicine Old OT Block AIIMS
New Delhi
DELHI
110029
India |
| Phone |
01126593773 |
| Fax |
|
| Email |
drpuneetresearch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research In Ayurveda Sciences |
| Address |
Central Council for Research In Ayurveda Sciences 61-65
Institutional Area Opp D Block Janakpuri New Delhi 110 058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Puneet Misra |
PHC, ballabhgarh, AIIMS, New Delhi |
Comprehensive Rural Health Services Project, Ballabgarh, haryana,uner AIIMS, New Delhi
Faridabad
HARYANA |
011-26593773
doctormisra@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS Delhi |
Approved |
| InstituteEthicsCommitteeAIIMSDelhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
quality of life |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: classical , Procedure details: Ksheer bala oil will be administered in a dose of 60 ml lukewarm at room temperature for period of 35 days. The dose will be kept uniform for the whole treatment period in the treatment regimen. )
(1) Medicine Name: Ayush Rasayana A, Reference: CCRAS coded formulation, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 6 Days(2) Medicine Name: Ayush Rasayana B, Reference: CCRAS coded Formulation, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 750(mg), Frequency: bd, Duration: 264 Days(3) Medicine Name: Laksha Guggulu , Reference: AFI, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 229 Days(4) Medicine Name: Ksheerbala softule, Reference: sahasrayogam, Route: Oral, Dosage Form: Capsules, Dose: 2(ml), Frequency: bd, Duration: 229 Days |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. 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.
3. Participants fit enough to participate and
qualify in the assessment tests while screening.
4. Participants who will voluntarily give consent to participate and comply to the trial
interventions strictly for 9 months. |
|
| ExclusionCriteria |
| Details |
1. Participants with major systemic illness including liver disease, kidney diseases, and malignancy.
2. 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.
5. Participant taking participation in any other clinical trial.
6. Any other condition that the Principle investigator thinks may jeopardize the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in quality of life in terms of Old peoples
Quality Of Life (OPQOL)
Questionnaire at five
different time lines
This is score based and has been used for sample size calculation. |
0 months 3 months 5 months 7 months 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in various haematological and
biochemical, radiological parameters
2. Changes in physical activity using Barthel
index, sleep quality using Pittsburgh Sleep
Quality Index and health using swasthya assessment scale |
Biomarkers viz. inflammatory, bone health, vascular at 0 3 9 months.
questionnaire at 0 3 5 7 9 months
dexa at 0 3 9 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 out
in apparently healthy elderly of age 60 years or more after obtaining their
consent. The screening will be carried out based on the inclusion criteria in
the community of Ballabhgarh District
of Haryana.
The enrolled participants will
be administered the treatment modality for a run-in period of three months
following which they will be divided into responders and non-responders. Only
responders 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.
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