| CTRI Number |
CTRI/2024/06/069251 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [ Selected Relaxation techniques] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Add on effect of selected relaxation techniques with an ayurvedic rejuvenative therapy in improving quality of life among people aged 60-75 years |
|
Scientific Title of Study
|
Add on effect of selected relaxation techniques with punarnava rasayana in improving quality of life among geriatric population aged 60-75 years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shehanas shukoor |
| Designation |
PG Scholar,Dept of Swasthavritta |
| Affiliation |
Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram KERALA |
| Address |
Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram
KERALA
695001
India
Thiruvananthapuram
KERALA
695001
India |
| Phone |
6238831406 |
| Fax |
|
| Email |
shehanasshukoor030@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shehanas shukoor |
| Designation |
PG Scholar,Dept of Swasthavritta |
| Affiliation |
Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram KERALA |
| Address |
Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram
KERALA
695001
India
Thiruvananthapuram
KERALA
695001
India |
| Phone |
6238831406 |
| Fax |
|
| Email |
shehanasshukoor030@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyothi R |
| Designation |
Professor,Dept of Swasthavritta |
| Affiliation |
Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram KERALA |
| Address |
Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram
KERALA
695001
India
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9496291355 |
| Fax |
|
| Email |
drjyothisajeev@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital, Thiruvananthapuram,Kerala-695001,India |
|
|
Primary Sponsor
|
| Name |
Dr Shehanas shukoor |
| Address |
Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram
KERALA
695001
India |
| Type of Sponsor |
Government medical college |
|
|
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 Shehanas shukoor |
Govt Ayurveda Panchakarma Hospital,Poojappura,Thiruvananthapuram |
Geriatric OPD and IPD,Govt Ayurveda Panchakarma Hospital,
Thiruvananthapuram,Kerala
Thiruvananthapuram
KERALA |
6238831406
shehanasshukoor030@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE(IEC) ,Government Ayurveda College,Thiruvananthapuram,Kerala,India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To improve the quality of life of old age people |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Selected Relaxation techniques for 20 minutes along with punarnava churna 12gm with cows milk daily morning 2 hours before breakfast for 60 days., Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other: Punarnava churna 12gm with cows milk daily morning 2 hours before breakfast for 60 days ., Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Participants in the age group of 60-75 years irrespective of sex who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Severe Cognitive Impairment.
2.Patients suffering from severe systemic illnesses.
3.Those who are having milk allergy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life will be assessed before and after the study and follow up will be done after one month using Quality of Life questionnaire 15D |
0th,61st and 91st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life will be assessed before and after the study and follow up will be done after one month using change in blood parameters(Hb,FBS,Total Cholesterol) |
0th,61st and 91st day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ageing is a normal, inevitable biological phenomenon. The ageing process is of course a biological reality which has its own dynamics beyond human control. Geriatrics is the branch of medicine which deals with care of aged. Quality of life is the composite measure of physical, mental and social wellbeing. As age advances , dhatus in the human body gets degenerated, health and functional capacities may decline resulting in poor quality of life. Relaxation techniques help rejuvenate the body and mind creating a sense of awareness and relaxation. It also helps to relieve stress and produce autonomic balance, corrects numerous psychosomatic conditions prevalent in old age. Ayurveda also focused a branch of medicine called Rasayana (Rejuvenation) which exclusively deals with the process of ageing and methods to counter the same. The Punarnava Rasayana mentioned in our classics will restore youthfulness by improving physical and mental health of the old there by enhancing quality of life.
A Quazi experimental study will be performed in 60 participants irrespective of sex, satisfying inclusion and exclusion criteria. Out of 60 participants,30 each will be consecutively selected and allocated alternately to study group and control group. The study group will be made to perform selected relaxation techniques along with punarnava churna / powder 12gm with cow’s milk for 60 days, while the control group is given punarnava churna /powder 12gm with cow’s milk alone for 60 days. The Quality of Life will be assessed before and after the study and a follow up after one month using Quality of life questionnaire 15D and Blood parameters (Hb, FBS, Total Cholesterol).Data will be collected, processed, and conclusions will be made by appropriate statistical methods. |