| CTRI Number |
CTRI/2025/11/096826 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
A study to find how Bhringarajadi choorna with lifestyle changes improves quality of life in older adults aged 60 to 75 years compared to lifestyle changes alone |
|
Scientific Title of Study
|
Effect of Bhringarajadi choorna and Lifestyle modifications in Quality of Life in Geriatric Population Aged 60 to 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 Rugma Mukundan |
| Designation |
PG scholar Department of Swasthavritta |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
Government Ayurveda Medical College and Hospital, Pulimoodu
junction,
Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
7306682540 |
| Fax |
|
| Email |
rugmamukundan1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rugma Mukundan |
| Designation |
PG scholar Department of Swasthavritta |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
Government Ayurveda Medical College and Hospital, Pulimoodu
junction,
Thiruvananthapuram
KERALA
695001
India |
| Phone |
7306682540 |
| Fax |
|
| Email |
rugmamukundan1997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheela S |
| Designation |
Professor and HOD,Department of Swasthavritta |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
Government Ayurveda Medical College and Hospital, Pulimoodu
junction,Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9847706888 |
| Fax |
|
| Email |
drsheelas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital,Pulimoodu
Junction,Thiruvananthapuram-695001,Kerala,India |
|
|
Primary Sponsor
|
| Name |
Rugma Mukundan |
| Address |
PG Scholar,Government Ayurveda Medical College and
Hospital,Pulimoodu Junction,Thiruvananthapuram-695001 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Rugma Mukundan |
Government Ayurveda Medical College and Hospital, Pulimood Junction, Trivandrum |
Department of
Swasthavritta, OP No 2
,Poojappura,
Thiruvananthapuram,
Kerala
Thiruvananthapuram
Thiruvananthapuram
KERALA |
7306682540
rugmamukundan1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Government Ayurveda College Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants with age group 60 to 75 years with no major systemic illness |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhringarajadi choorna , Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -jaggery), Additional Information: -12gm choorna with 3gm jaggery twice daiy | | 2 | Comparator Arm (Non Ayurveda) | | - | ICMR GUIDELINES | ICMR recommends a balanced diet with cereals, pulses, fruits, vegetables, milk, nuts, and limited salt, sugar, and fat. Regular physical activity, adequate sleep, stress control, and avoiding tobacco and alcohol are advised. For the elderly, soft, easily digestible, and nutrient-rich foods with light daily exercise help maintain good health and quality of life. |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged 60 to 75 years irrespective of gender with no chronic systemic illness |
|
| ExclusionCriteria |
| Details |
1) Severe Cognitive Impairment
2) Participants with chronic systemic illness
3) Malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life of participants using quality of life questionnaire 15D |
0th day, 46th day and 76th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in blood parameters ( FBS, PPBS,Lipid profile, Hb) |
0th day, 46th day 76th day |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
10/11/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aging is a natural process that causes several changes in the physical, psychological,
hormonal, and social status. Most of these changes are predicted to affect the quality of life of
the elderly. Geriatrics is the branch of medicine which deals with care of aged.Improving QoL
helps promote healthy ageing, reduce hospitalizations, and maintain dignity and
autonomy.Holistic interventions—including lifestyle changes and traditional medicine (like
Ayurveda)—may enhance multiple QoL domains.Quality of Life (QoL) in the elderly refers to an
individual’s perception of their position in life, considering physical health, psychological state,
level of independence, social relationships, and interaction with their environment.
One among eight specialities of Ashtanga Ayurveda is Rasayana which deals with
specific drugs and life style. Rasayana therapy is one of the useful methods of inducing a
healthy and active life. The Bhringarajadi rasayana mentioned in our classics helps to get rid of
diseases, lessens the impact of old age and premature death. The effect of this stimulant
makes even a blind person to see, makes one free from worries same like an elephant, which
walks without fear, a deaf or hearing impaired person can also listen to minute voice, becomes
disease free, attains hair as black as the black clouds and it rejuvenates pale and worn out
teeth.
A Quazi Experimental study will be conducted with a sample size of 56 participants without
regard to sex, while ensuring inclusion and exclusion criteria. Out of 56 participants, 28 each
will be consecutively selected and alternately allocated to study group and control group
ensuring equal representation in both groups. The study group will be advised to follow lifestyle
modification along with Bhringarajadi choorna 6 gram with jaggery twice daily after food , while
the control group is advised to follow lifestyle modification alone for 45 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. Data will be collected, processed and conclusions
will be drawn using appropriate statistical methods |