| CTRI Number |
CTRI/2025/02/080461 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Osteoporosis (Asthi Kshaya) and Bone Health in Adult Women of Eastern Uttar Pradesh |
|
Scientific Title of Study
|
Assessment of Asthi Kshaya(Osteoporosis) among adult female population of Eastern Uttar Pradesh with special reference to Bone Mineral Density(BMD). |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SURABHI DWIVEDI |
| Designation |
STUDENT |
| Affiliation |
Guru gorakhnath institute of medical sciences , faculty of Ayurveda |
| Address |
Guru Gorakshanth Institute of Medical Sciences , Faculty of Ayurveda , Arogya Dham, Balapar road, Sonabarssa, Gorakhpur
Gorakhpur
UTTAR PRADESH
273007
India |
| Phone |
9335506381 |
| Fax |
|
| Email |
ay01220096@mgug.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
SURABHI DWIVEDI |
| Designation |
STUDENT |
| Affiliation |
Guru gorakhnath institute of medical sciences , faculty of Ayurveda |
| Address |
Guru Gorakshanth Institute of Medical Sciences , Faculty of Ayurveda , Arogya Dham, Balapar road, Sonabarssa, Gorakhpur
Gorakhpur
UTTAR PRADESH
273007
India |
| Phone |
9335506381 |
| Fax |
|
| Email |
ay01220096@mgug.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr shantibhushan Handur |
| Designation |
professor |
| Affiliation |
Guru gorakhnath institute of medical sciences , faculty of Ayurveda |
| Address |
Guru Gorakshanth Institute of Medical Sciences , Faculty of Ayurveda , Arogya Dham, Balapar road, Sonabarssa, Gorakhpur
Gorakhpur
UTTAR PRADESH
273007
India |
| Phone |
09620979380 |
| Fax |
|
| Email |
shanthibhushan.handur@mgug.ac.in |
|
|
Source of Monetary or Material Support
|
| Guru Gorakshnath Instituter of Medical Sciences, Faculty of Ayurveda, Arogya Dham, Balapar road, Sonabarsa , Gorakhapur , Uttar Pradesh , pin code 273007, INDIA |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
: 61-65, opp. D Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi, 110058 |
| Type of Sponsor |
Government funding agency |
|
|
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 Shantibhushan Handur |
Guru Gorakshnath Institute of Medical Sciences , Faculty of Ayurveda |
Guru Gorakshanth Institute of Medical Sciences , Faculty of Ayurveda , Arogya Dham, Balapar road, Sonabarssa, Gorakhpur 273007
Gorakhpur
UTTAR PRADESH |
09620979380
shanthibhushan.handur@mgug.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| "Institutional Ethics Committee (Human Studies)" of GGIMS And MDAC of MGUG |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASTHI KLSHAYA(OSTEOPOROSIS) |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Adult women aged 45 years and older.
Participants exhibiting signs of bone-related disorders, such as joint pain, fragility, and history of fractures, suggestive of early or on-going bone density loss.
|
|
| ExclusionCriteria |
| Details |
Women with endocrine disorders, tuberculosis of the bone, history of systemic diseases like renal and hepatic disorders, or under long term medication affecting bone turnover were excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Determine the prevalence of Asthi Kshaya among adult female population of Uttar Pradesh
2.Understand and highlight socio-demographic ,diet and life style factors that increase susceptibility to bone density loss.
|
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NILL |
|
|
Target Sample Size
|
Total Sample Size="362"
Sample Size from India="362"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2025 |
| 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="0"
Months="3"
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
|
Asthi kshaya is a condition marked by the depletion of bone tissue,Which is a prevelence concern among the adult female,particularly in a regions with limited healthcare acess and nutritional inadequacies,such as Eastern Uttar Pradesh.Bone mineral density measurments is essentioal in diagnosing ostopenia and osteoporosis. Bone Mineral Density evaluation techniques used such as dual energy X ray absorptiometry (DXA) can aid in early detection of osteoporosis condition. Utlising the Ayurveda diagnostic principles alongside biomedical tools, this study seeks to bridge between traditional and modern health perspectives providing unique integrated approach to understand and address the bone health. |