| CTRI Number |
CTRI/2025/02/079895 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
|
| Type of Trial |
Observational |
|
Type of Study
|
Analytical |
| Study Design |
Other |
|
Public Title of Study
|
Relation in between bone mineral density and serum calcium level with Asthi Dhatu kshaya lakshana(like hair fall, body pain, joint pain,weakness etc.) |
|
Scientific Title of Study
|
Study to find out relation between bone minetal density score and serum calcium level
with lakshana of Asthidhatu kshaya. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Satnam |
| Designation |
PG scholar |
| Affiliation |
Institute for Ayurved Studies And Research |
| Address |
Department of Rog nidan evum vikriti vigyan Institute for Ayurved
Stuidies and Research Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
8570810629 |
| Fax |
|
| Email |
satnamsain86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRandhir Singh |
| Designation |
Associate professor of Rog nidan evum vikriti vigyan Department |
| Affiliation |
Institute for Ayurved Studies And Research |
| Address |
Department of Rog Nidan Evum Vikriti Vigyan Institute for Ayurved
Studies and Research Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
9416133098 |
| Fax |
|
| Email |
singhrandhir13476@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Satnam |
| Designation |
PG scholar |
| Affiliation |
Institute for Ayurved Studies And Research |
| Address |
Department of Rog nidan evum vikriti vigyan Institute for Ayurved
Stuidies and Research Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
8570810629 |
| Fax |
|
| Email |
satnamsain86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved studies and Research Umri Road Sector 8 Kurukshetra 136118 Shri Krishna
AYUSH University |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved studies and Research |
| Address |
Institute for Ayurved studies and Research Umri Road Sector 8
Kurukshetra 136118
|
| 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 |
| DrSatnam |
Institute for Ayurved studies and Research Hospital |
Room no 72d first floor
Rog Nidan Evum Vikriti
vigyan Department
Kurukshetra
HARYANA
Kurukshetra
HARYANA |
8570810629
satnamsain86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Person with lakshana of Asthi Dhatu kshaya. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Day(s) |
| Age To |
50.00 Day(s) |
| Gender |
Both |
| Details |
1.Patients having Asthi Dhatu kshaya lakshana like hair fall, joint pain,generelised weakness,muscle pain ect having age 21-50 years.
2.Patients of both sexes male and females will be taken. |
|
| ExclusionCriteria |
| Details |
1.Patients age group below 21 years and above 50 years not to be taken.
2.Patients not willing for consent.
3.Patients suffering from any chronic disease not to be taken. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This will help to find out relation between BMD score and serum calcium level with Asthi Dhatu kshaya lakshana. |
40 to 45 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This will also help to cure the patients and the prevent the progression of prevalence rate of disease and spread awareness. |
40 to 45 minutes |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="1"
Months="1"
Days="6" |
|
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
|
An Analytical study has been designed to find out the relation between bone mineral density and serum calcium level with Asthi Dhatu kshaya lakshana, between the age group of 21 to 50 years irrespective of sex and participants with lakshana of Asthi Dhatu kshaya are to be selected from OPD and IPD of IAS&R Hospital, Kurukshetra. |