| CTRI Number |
CTRI/2024/12/078657 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
ETIOPATHOLOGICAL STUDY OF
OSTEOARTHRITIS [SANDHIVATA] IN POSTMENOPAUSAL WOMEN WITH SPECIAL REFERENCE TO FSH |
|
Scientific Title of Study
|
ETIOPATHOLOGICAL STUDY OF
OSTEOARTHRITIS [SANDHIVATA] IN POSTMENOPAUSAL WOMEN WITH SPECIAL REFERENCE TO FSH |
| 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 CHAMPA LAL KUSHWAH |
| Designation |
PG SCHOLAR ROGA NIDAN EVUM VIKRITI VIGYAN |
| Affiliation |
PT. KHUSILAL SHARMA GOVT. AYURVEDA COLLEGE & INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT.KOLAR NEHRU NAGAR BYPASS ROAD, BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India
SCIENCE HILLS BEHIND MANIT.KOLAR NEHRU NAGAR BYPASS ROAD, BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9039156934 |
| Fax |
|
| Email |
dr.clkushwah91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJESH JAIN |
| Designation |
LECTURER OF ROGA NIDAN EVUM VIKRITI VIGYAN DEPARTMENT |
| Affiliation |
PT. KHUSILAL SHARMA GOVT. AYURVEDA COLLEGE & INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT.KOLAR NEHRU NAGAR BYPASS ROAD, BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India
SCIENCE HILLS BEHIND MANIT.KOLAR NEHRU NAGAR BYPASS ROAD, BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9827730455 |
| Fax |
|
| Email |
rajeshjain1075@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAJESH JAIN |
| Designation |
LECTURER OF ROGA NIDAN EVUM VIKRITI VIGYAN DEPARTMENT |
| Affiliation |
PT. KHUSILAL SHARMA GOVT. AYURVEDA COLLEGE & INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT.KOLAR NEHRU NAGAR BYPASS ROAD, BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India
SCIENCE HILLS BEHIND MANIT.KOLAR NEHRU NAGAR BYPASS ROAD, BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9827730455 |
| Fax |
|
| Email |
rajeshjain1075@yahoo.com |
|
|
Source of Monetary or Material Support
|
| PT KHUSILAL SHARMA GOVT AUTO AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
|
|
Primary Sponsor
|
| Name |
PT KHUSILAL SHARMA GOVT AUTO AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD, BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 CHAMPA LAL KUSHWAH |
PT KHUSILAL SHARAMA GOVT AUTO AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD, BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India
Bhopal
MADHYA PRADESH |
9039156934
dr.clkushwah91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M171||Unilateral primary osteoarthritisof knee. Ayurveda Condition: SANDHIGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
41.00 Day(s) |
| Age To |
70.00 Day(s) |
| Gender |
Female |
| Details |
1.Patients having signs and symptoms of
Osteoarthritis.
2.Patients between the age group of 41 to 70
years, Post meno pausal Womens and irrespective
of socioeconomic status.
3.Patients willing to sign consent form for the
study. |
|
| ExclusionCriteria |
| Details |
1.Patient not fulfilling the inclusion
criteria.
2.Patients having any type of arthropathy like
Gout, Rheumatoid arthritis, Traumatic arthritis,
Neoplasm of spine & Pyogenic osteomyelitis etc.
3.Patients having Paralysis and associated
diseases like Cardiac disease, Malignancy,
Tuberculosis, Diabetes Mallitus, Hypothyroidism,
Hyperthyroidism, Renal Function impairment,
Hypertension, RHD etc.
4.Pregnant women and Lactating mothers and having
havey bleeding.
5.Patients having any anatomical deformity will be
excluded.
6.Patients who are not willing to give written
consent for participating in research study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of study we would be able to explore the relationship between serum FSH in postmenopausal womens in the case of osteoarthritis. It is further expected that this study will be helpful in practice for the management of osteoarthritis. |
It is expected that at the end of study we would be able to explore the relationship between serum FSH in postmenopausal womens in the case of osteoarthritis. It is further expected that this study will be helpful in practice for the management of osteoarthritis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is further expected that this study will be helpful
in clinical practice for the prevention as well as
management of Osteoarthritis(Sandhivat)
in present era. |
It is further expected that this study will be helpful
in clinical practice for the prevention as well as
management of Osteoarthritis(Sandhivat)
in present era. |
|
|
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)
|
14/01/2025 |
| 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
|
It is expected that at the end of study we would be able to explore the relationship between serum FSH in postmenopausal womens in the case of osteoarthritis. It is further expected that this study will be helpful in practice for the management of osteoarthritis. |