| CTRI Number |
CTRI/2022/02/040150 [Registered on: 09/02/2022] Trial Registered Prospectively |
| Last Modified On: |
07/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to assess the efficacy of Homeopathic medicines in the treatment of osteoarthritis of knee Joint In post menopausal woman by womac osteoarthritis Index in between Age Group of 40-60 years |
|
Scientific Title of Study
|
clinical study to assess the efficacy of Homeopathic medicines in the treatment for osteoarthritis of knee Joint in post menopausal woman by womac osteoarthritis Index |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSSateesh kumar |
| Designation |
Doctor PG scholar |
| Affiliation |
B.V.D.U Homoeopathic medical college and hospital ,dept of post graduate and research centre |
| Address |
Bharati vidhyapeeth (Deemed to be University) Homeopathic medical college and Hospital and Research center Bharati Educational Campus Pune Satara Road 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9492815889 |
| Fax |
|
| Email |
s.sateesh5889@Gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnil vishwanath patil |
| Designation |
Associate professor |
| Affiliation |
B.V.D.U Homoeopathic medical college and hospital ,dept of post graduate and research centre |
| Address |
Bharati vidhyapeeth (Deemed to be University) Homeopathic medical college and Hospital and Research center Bharati Educational Campus Pune Satara Road 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9890818201 |
| Fax |
|
| Email |
dranilpatil5258@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSSateesh kumar |
| Designation |
Doctor PG scholar |
| Affiliation |
B.V.D.U Homoeopathic medical college and hospital ,dept of post graduate and research centre |
| Address |
Bharati vidhyapeeth (Deemed to be University) Homeopathic medical college and Hospital and Research center Bharati Educational Campus Pune Satara Road 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9492815889 |
| Fax |
|
| Email |
s.sateesh5889@Gmail.com |
|
|
Source of Monetary or Material Support
|
| B.V.D.U Homoeopathic medical college and hospital ,dept of post graduate and research centre |
|
|
Primary Sponsor
|
| Name |
DrSSateesh Kumar |
| Address |
Bharati vidhyapeeth (Deemed to be University) Homeopathic medical college and Hospital and Research center Bharati Educational Campus Pune Satara Road 411043 |
| 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 |
| DrSSateesh Kumar |
BVDU Homoeopathic medical college and hospital,Dept of post graduate and research centre |
Department of Practice of Medicine
Bharati vidhyapeeth (Deemed to be University) Homeopathic medical college and Hospital and Research center Bharati Educational Campus Pune Satara Road 411043
Pune
MAHARASHTRA |
9492815889
s.sateesh5889@Gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVDUHMC Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Homoeopathic Medicine obtained after case taking will be administered to the patient.
Potency:30 ,200C,1M
Form: Pills ,Dilutions
Route of administration: Oral Route
Duration of Therapy: 3 Months
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.Subjects who have given consent for study.
2.Clinically diagnosed cases of knee osteoarthritis in post-menopausal women are recruited for study. |
|
| ExclusionCriteria |
| Details |
1.Subjects with complication of osteoarthritis like chondrolysis, bone death (osteonecrosis), Stress fractures, bleeding inside the joint, infection in the joint, etc; are excluded for study.
2.Subjects having raised levels of serum uric acid; positive RA are excluded for study.
3.Subjects with osteoarthritis associated with chronic and systemic disease like diabetes mellitus, hypertension, renal failures etc; are excluded for study.
4.Women who are on HRT [hormonal replacement therapy] calcium and vitamin D3 supplements are excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study the Role of Homoeopathic medicines in the treatment of Osteoarthritis of knee joint in post-menopausal women. |
WOMAC Index will be used at day 1 and end of study i.e 12 weeks to assess the effect of Homoeopathic medicine in the post menopausal women suffering from osteoarthritis of Knee joint. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the changes in WOMAC Scores before and after Homoeopathic treatment among knee OA in post-menopausal women |
WOMAC Index will be used at day 1 and for every follow up (i.e for every 15 days) till the end of study i.e 12 weeks to assess the effect of Homoeopathic medicine in the post menopausal women suffering from osteoarthritis of Knee joint. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
15/02/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Clinical Study to assess the effect of Homoeopathic Medicine in the treatment for Osteoarthritis of Knee joint in Post Menopausal Woman by using WOMAC Osteoarthritis Index.The duration of treatment will be three months and will be done on 30 patients at BVDUHMC Pune.
The primary outcome will be assessed using the follow up taken for 3 months to see the effectiveness of homoeopathic medicines in the treatment of Osteoarthritis of Knee joint in post menopausal women.
The secondary outcome will measure the improvement in symptoms of patients using WOMAC index at day 1 and at the end of 3rd month.
WOMAC Index will be used at day 1 and end of study i.e 12 weeks to assess the effect of Homoeopathic medicine in the post menopausal women suffering from osteoarthritis of Knee joint. |