| CTRI Number |
CTRI/2024/11/077072 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial on the Homoeopathic Management of Osteoarthritis |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Medicine in the Management of Osteoarthritis: A single arm clinical study |
| 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 Hemlata |
| Designation |
Principal |
| Affiliation |
State Lal Bahadur Shastri Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory & Case Taking, Third Floor, Administrative Wing, State Lal Bahadur Shastri Homoeopathic Medical College and Hospital, Shantipuram, Phaphamau, Prayagraj, Uttar Pradesh
Shantipuram, Phaphamau, Prayagraj, Uttar Pradesh
Allahabad
UTTAR PRADESH
211013
India |
| Phone |
9452461704 |
| Fax |
|
| Email |
drhemlata2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aswini Kumar Das |
| Designation |
Professor |
| Affiliation |
State Lal Bahadur Shastri Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica, State Lal Bahadur Shastri Homoeopathic Medical College and Hospital, Shantipuram, Phaphamau, Prayagraj, Uttar Pradesh
Shantipuram, Phaphamau, Prayagraj, Uttar Pradesh
Allahabad
UTTAR PRADESH
211013
India |
| Phone |
9827925779 |
| Fax |
|
| Email |
draswinidas71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aswini Kumar Das |
| Designation |
Professor |
| Affiliation |
State Lal Bahadur Shastri Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica, State Lal Bahadur Shastri Homoeopathic Medical College and Hospital, Shantipuram, Phaphamau, Prayagraj, Uttar Pradesh
Shantipuram, Phaphamau, Prayagraj, Uttar Pradesh
Allahabad
UTTAR PRADESH
211013
India |
| Phone |
9827925779 |
| Fax |
|
| Email |
draswinidas71@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of Uttar Pradesh, AYUSH Anubhag - 2, Uttar Pradesh Shashan, Lal Bahadur Shastri Bhawan, Lal Bagh, Lucknow, Uttar Pradesh - 226001 (India) |
|
|
Primary Sponsor
|
| Name |
Government of Uttar Pradesh |
| Address |
AYUSH Anubhag - 2, Uttar Pradesh Shashan, Lal Bahadur Shastri Bhawan, Lal Bagh, Lucknow, Uttar Pradesh - 226001 (India) |
| 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 Aswini Kumar Das |
State Lal Bahadur Shastri Homoeopathic Medical College and Hospital |
OPD No. 15, Out Patient Department, State Lal Bahadur Shastri Homoeopathic Medical College & Hospital, Prayagraj, Uttar Pradesh - 211013
Allahabad
UTTAR PRADESH
Allahabad
UTTAR PRADESH |
9827925779
draswinidas71@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (2) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indiavidualized Homoeopathic Medicine |
Patients will be prescribed individualized homoeopathic on medicine after detailed case taking. Potency will be selected according to patient susceptibility based on homoeopathic principles, oral route of administration in globules each dose consist of 4 globules No. 30 moisten with indicated remedy. Repetition will be according susceptibility and improvement status |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases having symptoms of osteoarthritis
If patient was taking any acute medicine, he/she was included in the study after a washout
Patients willing to give consent either by signature or thumb impressions
|
|
| ExclusionCriteria |
| Details |
Patients with disability, bed- ridden patients are excluded.
Osteoarthritis associated with any uncontrollable chronic and systemic disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Osteoarthritis Quality of life score (OA Qol) |
0, 6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms |
0, 6, 12 months |
|
|
Target Sample Size
|
Total Sample Size="175"
Sample Size from India="175"
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)
|
01/01/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Osteoarthritis
is primarily disease of elderly affecting mostly the hip and knee joint. It is
a degenerative disease which affects the articular cartilage in the joints
gradually and eventually destroys it, leaving the affected person unable to
perform the routine work. Pain is the
main complain of patients to seek medical attention is pain. The pain also impacts
the quality of life. The conventional approach for osteoarthritis is pain
management with painkillers, pain-relieving lotions and non-steroidal
anti-inflammatory medicines (NSAIDs), but these have a number of adverse
effects, including renal failure and gastritis. homeopathic medicine is that it is having no
side effects and is cost effective. There are many studies in homoeopathy which
shows effectiveness homoeopathic treatment in osteoarthritis having no side
effect and is cost effective. Hence, this proposed study is an attempt to study
the scope of individualized homoeopathic medicine in the management of
Osteoarthritis in improve quality of life and reducing symptoms intensity of OA
such as the pain and improving the activity of daily. |