| CTRI Number |
CTRI/2024/07/071629 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Discover the Power of Homoeopathic Calcarea Fluor 6x for Knee Health |
|
Scientific Title of Study
|
A Clinical Study To Assess The Effect Of
Biochemic Medicine Calcarea Fluor 6X In
Management Of Osteoarthritis Of Knee |
| 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 Sonu Patel |
| Designation |
PG Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
| Address |
Jawaharlal Nehru Homoeopathic Medical College, Department of Practice of Medicine, Post graduation division, Parul University, P.O.Limda, Ta. Waghodia, Dist. Vadodara, Vadodara, Gujarat 391760 Jawaharlal Nehru Homoeopathic Medical College, Department of Practice of Medicine, Post graduation division, Parul University, P.O.Limda, Ta. Waghodia, Dist. Vadodara, Vadodara, Gujarat 391760 Vadodara GUJARAT 391760 India |
| Phone |
7990221049 |
| Fax |
|
| Email |
sonupatel79902@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Devendra Jadav |
| Designation |
PROFESSOR, PRACTICE OF MEDICINE DEPARTMENT |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical college and Hospital |
| Address |
Jawaharlal Nehru Homoeopathic Medical College, Department of Practice of Medicine, Post graduation division, Parul University, P.O.Limda, Ta.Waghodia, Dist. Vadodara, Vadodara, Gujarat 391760 Jawaharlal Nehru Homoeopathic Medical College, Department of Practice of Medicine, Post graduation division, Parul University, P.O.Limda, Ta.Waghodia, Dist. Vadodara, Vadodara, Gujarat 391760 Vadodara GUJARAT 391760 India |
| Phone |
9825222758 |
| Fax |
|
| Email |
devendrasinhjadav207@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sonu Patel |
| Designation |
PG Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
| Address |
Jawaharlal Nehru Homoeopathic Medical College, Department of Practice of Medicine, Post graduation division, Parul University, P.O.Limda, Ta. Waghodia, Dist. Vadodara, Vadodara, Gujarat 391760 Jawaharlal Nehru Homoeopathic Medical College, Department of Practice of Medicine, Post graduation division, Parul University, P.O.Limda, Ta. Waghodia, Dist. Vadodara, Vadodara, Gujarat 391760 Vadodara GUJARAT 391760 India |
| Phone |
7990221049 |
| Fax |
|
| Email |
sonupatel79902@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Medical College And Hospital, Parul University, P.O.Limda, Ta.Waghodia, Dist. Vadodara, Vadodara, Gujarat 391760
India
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Homoeopathic Medical And Hospital |
| Address |
Jawaharlal Nehru Homoeopathic Medical College, Department of Practice of Medicine, Post graduation division, Parul University, P.O.Limda, Ta.Waghodia, Dist.Vadodara, Vadodara, Gujarat 391760 |
| Type of Sponsor |
Private 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 |
| Dr Sonu Patel |
Jawaharlal Homoeopathic Medical College And Hospital |
Jawaharlal Nehru Homoeopathic Medical College, Department of Practice of Medicine, Post graduation division, Parul University, P.O.Limda, Ta.Waghodia, Dist.Vadodara, Vadodara Vadodara GUJARAT |
7990221049
sonupatel79902@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Homoeopathic Medical College And Hospital INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Biochemic Medicine Calcarea Fluor 6x. |
Homoeopathic Biochemic Medicine Calcarea Fluor 6x. Duration of Therapy 3 Months. Administration of Medicine in minimal doses and dry on the tongue or dissolved in a spoonful of water.
Dosage 4 tablets three times a day.
Frequency of dosage In acute cases, a dose every hour or two; in severe, painful affections, a dose every ten to fifteen minutes; in chronic affections, one to four doses daily.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases diagnosed with ACR criteria of
osteoarthritis of knee.
2. Patients between 45 to 70 years of age.
3. All socio-economical status.
4. Gender – both male & female.
5. Cases in which Patients who will give written consent.
|
|
| ExclusionCriteria |
| Details |
1. Cases with secondary OA.
2. Patients suffering from Pre-diagnosed
Autoimmune disorders.
3. Cases with stage 4 (severe) OA knee.
4. Cases of pregnant women and lactating mothers.
5. An accidental death.
6. Cases with irregular follow-ups or less than
minimum 6 follow-ups.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the severity and outcome of patients having osteoarthritis of knee before and after treatment with the use of self-made questionnaire. |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the common occupations among patients suffering from osteoarthritis of knee. |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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 2 |
|
Date of First Enrollment (India)
|
12/08/2024 |
| 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 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
|
· Osteoarthritis is a common degenerative joint disease causing pain, swelling, and stiffness, primarily affecting knees, hips, spine, and hands. It limits mobility and daily activities, often termed as "wear and tear" arthritis. The high prevalence in modern times leads to joint disability. Schussler’s theory suggests disease results from disturbed molecular motion of cell salts in tissues, rectifiable by administering small quantities of the same mineral salts and Loss of Calcarea Fluor in the system can lead to the development of hard, knotty exudations on bone surfaces and inflammation of the knee joint with associated joint cracking so, Biochemic salt supplementation is proposed to prevent knee osteoarthritis progression. · A non-randomized study will be conducted to assess the effect of calcarea fluor 6x in osteoarthritis of knee. The study will investigate the potential benefits of Homoeopathy in managing osteoarthritis of knee. The study will enroll 42 patients and will be conducted at the Jawaharlal Nehru Homoeopathic Medical College, Parul University, Vadodara, Gujarat, India. · Case taking according to Dr. Hahnemann’s Organon of Medicine guidelines, Diagnosed of knee osteoarthritis using ACR criteria, necessary investigations as per case requirements, Assessment and evaluation of osteoarthritis of knee would be done using the self-made questionnaire based on Womac Index and treatment with Calcarea Fluor in 6X potency, and follow-up every fifteen days or as and when required. |