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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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