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CTRI Number  CTRI/2025/06/088192 [Registered on: 04/06/2025] Trial Registered Prospectively
Last Modified On: 03/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Clinical Study on Calcarea carbonica 30C in Osteoarthritis of Knee Joint 
Scientific Title of Study   A clinical study to evaluate the effect of Calcarea carbonica 30C in Osteoarthritis of Knee by estimating the level of serum Hyaluronan Synthase  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  T.S.Asta Eshwaran 
Designation  Ph.D Scholar 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  Department of Materia Medica, Sarada Krishna Homoeopathic Medical College, Kulasekharam.

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9487607145  
Fax    
Email  dr.astaeshwar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.C.R.Krishnakumari Amma 
Designation  Ph.D Guide 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  Department of Materia Medica, Sarada Krishna Homoeopathic Medical College, Kulasekharam.

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9446615950  
Fax    
Email  drcrkrishnakumari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr.Winston Vargheese.V 
Designation  Ph.D Guide 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  Department of Materia Medica, Sarada Krishna Homoeopathic Medical College, Kulasekharam.

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9443692478  
Fax    
Email  drwinstonv@gmail.com  
 
Source of Monetary or Material Support  
Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari district, Tamil Nadu, India. Pin - 629161  
 
Primary Sponsor  
Name  Sarada Krishna Homoeopathic Medical college 
Address  Kulasekharam Kanniyakumari District Tamil Nadu, India. Pin - 629161 
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 T S Asta Eshwaran  Sarada Krishna Homoeopathic Medical College  Room No 303, Department of Materia Medica, Kulasekharam.
Kanniyakumari
TAMIL NADU 
9487607145

dr.astaeshwar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sarada Krishna Homoeopathic Medical College Institutional ethics Committee  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 medicine  Homoeopathic medicine will be given based on the symptomatology of patients. Calacrea carbonica 30C potency administered orally daily dose on morning up to treatment period of 6 months  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with Osteoarthritis of Knee
Patients with symptoms of Calcarea carbonica especially in osteoarthritis of knee and general symptoms.
Sex- Both males and female
Patients are willing to take only homoeopathic medicines.
 
 
ExclusionCriteria 
Details  Patients with any other seronegative arthritis.
Patients with severe structural deformities and other systemic complications.
Patients age below 45 and above 75 years.
Patient symptoms not indicated with Calcarea carbonica.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Alteration in the serum hyaluronan synthase level.
Changes in Knee Injury and Osteoarthritis Outcome Score(KOOS) values of patient.

 
6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of Life improved   6 months 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   16/06/2025 
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="1"
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  

In our day to day life, we usually faced the problems of joint pain and other associated symptoms irrespective to age and gender of the whole population. As the age increases, the problems created by the joints complaints also increases and affects the daily routine activities the person with such problems. Prevalence of Osteoarthritis is increasing in many developing countries due to westernization of diet, obesity, aging and other detrimental lifestyle changes. India may become the Osteoarthritis capital of the world with over 60 million cases by 2025, doctors say. Doctors say osteoarthritis is the most prevalent form of arthritis in India, affecting over 15 million adults every year. There is less awareness in people about homoeopathic treatment for Osteoarthritis knee. People suffering with osteoarthritis knee undergoing various kinds of treatment in order to get some relief from pain and stiffness.Osteoarthritis leads to complete disability of the Knee joint. If the pain is not relieved by medication or physiotherapy for long, a person may be bedridden in the long run. This medicine Calcarea carbonica 30C is cost effective, easily affordable by the patient and does not produce any side effects in the patients.The effectiveness of treatment is assess by using Knee Injury Osteoarthritis Outcome Score(KOOS) scale. KOOS was developed as an extension of WOMAC osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in persons suffering with knee injury and osteoarthritis. KOOS scoring system includes 5 separate score subscales, they are Symptoms, Pain, Activity of daily living, sports and recreational activity and knee related quality of life. KOOS scale was used in many osteoarthritis related researches

 
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