| 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
|
|
|
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
|
|
|
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 |