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CTRI Number  CTRI/2024/09/073517 [Registered on: 06/09/2024] Trial Registered Prospectively
Last Modified On: 04/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Homoeopathic Management of Pain and quality of life of Knee Osteoarthritis Patients of peri menopausal women 
Scientific Title of Study   Effectiveness of Individualized Homoeopathic Medicines in the management of Pain and Quality of life among patients with knee Osteoarthritis of Climacteric age group using Kents repertory A Single Group Pre-Post Interventional 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 Md Achhim Laskar 
Designation  Post Graduate Trainee 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital Dr Bholanath Chakraborty sarani Doomurjola Department of repertory room no 1,9.

Haora
WEST BENGAL
711104
India 
Phone  7001794953  
Fax    
Email  laskarmdachhim@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR PRADIP KUMAR BAIRI 
Designation  Professor and Head of department of Repertory 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital Dr Bholanath Chakraborty sarani Doomurjola Department of Repertory Room no 1,9.

Haora
WEST BENGAL
711104
India 
Phone  09433122932  
Fax    
Email  drpkbairi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR PRADIP KUMAR BAIRI 
Designation  Professor and Head of department of Repertory 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital Dr Bholanath Chakraborty sarani Doomurjola Department of Repertory Room no 1,9.

Haora
WEST BENGAL
711104
India 
Phone  09433122932  
Fax    
Email  drpkbairi@gmail.com  
 
Source of Monetary or Material Support  
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital Dr Bholanath Chakraborty sarani Doomurjola Howrah 711104 West Bengal 
 
Primary Sponsor  
Name  Dr Md Achhim Laskar 
Address  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital Dr. B.N.Chakraborty sarani, Doomurjola, Howrah-711104, West Bengal 
Type of Sponsor  Other [self] 
 
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 Md Achhim Laskar  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital Dr Bholanath Chakraborty sarani Doomurjola Department of Repertory Room no 1,9.
Haora
WEST BENGAL 
7001794953

laskarmdachhim@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicine   All patients enrolled in the study will be receiving homoeopathic medicine on the basis of individualization. Both centisimal and fifty millesimal potencies will be used will given 1month interval of six month. patients will take medicine according to direction. All medicine procured will be GMP certified. Along with medicines, the patients will recive dietary advice. Diet mannagement according to individual patients requirements.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Female of climacteric age group (age between 40 to 60 year).
2. Radiological evidence of OA unilateral or bilateral.
3. Patient presenting with symptom of OA suffering more than 6 months.
4. Patient who are not undergo homoeopathic treatment for last two weeks. 
 
ExclusionCriteria 
Details  1. Advanced pathological or grade -4 OA.
2. Rheumatoid Arthritis (RA) or other types of inflammatory arthritis excluded
symptomatically.
3. Patient suffering from any severe chronic medical or surgical disease like
malignancy, organ failure etc.
4. Diagnosed psychological, personality and neurological disorders such as dementia
Alzheimer’s disease, parkinsonism. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in terms of severity will be assessed by Visual Analogue scale  Ai base line and after six month of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of quality of life by eq-5d-5l   Each Patients will get follow-up at least 6 months at the interval of 1 month 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
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)   20/09/2024 
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="6"
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  

INTRODUCTION:

 Osteoarthritis (OA) is the commonest musculoskeletal disorder in older individuals, and it is the leading cause of pain, and physical disability .According to the American College of Rheumatology Diagnostic and Therapeutic Criteria Committee, Osteoarthritis is defined as a heterogeneous group of conditions leading to joint symptoms and signs which are associated with defective integrity of articular cartilage along with changes in the underlying bone at the joint margins. Pain is the most prominent and disabling symptom of OA resulting in reduced participation in activities and negative effects on mood, sleep, and overall quality of lifeKnee OA is the most common type of OA compared to other joints results in greater physical disability. Development of osteoarthritis include systemic, joint environment and joint overloading factors. Increasing age, female sex, heredity and race are the systemic risk factors. In females, the estrogen deficiency during the menopausal age affects not only the bone and articular cartilage directly but also increases the chance of being obese that in turn will lead to an increase in joint overloading. 

The epidemiological studies show that osteoarthritis affects people above the age of 50 years and more prevalent among female gender. It is suggest that the hormonal changes of menopausal women especially decreasing  estrogen level, lead to increasing OA. OA is the 2nd most common rheumatological problem and most frequent joint disease. The prevalence of osteoarthritis in India ranges from 22%- 39%.  In a WHO study, it has been revealed that by the year 2050, 130 million will suffer from osteoarthritis worldwide, of whom 40 million will be disabled by the disease. Globally, knee osteoarthritis is the fourth significant cause of incapability in women and eighth in men.

Modern system of medicine:

NSAIDs are the most popular drugs to treat osteoarthritic pain. They can be administered either topically or orally. In clinical trials, oral NSAIDs produce ~30% greater improvement in pain than high-dose acetaminophen. Occasional patients treated with NSAIDs experience dramatic pain relief, whereas others experience little improvement. Initially, NSAIDs should be administered topically or taken orally on an “as needed”.

Homeopathy is a natural, safe and effective treatment option for those suffering from osteoarthritis of knee joint of a climacteric age group patient. This alternative medical system was developed by German physician and chemist Dr. Samuel Hahnemann. In Homoeopathy the innermost core of philosophy allows treating the patient on the idea of individualization. Homoeopathy acts both as a preventive moreover as a curative mode of treatment because it relies on the totality of presenting symptoms regardless of the name of disease. The totality includes subjective and objective understanding about the disease state where the underlying cause and also the individual’s susceptibility are being addresses There is a need for medicines that have good efficacy without having side effects, which have low toxicity to the patients with OA. The homeopathic system of medicine has remedies that are already proven on human beings having no side effects to the patients, yet are effective.                                                                                                                             

JUSTIFICATION OF THE STUDY: Although many studies have been done on osteoarthritis of knee joints in all age groups but study on climacteric group is still remain scarce in Homoeopathy. Modern system of medicines use NSAIDS for treatment of such cases which are having short term relief in pain as well as adverse effects in many organs such as kidney, heart etc. with no signifacant improvement in quality of life. Homoeopathic treatment is based on the simple principal of symptoms similarity. With the availability of a great array of remedies in the modern scenario, homoeopathy has a great scope in relieving the long standing symptoms of climacteric woman suffering from osteoarthritis of knee joint and improving overall health related quality of life by administering Individualized Homoeopathic Medicine after through case taking and repertorization using Kent’s repertory.

RESEARCH QUESTION: Is Individualized Homoeopathic Medicine effective in managing the pain and quality of life in patients with OA knee of climacteric age group?

HYPOTHESIS:

Null Hypothesis (HO)There is no significant role of individualized homoeopathic medicines in managing the pain and quality of life in patients of OA Knee of climacteric age group.

Alternative Hypothesis (HA): Individualized homoeopathic medicines has significant role in managing the pain and quality of life in patients of OA Knee of climacteric age group.

 
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