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CTRI Number  CTRI/2025/08/092151 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Homeopathy
Diagnostic 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Study on Combined Ayurvedic and Homeopathic Treatment for Reducing Pain and Improving Movement in People with Knee Osteoarthritis 
Scientific Title of Study   Integrated Approach in The Management of Knee Osteoarthritis - A Randomized Control Clinical Trial 
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 Suma Rajaput 
Designation  Assistant Professor  
Affiliation  KAHERs Shri B.M Kankanawadi Ayurveda Mahavidyalaya  
Address  Department of Swasthavritta KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi Belgaum KARNATAKA 590003 India

Belgaum
KARNATAKA
590003
India 
Phone  9036139698  
Fax    
Email  sumarajaput14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suma Rajaput 
Designation  Assistant Professor  
Affiliation  KAHERs Shri B.M Kankanawadi Ayurveda Mahavidyalaya  
Address  Department of Swasthavritta KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi Belgaum KARNATAKA 590003 India


KARNATAKA
590003
India 
Phone  9036139698  
Fax    
Email  sumarajaput14@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suma Rajaput 
Designation  Assistant Professor  
Affiliation  KAHERs Shri B.M Kankanawadi Ayurveda Mahavidyalaya  
Address  Department of Swasthavritta KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi Belgaum KARNATAKA 590003 India


KARNATAKA
590003
India 
Phone  9036139698  
Fax    
Email  sumarajaput14@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri BMKankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 590003 Karnataka India  
 
Primary Sponsor  
Name  KLE Academy of Higher Education and Research 
Address  Nehru Nagar Belagavi 590 010 Karnataka India  
Type of Sponsor  Research institution and hospital 
 
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 Suma Rajaput  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya   OPD 2 and OPD 17 Department of Swasthavritha and Yoga Shahapur 590003 Belgaum KARNATAKA 590003 India
Belgaum
KARNATAKA 
09036139698

sumarajaput14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research on Human Subjects   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 
Comparator Agent  ARNICA RHUS TOX  William Boericke Homeopthic manual of Materia Medica  
Comparator Agent  Bala Taila   Gadanigraha Vata vyadhi adhikara  
Intervention  Bala Taila and Arnica and Rhus Tox  Bala taila Janu basti for 7 days and oral administration of Arnica and Rhus tox for 30 days  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients from either sex with classical sign and symptoms of Knee OA
Patients of age group 40-70 years
 
 
ExclusionCriteria 
Details  Patients having major systemic disorders or other illnesses such as Hypothyroidism PCOS Cushing syndrome Hypersensitivity and Diabetes which interfere with the present study.
Patients with serious disease limiting life expectancy
Pregnancy and lactating mothers
Cognitive impairment congenital deformities
Not willing to participate in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Goniometry
ESR
CRP  
Baseline
Day 08
Day 31 
 
Secondary Outcome  
Outcome  TimePoints 
Visual analog pain scale
The Western Ontario and McMaster Universities Osteoarthritis index (WOMAC)
LYSHOLM Knee Scoring Scale
 
Baseline
Day 08
Day 31 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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/ Phase 3 
Date of First Enrollment (India)   01/09/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

OA is one of the most common joint disorders globally, affecting millions of people. Understanding its causes, progression, and management is essential due to its significant impact on quality of life, healthcare resources, and economic burden. OA is a chronic condition that can lead to chronic pain, disability, and reduced mobility [1]. Sandhigata Vata is the common form of articular disorder. It is most common degenerative joint disease in India.[1] Sandhigat Vata is a type of Vata Vyadhi mainly occurs in Vriddhavastha due to Dhatukshaya, which limits everyday activities such as walking, dressing, bathing etc. [2].

                        Integrating Ayurveda and homeopathy offers a broader range of treatment options for Sandhivata patients. Each system of medicine brings unique perspectives, diagnostic tools, and therapeutic modalities to the table, allowing for a more comprehensive and holistic approach to patient care.

Both Ayurveda and homeopathy emphasize personalized medicine, taking into account individual constitutional types, symptom profiles, and underlying imbalances. Integrating these systems allows for a more tailored and patient-centered approach to the management of Sandhivata, addressing the specific needs and characteristics of each patient.

                        Some Ayurvedic herbs and homeopathic remedies may have complementary or synergistic effects when used together. Researching the integration of Ayurvedic and homeopathic interventions for Sandhivata can help identify effective combinations that enhance therapeutic outcomes while minimizing adverse effects.

                        By studying the integrated approach to Sandhivata, researchers can evaluate the safety and efficacy of combining Ayurvedic and homeopathic treatments. This includes assessing potential herb-drug interactions, dose optimization, and long-term outcomes to ensure the safety and effectiveness of integrative protocols.

                        Integrating Ayurveda and homeopathy may improve healthcare accessibility by offering patients a wider range of treatment options that align with their cultural beliefs, preferences, and values. This integrative approach promotes patient empowerment and autonomy in healthcare decision-making.

While both Ayurveda and homeopathy have centuries-old traditions, there is a growing interest in generating scientific evidence to support their use in contemporary healthcare settings. Researching the integrated approach to Sandhivata provides an opportunity to contribute to the evidence base for complementary and alternative medicine, helping to bridge the gap between traditional knowledge and modern research methodologies.

                        In summary, studying the integrated approach to Sandhivata in both Ayurveda and homeopathy offers numerous potential benefits, including expanded treatment options, personalized medicine, synergistic effects, safety and efficacy evaluation, improved healthcare accessibility, and the advancement of research and evidence-based practice in complementary and alternative medicine.

 
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