| 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
|
|
|
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
|
|
|
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. |