A clinical trial to compare the effect of vasayuktha vachadi upanaha with mahanarayana taila yuktha vachadi upanaha in the management of primary OA knee
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- TUG T test
Study Overview
Brief Summary
Osteoarthritis(OA) is by far the most common form of arthritis which shows a strong association with
ageing & is a major cause of pain & disability in the elderly. It is the most frequent joint disease
with a prevalance of 22% to 39% in India. As per Ayurveda OA knee is considered as Janu
Sandhigata vata which is a type of VataVyadhi affecting the Sandhi. Pathologically,it maybe defined
as a condition of synovial joints characterized by focal loss of articular hyaline cartilage with
proliferation of new bone& remodelling of joint contour. Swedana is the prime modality of treatment
for many diseases especially Vata &Kapha predominant diseases. Sthambhagna, Gouravaghna
,Sheetaghna are the main properties of Swedana. . Charaka has included Swedana karma under
Shadupakrama,where it is described as a principal method of treatment. Since degenerative OA can be
considered as Kevala Vatika associated with majja dhatu kshaya&shleshaka kapha kshaya ;Upanaha
which is an ideal tropical treatment in which Swedana is done by Bandhana is also indicated for
kevala vatika Condition.Even though it is effective with medium like taila ,for reducing pain only,by
looking forward for Majja dhatu &shleshaka kaphakshaya in Janusandhigata vata we can think about
usage of Vasa as a medium of application in Upanaha which is not studied yet properly.Hence,the
objectives of this study is to find the effect of Vachadi Upanaha with vasa in comparison with taila in
the Management of OA Knee. Vasa ,one among the important Chatusneha dravya ,which is not
commonly used as that of Taila &Ghritha is used here to compare Efficacy. The study is comparative
clinical trial with control group.Cases will be diagnosed based on the Kellagran-Lawrence radiological
scale of OA knee&also data is collected via observation,clinical case performa and xray. Participants
irrespective of sex, aged 45 – 65 years registered in OPD and IPD of Government Ayurveda college
Panchakarma Hospital, Thiruvananthapuram satisfying the inclusion criteria will be subjected to
consecutive sampling and the total of 30 participants will be selected for the study,where the trial
group will receive vachadi Upanaha with vasa and control group will receive the same with
Mahanarayana Taila.
Key words:Osteoarthritis, Upanaha,Vasa. Mahanarayana taila
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 45.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Participants irrespective of gender among age group 45-65years of age 2.Radiological changes as per grade 1 to 3 of kellgren-Lawrence radiological scale 3.Participants willing to give informed consent.
Exclusion Criteria
- •1 Known case of RA and other type of arthritis.
- •2 Congenital abnormalities 3 Participants with h/o any trauma fractured joint surgical diagnostic intervention with reference to the affected joint 4 Participants with uncontrolled diabetes mellitus FBS 160mg/dl and Hypertension,160/100mmhg severe liver and renal disorder Malignancy 5 Known case of dermatological disorders 6 Body mass index BMI40kg/m2.
Outcomes
Primary Outcomes
TUG T test
Time Frame: Intervention done for 14 days | Assessment will be done on 0th day,15th day,28th day
WOMAC osteoarthritis index
Time Frame: Intervention done for 14 days | Assessment will be done on 0th day,15th day,28th day
Range of movements using goniometry
Time Frame: Intervention done for 14 days | Assessment will be done on 0th day,15th day,28th day
safety by event evaluation scale
Time Frame: Intervention done for 14 days | Assessment will be done on 0th day,15th day,28th day
Secondary Outcomes
No secondary outcomes reported
Investigators
Amrutha Mohanan
Government Ayurveda College Thiruvananthapuram