Development of an automated portable Parisheka device and a comparative study of its efficacy with traditional Parisheka using Dashamoola Kashaya in Amavata (Rheumatoid Arthritis)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Improvement in pain scores (VAS) and Reduction in inflammatory markers (CRP, ESR) and achievement of Samyak Swedana Lakshana
Study Overview
Brief Summary
RESEARCH QUESTION
Does the development of an automated portable Parisheka device improve the efficiency in the administration of Dashamoola Kashaya Parisheka procedure and its effectiveness of pain management in Amavata compared to the traditional method of Parisheka?
HYPOTHESIS
Automated portable Parisheka device will be more efficient in the administration of Dasamoola Kashaya Parisheka procedure and more effective in the management of pain in Amavata compared to the traditional method of Parisheka
Null Hypothesis (Ho):
There is no difference in the efficiency of Dashamoola Kashaya Parisheka and its effectiveness in the management of pain in Amavata when done with automated portable Parisheka device compared to the traditional Parisheka procedure.
Alternative Hypothesis (H1):
The developed automated portable Parisheka device has superior efficiency in the administration of Dashamoola Kashaya Parisheka and is more effective in the management of pain in Amavata compared to the traditional Parisheka procedure.
AIM
Develop an automated portable Parisheka device and evaluate its efficacy compared to that of traditional Parisheka procedure in Amavata
OBJECTIVES:
Ø Primary Objective:
1. To develop an automated portable Parisheka device that is capable of administering Parisheka effectively and uniformly.
Ø Secondary Objective:
1. To check the Patient’s and Administrator’s responses during Parisheka procedure with automated portable Parisheka device and with current traditional method.
2. To evaluate and compare the efficacy of the automated portable Parisheka device with the traditional Parisheka method in Amavata (Rheumatoid Arthritis) by using Dashamoola Kashaya Parisheka and Pachana medicine.
3. To compare the changes in following parameters of Dermalab instrument before and after Dashamoola Kashaya Parisheka and Pachana medicine.
Ø Skin pH
Ø Skin sebum
Ø Skin hydration
Ø Skin color
Ø TEWL Video microscopy
Ø Skin Elasticity
Ø Temperature
4. To compare the changes in the following parameters before and after Dashamoola Kashaya Parisheka with Pachana medicine and compare it within 2groups.
A. Inflammatory markers ie., CRP, ESR
B. Samyak Swedan lakshana assessment.
C. Pain assessment with Visual Analoge Score
PLAN OF STUDY
The study will be carried out in the following phases
1. Survey study
2. Device Designing and Development
3. Validation
4. Clinical study
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients aged 20 to 60 years, irrespective of gender, presenting with clinical features of Amavata with Paithika characteristics such as Daha and Raga as described in Ayurvedic classics, and having a confirmed diagnosis of Rheumatoid Arthritis fulfilling the EULAR 2010 criteria, will be included.
- •The study will consider RA patients with tenderness and chronicity of less than 5 years or those who are freshly diagnosed.
- •Eligible participants must be suitable for Swedana procedures and should not have taken NSAIDs or short-acting steroids for the past 1–2 weeks.
- •Additionally, patients must be willing to provide informed consent and adhere to the study protocol.
Exclusion Criteria
- •Exclusion criteria include patients suffering from paralysis affecting motor function, diagnosed cases of neoplasm of the spine, gout, traumatic arthritis, or pyogenic osteomyelitis.
- •Patients with comorbidities such as cardiac disease, pulmonary tuberculosis, uncontrolled diabetes mellitus, inflammatory bowel disease, malignant hypertension, or renal function impairment, as well as pregnant women and lactating mothers, will not be included.
- •Individuals contraindicated for Swedana procedures or those with severe peripheral artery disease or other significant vascular conditions that could be worsened by Parisheka therapy are also excluded.
Outcomes
Primary Outcomes
Improvement in pain scores (VAS) and Reduction in inflammatory markers (CRP, ESR) and achievement of Samyak Swedana Lakshana
Time Frame: 0 days, 8 days or 15 days or 22 days
Secondary Outcomes
- • Patient’s and Administrator’s responses, Dermalab parameters during Parisheka using the automated portable device versus the traditional method.(0 days, 8 days or 15 days or 22 days)
Investigators
Dr ARUN N K
All India Institute of Ayurveda New Delhi