Combined Effect of Lower Limb Exercise and Leg Massage With Sahacharadi Taila Compared to Lower Limb Exercise in Varicose Vein (CEAP 1&2): A Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- 1. To assess the improvement in pain using the VAS score
Study Overview
Brief Summary
Background
Varicose veins (VV) are twisted dilated elongated tortuous veinsof the lower limb and have been considered a cosmetic problem. However, varicosities may cause pain, loss of working days, disability, and discomfort, and it adversely affects the health-related quality of life (QoL).
As per Acharya Sushruta and Vagbhata, the Varicose vein can be correlated to “Sirajagranthi†and is described in the context of the Granthi-apachi-arbuda-galaganda chapter.
In Ashtanga Hridayam Chikitsa Sthana describes Sahacharadi taila; the same formulation has been described in Sahasrayogam as an external application. Sahacharadi taila is recognized for its anti-inflammatory and rejuvenating qualities.
Non-pharmacological treatments include exercise training, which aims to enhance calf muscle pump function and is found to be a beneficial therapy for varicose vein treatment.
Purpose of the study
The purpose of this randomized clinical trial is to combine supervised lower limb exercise and leg massage with Sahacharadi Taila can provide a comprehensive approach targeting both the physical activity aspect and the potential benefits of massage.
The rationale for the study lies in the need to explore a comprehensive and holistic approach to managing varicose veins in their early stages, combining conventional exercise with traditional Ayurvedic leg massage, and evaluating the potential benefits in terms of symptom relief, prevention of progression, and improvement in overall quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.CEAP classification C one and C two of varicose veins 2.Patient with Varicose vein in bilateral lower limb 3.Ability to participate in supervised exercise sessions.
- •4.Participants to perform leg massages with Sahacharadi Taila.
Exclusion Criteria
- •1.History of deep vein thrombosis or other serious vascular diseases.
- •2.History of allergy to oil appliances 3.Patients with low back ache, Hip joint pain, and other morbidities who can not perform exercise.
Outcomes
Primary Outcomes
1. To assess the improvement in pain using the VAS score
Time Frame: both outcomes have Sem time points: | 1st day,15th day,45th day,60th day of visit
2. Improvement in Quality of Life using AVVQ & SF-36
Time Frame: both outcomes have Sem time points: | 1st day,15th day,45th day,60th day of visit
Secondary Outcomes
- 1. To assess the changes in the distribution of Telangiectasias(2. To observe changes in skin thickness and intensity through Derma Lab Combo.)
Investigators
Dr Prashant Patel
Amrita School of Ayurveda