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临床试验/CTRI/2024/08/072836
CTRI/2024/08/072836尚未招募3 期

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

Dr Prashant Patel1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
1. To assess the improvement in pain using the VAS score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

1. To assess the improvement in pain using the VAS score

时间窗: 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

时间窗: both outcomes have Sem time points: | 1st day,15th day,45th day,60th day of visit

次要结局

  • 1. To assess the changes in the distribution of Telangiectasias(2. To observe changes in skin thickness and intensity through Derma Lab Combo.)

研究者

发起方
Dr Prashant Patel
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Prashant Patel

Amrita School of Ayurveda

研究点 (1)

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