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临床试验/CTRI/2023/09/057661
CTRI/2023/09/057661尚未招募2 期

Evaluation of combined effect of Seka, Nitya Virechana and Kokilakshadi Kashaya in the management of Uttana Vataraktavis-à -vis Varicose Veins – An Open Label Single Arm Clinical Study.

Dr Dhanashree S1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年9月21日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Combined effect of Seka Nitya Virechana with internal administration of Kokilakshadi Kashaya in reduction of signs and symptoms of Uttana Vatarakta vis-a-vis Varicose Veins

研究概览

简要总结

Vatarakta is the condition caused by Dushti of Vata and Rakta,where Prakupita Rakta does Dushana and Margavarana of Vata andDushita Vata further does Dushana of Rakta. Vatarakta is of 2types-Uttana and Gambhira. Uttana Vatarakta Lakshanas**are Kandu, Daha, Ruk, Ayama etc.

Uttana Vatarakta can be co-related to Varicose Veins due tosimilarity in its symptoms.

Varicose veins are dilatedtortuous, superficial veins that results from defective structure and functionsof valves of saphenous veins, intrinsic weakness of the vein wall, highintraluminal pressure. Its incidence is 5% among Indianpopulation with more prevalence in women, obese and occupation that requiresprolong standing. Symptoms of varicose veins are dilated veins,dragging pain, night cramps, pigmentation of skin, pedal edema, heaviness,burning and itching sensation of lower limbs .

Intervention as percontemporary science is Surgical and Non-surgical methods. Surgicalinterventions includes stripping and ablation therapy. This may lead tocomplications like infection, hematoma, etc. Non-surgicalinterventions include elevation of limbs, compression stockings andsclerotherapy. This may lead to complications like  hyperpigmentation, allergic reactions tosclerosants, etc with higher recurrence rate. Hence, it is theneed of hour to find effective treatment for the better relief and arrest thefurther progression of the disease.

In Ayurveda, Nidanaparivarjana, Shodhana, Shamana are the common line of protocol in themanagement of disease. Snehayukta Virechana is explained as thetreatment in Vatarakta and Seka in UttanaVatarakta.  As, manyworks have been carried out on classical Virechana, Nitya Virechana and Sekais selected in the present study.

Hence, an effort is made toknow the combined effect of Nitya Virechana with NimbamritadiEranda Taila, Dashamula Ksheera Kashaya Seka with internal administrationof Kokilakshadi Kashaya in the management of Uttana Vatarakta.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •Subjects who fulfill diagnostic criteria.
  • •Subjects of age group 20- 65 years, irrespective of gender.
  • •Subjects who are fit for Nitya Virechana and Kashaya Seka.

排除标准

  • •Subjects having Varicose Veins associated with Venous Ulcer, Deep Vein Thrombosis or Cellulitis.
  • •Subjects with other systemic diseases that would interfere with the study like uncontrolled Diabetes Mellitus, uncontrolled Hypertension, etc., Pregnant women and lactating mothers.

结局指标

主要结局

Combined effect of Seka Nitya Virechana with internal administration of Kokilakshadi Kashaya in reduction of signs and symptoms of Uttana Vatarakta vis-a-vis Varicose Veins

时间窗: 0thday- before treatment | 8thday- after seka nityavirechana | 28thday- after treatment

次要结局

  • Combined effect of Seka Nitya Virechana with internal administration of Kokilakshadi Kashaya in reduction of signs & symptoms of Uttana Vatarakta vis-a-vis Varicose Veins(28 days)

研究者

发起方
Dr Dhanashree S
申办方类型
Other [self]

研究点 (1)

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