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.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 20.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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
Time Frame: 0thday- before treatment | 8thday- after seka nityavirechana | 28thday- after treatment
Secondary Outcomes
- 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)