A Comparative clinical study to evaluate the efficacy of sahacharadi kashaya with vasaguduchyadi kashaya preceded by sahacharadi taila matrabasti in siraja granthi vis - a - vis Varicose veins
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Compare the efficacy of sahacharadi kashaya and vasaguduchyadi kashaya preceded by sahacharadi taila matra basti in reduction of symptoms of siraja granthi i.e varicose veins through statistical tests
Study Overview
Brief Summary
Varicose veins are the penalty of vertically against gravity
Varicose veins mostly occur due to incompetence of the valves of veins they being dilated tortuous elongated veins in the leg affects both the superficial as well as the deep veins Clinical features of varicose vein are dull aching pain heaviness in the limb ankle oedema darkening and pigmentation of the skin itching burning sensation and night cramps It is a common condition in India Incidence is 5 percent of adult population and the prevalence of varicose vein is 30 to 50 percentage while 25-30 percentage in women and 15percentage in men They are more common in lower limbs because of erect posture and long columns of blood has to be supported which can lead to weakness and incompetency of valves
In contemporary science, management of varicose veins includes administration of Diuretics topical steroids Ablative procedures sclerotherapy and surgery Sometimes they may lead to complications like deep vein thrombosis hematomas damage to adjacent saphenous or sural nerve infection and anaphylaxis which is a very rare but severe complication
In Ayurvedic literature it may be correlated with Sirajagranthi which presents with sampeedana (compression) sankochana(constriction) vishoshana (Dryness) and vakreekarana (Tortuosity )of Sira Treatment for this condition includes sahachara taila Pana Basti vataghna upanaha and siravyadha
Matrabasti selected for the study is indicated in vyayamasakta (debilitated due to excessive physical work) It is vataroganut (destroys vata dosha)
Sahacharadi taila selected for the study contains sahachara dashamoola lohita priyangu and is vatahara
Sahacharadi Kashaya selected for the study is vatakaphahara raktashodhaka shothahara kandughna vedanasthapaka
Vasaguduchyadi kashaya contains vasa guduchi aragwadha which destroys the diseases originated from the vitiation of vata and rakta
These medicinal drugs and therapeutic procedures are cost effective free of complication and helpful in the above condition Based on this the study has been taken to compare the efficacy of Sahacharadi Kashaya with Vasaguduchyadi Kashaya followed by Sahacharadi taila matrabasti in siraja granthi
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects with the signs and symptoms of siraja granthi vis A vis varicose veins as mentioned in textbooks will be included Subjects of all genders of age group between 30-70 years will be included Subjects who come under CEAP classification of varicose vein (C0-C4)(15) subjects with symptoms of varicose vein like dull aching pain heaviness in the limb itching burning sensation and night cramps with or without reticular veins or telangiectasias visible tortuous dilated elongated veins edema and skin changes will be included Both fresh and treated cases of Siraja Granthi will be taken for the study.
Exclusion Criteria
- •Subjects with congenital varicose vein will be excluded Subjects diagnosed with varicose vein due to secondary causes like abdominal tumour retroperitoneal fibrosis lymphadenopathy ascites will be excluded Subjects with complications like DVT Eczema and Venous ulcers will be excluded Subjects with Uncontrolled Diabetes mellitus (RBS more than 250mg dL) will be excluded Subjects with Uncontrolled Hypertension (more than140 90 mm of Hg) will be excluded.
- •Subjects who are unfit for Basti procedure will be excluded Pregnant and lactating women will be excluded Subjects diagnosed with systemic diseases that may interfere with the study will be excluded.
Outcomes
Primary Outcomes
Compare the efficacy of sahacharadi kashaya and vasaguduchyadi kashaya preceded by sahacharadi taila matra basti in reduction of symptoms of siraja granthi i.e varicose veins through statistical tests
Time Frame: At Baseline,8th Day,38th day
Secondary Outcomes
- Reduction in the symptoms of siraja granthi i.e varicose veins like dull aching pain in lower limbs itching burning sensation tortousity of veins edema and skin pigmentation through scales of measurement symptoms(At Baseline,8th Day,38th day)
Investigators
Dr Lalita Suranagi
Government ayurveda medical college Mysuru