A clinical trial to study the effects of two drugs,jatyadi taila & arjuna taila in patients with varicose ulcer
- Conditions
- Varicose veins of lower extremities with ulcer. Ayurveda Condition: DUSHTAVRANAH,
- Registration Number
- CTRI/2023/07/055247
- Lead Sponsor
- Dr Kavya A
- Brief Summary
*Dushtavrana*isa chronic type of wound resulted from varied aetiology. In contemporaryscience, it can be clinically correlated to chronic ulcers. Varicose ulcers areone among chronic venous ulcers. Venous ulceration is the most severe &debilitating outcome of chronic venous insufficiency in the lower limbswhich affects the quality of life of an individual by pain, itching, alteredappearance, loss of sleep, functional limitations. Venous disease isresponsible for around 85% of all chronic lower limb ulcers in resource-richcountries. Community based prevalence is 0.1-0.3% in adults(2-4% in elderly).The general line of treatment includes conservative approach such as Bisgaardmethod, compression therapy, vaccum assisted dressing, hyperbaric oxygen therapy,antibiotics, NSAIDs and surgical interventions like Thiersch grafting and laserablation have their own shortcomings. Nearly all venous ulcers can be healed,but even in those who have successful ablation or wear their stockingsreligiously, there is a 20–30% incidence of re-ulceration by 5 years.
*Sushruta*has explained *Shashti upakrama*in which specific avastha of *vranachikitsa* are highlighted. It includes *shodhanartha*& *ropanartha upakrama* like *kashaya, varthi, kalka, sarpi, taila,rasakriya* and *avachurnana.*Among them *taila*possess*kaphavatagna, vranashodhana,lekhana* properties & areindicated in *sadhyovrana, dushtavrana* &*dagdhavrana chikitsa*.Lipid soluble drugs can penetrate more rapidly than water soluble drugs at thecell surface to enter into the circulation very quickly.
*Arjuna*is mentioned as one among the drugs of *Nyagrodadigana*which is having *kashayarasa, ruksha guna, sheetha virya and vranya*properties whichcould be beneficial in *dushtavrana*.It has antioxidant, anti-inflammatory, analgesic, antimicrobial and antiviralproperties. Pre-clinical study conducted on topical applicationof *Terminalia arjuna* showedsignificant effect in histopathology and in wound healing.
Considering the above facts, anattempt is made to conduct clinical study aiming at establishing theeffectiveness of *Arjuna taila* in *Dushtavrana* (Varicose ulcer) *chikitsa*.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
- 1.Patients diagnosed with varicose ulcer having the features of varicose vein& ulcer presenting with itching, pain, discharge and discolouration of surrounding tissue.
- 2.Subjects aged between 20-60 years irrespective of gender, religion, socio-economic status & place.
- 3.Ulcer size within 10cm x 10cm.
- 4.Chronicity of ulcer upto1year.
- 5.Subjects irrespective of chronicity of varicose veins.
- 1.Patients aged above 60 years.
- 2.Patients with Deep vein thrombosis, malignancy, arterial diseases, bleeding disorders, cellulitis, gangrene & uncontrolled diabetes mellitus (HbA1c>6.5).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Bates Jensen wound assessment tool Assessment will be done on 0th, 7th, 14th, 21st, 30th day limited to 30 days. •VAS scale Assessment will be done on 0th, 7th, 14th, 21st, 30th day limited to 30 days. •Itching Assessment will be done on 0th, 7th, 14th, 21st, 30th day limited to 30 days.
- Secondary Outcome Measures
Name Time Method Quality of life Assessment will be done on 0th, 7th, 14th, 21st, 30th day limited to 30 days.
Trial Locations
- Locations (1)
S D M Institute of Ayurveda & Hospital
🇮🇳Bangalore, KARNATAKA, India
S D M Institute of Ayurveda & Hospital🇮🇳Bangalore, KARNATAKA, IndiaDr Kavya APrincipal investigator9108662989kavyaa@sdmayurbangalore.in