A Clinical Trial To Study The Effect Of Rasabhra Guggulu In Patients With Varicose Veins.

Phase 3

Completed

Conditions: Varicose veins of lower extremities with inflammation. Ayurveda Condition: UTTANA-VATARAKTAM,

Brief Summary: This is a Randomized,open label,parallel group study comparing the safety and efficacy of Controlled drug [group-A] Kaishora Guggulu 3000 mg daily and the Trial drug [group-B] Rasabhra Guggulu 6000 mg daily for 28 days for 15 patients to each groups and will be conducted in Shri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, Kuthpady,Udupi, Karnataka, India. The Primary outcome measures will be assessed through VCSS [ Venous Clinical Severity Score] Before and After the treatment using Subjective and Objective parameters. The Secondary outcome incorporate the range of signs and symptoms of chronic venous disease to characterize the severity from C0 to C6 through CEAP [ clinical,ethiologic,anatomic,pathophysiologic] classification scheme and Disease specific Quality of Life will be Measured by Aberdeen Varicose veins Questionnaire [ AVVQ]. Hence an effort has been planned through this clinical study to prove the efficacy of Rasabhra Guggulu as effective against Uttana vatarakta w.s.r. to Varicose Veins.

Recruitment & Eligibility

Inclusion Criteria

PATIENT PRESENTING WITH MORE THAN FOUR OUT OF EIGHT SIGNS AND SYMPTOMS OF UTTANA VATARAKTA/VARICOSE VEINS WILL BE INCLUDED IN THE STUDY.
KANDU-ITCHING DAHA-BURNING SENSATION RUK-PAIN AAYAM-FEELING OF STRETCHING TODA-PRICKING PAIN SPHURANA-PULSATING SENSATION AAKUNCHANA-CONTRACTION SHYAVRAKTATWAK-SKIN DISCOLORATION.

Exclusion Criteria

PREGNANT WOMEN PROGRESSIVE GANGRENOUS CHANGES THROMBOPHLEBITIS BLEEDING ACUTE FAT NECROSIS ULCERATION DEEP VEIN THROMBOSIS.

Primary Outcome Measures

Name	Time	Method
VCSS[VENOUS CLINICAL SEVERITY SCORE]is used to Monitor the Changes in Venous diseases before and after the treatment using Subjective Parameters like shoola,daha and Objective Parameters like Shyavraktatwak,Aakunchana.	Time Frame [At baseline, 4 week]

Secondary Outcome Measures

Name	Time	Method
Disease-Specific Quality Of Life Measured by Aberdeen Varicose Veins Questionnaire [AVVQ]	4 week

Locations (1): Shri Dharmasthala Manjunatheshwara Ayurveda Hospital,Kuthpady,Udupi
🇮🇳
Udupi, KARNATAKA, India
Shri Dharmasthala Manjunatheshwara Ayurveda Hospital,Kuthpady,Udupi
🇮🇳Udupi, KARNATAKA, India
Dr Veerakumara K
Principal investigator
9743490753
khadiravana@gmail.com